Disclaimer
This information collection is a core HTA, i.e. an extensive analysis of one or more health technologies using all nine domains of the HTA Core Model. The core HTA is intended to be used as an information base for local (e.g. national or regional) HTAs.

Fecal Immunochemical Test (FIT ) versus guaiac-based fecal occult blood test (FOBT) for colorectal cancer screening

Fecal Immunochemical Test (FIT) for colorectal cancer screening compared to CRC screening with Guaiac –based fecal occult blood test (gFOBT) in the screening of Adenomas, as non-malignant precursor lesions of ColoRectal Cancer (CRC). in healthy and/or asymptomatic adults and elderly Any adult over 50 years old, both men and women, with average risk of CRC.

(See detailed scope below)

HTA Core Model Application for Screening Technologies 1.0
Core HTA
Published
Tom Jefferson (Agenas - Italy), Marina Cerbo (Agenas - Italy), Nicola Vicari (Agenas - Italy)
Mirjana Huic (AAZ), Agnes Männik (UTA - Estonia), Jesus Gonzalez (ISCIII - Spain), Ingrid Rosian (GÖG - Austria), Gottfried Endel (HVB - Austria), Valentina Rupel (IER - Slovenia), Alessandra Lo Scalzo (Agenas - Italy), Ingrid Wilbacher (HVB - Austria)
Agenas - Agenzia nazionale per i servizi sanitari regionali
AAZ (Croatia), AETSA (Spain), A. Gemelli (Italy), Avalia-t (Spain), CEIS (Italy), CEM (Luxembourg), GÖG (Austria), HAS (France), HVB (Austria), IER (Slovenia), ISCIII (Spain), Laziosanità (Italy), NCPHA (Bulgaria), NIPH (Slovenia), NSPH (Greece), NSPH MD (Romania), Osteba (Spain), Regione Veneto (Italy), SBU (Sweden), SNHTA (Switzerland), THL (Finland), UTA (Estonia).
5.4.2013 13.07.00
31.7.2014 9.21.00
Jefferson T, Cerbo M, Vicari N [eds.]. Fecal Immunochemical Test (FIT ) versus guaiac-based fecal occult blood test (FOBT) for colorectal cancer screening [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali; 2014. [cited 2 December 2022]. Available from: http://corehta.info/ViewCover.aspx?id=206

Fecal Immunochemical Test (FIT ) versus guaiac-based fecal occult blood test (FOBT) for colorectal cancer screening

<< Social aspectsCollection appendices >>

Authors: Ingrid Wilbacher

Summary

 

Rights

Duties/responsibilities

Patient

Sufficient information and informed consent {86, 87, 92}

Participation/compliance

 

right of access to (best) health care {12,13,14}

Risk reduction

 

"freedom in participation" {16, 87}

Allow data use for adequate follow up and fluent follow up in case of positive test result

 

Data protection {21}

Pay tax or health insurance contributions

 

Access without discrimination {25-31,71}

 
 

Good quality care (state of the art) {12,13,14}

 
 

Search for healthcare abroad in case of unequalities due to regionalism {32}

 
   

Provider

Right to "physical harm" in case of treatment and with the implicit understanding and consent of the patient. {15}

Information {92}

 

Right to charge

Data protection/ adequate use {21,22}

  

Provide state of the art quality

   

Payer

Decision of the contents (oft he screening program) based on HTA {32, 77}

responsibility of providing public health issues and the organization of the delivery {64,65,81}

 

Collect contributions (like social insurance or tax)

Provide quality at least according to appropriate market authorization (procurement)

  

Contract providers (national law)

  

provide follow up treatment in case of positive result (at least abroad; {76}

   

Others

Industry: healthcare marketing takes place and provides an own journal{91}

Industry: quality of the test;  market authorisation

 

EU: consumer protection issues

EU: Provide transparent market authorization processes

  

Reduced advertisement in health care {national status){88,89,90}

  

Appropriate protection of minors and incompetent persons {71,72,73}

 

Introduction

The legal aspects focus on the legal basics for crc screening, special requirements and specific groups in legislation.

Methodology

Frame

A modified collection scope is used in this domain.

TechnologyFecal Immunochemical Test (FIT) for colorectal cancer screening
Description

FITs use an antibody (immunoglobulin) specific to human globin, the protein component of haemoglobin, to detect fecal occult blood. Immunochemical tests have improved test characteristics compared to conventional guaiac-based tests for fecal occult blood. FIT should not be subject to interference from dietary blood and it is more specific to bleeding from the distal gastrointestinal tract. They could be analytically and clinically more sensitive and specific, Their measurement can be automated and the user can adjust the concentration at which a positive result is reported. A wide range of qualitative and quantitative tests is presently available, with varying levels of sensitivity and specificity (like Hem-SP/MagStream H, Fujirebio Inc. Japan ; OC-Sensor, Eiken Chemical Co., Tokyo, Japan;    FOB Gold, Medinostics Products Supplier; Sentinel Diagnostics SpA, Milan, Italy).

Intended use of the technologyScreening

CRC screening with faecal inmunochemical test (FIT) for detection of occult blood in the stool associated with colorectal lesions (adenomas and CRC).

The use of the test is considered under conditions of population based colorectal cancer screening, in the context of organised cancer screening programmes as recommended by the EU. Early detection and treatment of colorectal lesions before they become symptomatic has the potential to improve control of the disease, reducing morbidity and mortality associated to CRC. Early treatment of invasive lesions can be generally less detrimental for quality of life. The endoscopic removal of pre-malignant lesions also reduces the incidence of CRC by stopping the progression to cancer. Colorectal cancers and adenomatous polyps bleed has providing fecal blood haemoglobin as the biomarker of choice for current screening programmes. Stool samples could be periodically taken and analyzed for the presence of occult blood, as an early sign of colorectal lesions (adenoma or CRC).

Target condition
Adenomas, as non-malignant precursor lesions of ColoRectal Cancer (CRC).
Target condition description

CRC is the third most common in incidence and the fourth most common cause of cancer death worldwide. CRC is particularly suitable for screening. The disease is believed to develop in a vast majority of cases from non-malignant precursor lesions called adenomas. Adenomas can occur anywhere in the colorectum after a series of mutations that cause neoplasia of the epithelium. At some time , the adenoma may invade the submucosa and become malignant. Initially, this malignant cancer is not diagnosed and does not give symptoms  (preclinical phase). It can progress from localised (stage I) to metastasised (stage IV) cancer, until it causes symptoms and is diagnosed. Only 5–6% of the population actually develop CRC. The average duration of the development of an adenoma to CRC is estimated to be  at least 10 years. This long latent phase provides a window of opportunity for early detection of the disease.

Target population

Target population sex: Any. Target population age: adults and elderly. Target population group: Healthy and/or asymptomatic people.

Target population description

Adults, average risk of CRC, aged 50 years or over.

The best age range for offering gFOBT or FIT screening has not been investigated in trials. Circumstantial evidence suggests that mortality reduction from gFOBT is similar in different age ranges between 45 and 80 years .The age range for a national screening programme should at least include people aged 60 to 64 years in which CRC incidence and mortality are high and life-expectancy is still considerable. Only the FOBT for men and women aged 50–74 years has been recommended todate by the EU (Council Recommendation and the European guidelines for quality assurance in CRC screening and diagnosis).

Members of families with hereditary syndromes, previous diagnosis of CRC or pre-malignant lesions should follow specific surveillance protocols and are not included in the target population

ComparisonCRC screening with Guaiac –based fecal occult blood test (gFOBT)
Description

CRC screening with Guaiac–based fecal occult blood test (gFOBT)

The guaiac-based FOBT is still a commonly used method for detecting blood in faeces. To detect hemoglobin the test uses guaiac gum and its efficacy as a colorectal cancer screening test has been analyzed in several randomised controlled trials. The test detects the haem component of haemoglobin, which is identical across human and animal species and is chemically robust and only partially degraded during its passage through the gastrointestinal tract. gFOBTs cannot distinguish between human blood and blood residues from the diet.

Many guaiac-based tests are currently on the market (like Coloscreen, Helena Laboratories,Texas,USA; Hema-screen Immunostics Inc.; Hemoccult, Beckman Coulter Inc.; Hemoccult SENSA, Beckman Coulter Inc.; MonoHaem, Chemicon Europe Ltd; Hema-Check, Siemens PLC; HemaWipe, Medtek Diagnostics LLC)

The use of the test is considered under conditions of population based colorectal cancer screening, in the context of organised cancer screening programmes as recommended by the EU. Population-based programmes have been rolled out nationwide in several European countries. Many member states  haveestablished nationwide non-population-based programmes. Some states are planning or piloting a nationwide population-based programme. These have  adopted only FOBT, some only FIT, some a mix between FOBT and endoscopy, or only colonoscopy.

Outcomes

CUR and TEC

  • Health problems (target condition)
  • Epidemiology
  • Burden of disease
  • Target population
  • Current management of the condition
  • Features of the technology
  • Life-Cycle
  • Regulatory status
  • Utilization
  • Investments and tools required to use the technology
  • Training and information needed to use the technology

SAF

  • Colonoscopy probability of perforation
  • Colonoscopy with polypectomy probability of perforation
  • Colonoscopy probability of death following perforation
  • Probability of bleeding following colonoscopy
  • Psychological harms from false-negatives and false-positives (and generally from participating in screening program)

EFF

  • Test (FIT and gFOBT) sensitivity for adenomas
  • Test (FIT and gFOBT) sensitivity for cancer
  • Test (FIT and gFOBT) specificity for adenomas
  • Test (FIT and gFOBT) specificity for cancer 
  • Adenoma incidence (detection rates)
  • Rectal cancer incidence (detection rates)
  • Colon cancer incidence (detection rates)
  • CRC incidence (detection rates)
  • Stage distribution of detected cancers
  • Rectal cancer specific mortality
  • CRC specific mortality
  • Overall mortality
  • Life years saved

ECO:

  • Model/template for  national pilots  to assess the costs and benefits of the two alternative  technologies FIT and gFOBT  and also no-programmed-screening
  • Systematic literature search of   available models and/or economic  evaluation for screening colorectal cancer with FIT and gFOBT and no screening programme
  • Resource Utilization: Publicly funded health care payer costs (screening tests, further examinations e.g. labor, colonoscopy  and treatments and administration and organisation costs of screening programme) for FIT and gFOBT (in cooperation with ORG)
  • Cost per Case detected (average, marginal, incremental) =  intermediate outcome – optional, not decided yet (relevant for deciding how often a test should be carried out and what are the incremental costs for a “new” detected case
  • Indirect Costs: not for the Core modell (should be decided later on)
  • Test accuracy: from SAF
  • Cost effectiveness analysis: HRQoL measures (both generic and context specific) (EFF and SAF for help, own Lit.research), ICER

 ORG:

  • Responsiveness of target population to invitation
  • Invitation-reminder system
  • Competence of human resources – health professionals
  • Investments needed (material,equipment)
  • Costs of using both tests (FIT, gFOBT)
  • Timeliness of results and future phases
  • Use of tools for process monitoring (completed check lists)
  • Model for Budget Impact Analysis from perspective of the payer

SOC

  • Compliance with the tests (FIT, gFOBT)
  • Anxiety and any psychological effects of using  one test or another
  • Information, counseling, communication (quality of) for the use of tests
  • Satisfaction  
  • Quality of life
  • Equity of access

LEG

  • Information as baseline for an informed consent
  • Harms or inequities that can be taken to court
More information

If the PICO question is extended to other "modern" tests, especially including genetic analysis, we should ask whether there is a focus on detecting people at special risk rather than detecting crc in people with average risk.

The legal domain will definitely focus on terms of equity by defining average risk groups limited by certain age.

The general legal view for the network-use will focus on transborder healthcare (according to the directive which is to be implemented by 25th Oct 2013[1]. This includes the question whether it is the right of a person to get an (organized) screening or not and if yes, is this covered by the cross border healthcare directive?

[1] Directive 2011/24 of the European Parliament and of the Council on the application of patients' rights in cross-border healthcare. Commission of the European Communities (Articles 1 - 22). http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:088:0045:0065:EN:PDF

Assessment elements

TopicIssue RelevantResearch questions or rationale for irrelevance
I0002Autonomy of the patientIs the voluntary participation of patients guaranteed properly?yesIs the voluntary participation of patients guaranteed properly?
I0034Autonomy of the patientWho is allowed to give consent for minors and incompetent persons?yesWho is allowed to give consent for minors and incompetent persons?
I0036Autonomy of the patientDo laws/ binding rules require appropriate counseling and information to be given to the user or patient?yesDo laws/ binding rules require appropriate counseling and information to be given to the user or patient?
I0008Privacy of the patientDo laws/ binding rules require informing relatives about the results?yesDo laws/ binding rules require informing relatives about the results?
I0009Privacy of the patientDo laws/ binding rules require appropriate measures for securing patient data?yesDo laws/ binding rules require appropriate measures for securing patient data?
I0011Equality in health careDo laws/ binding rules require appropriate processes or resources to guarantee equal access to the technology?yesDo laws/ binding rules require appropriate processes or resources to guarantee equal access to FIT?
I0012Equality in health careIs the technology subsidized by the society?yesIs FIT subsidized by the society?
I0035Equality in health careDo laws/ binding rules require appropriate preventive or treatment measures available for all?yesDo laws/ binding rules require appropriate preventive or treatment measures available for all?
I0015Authorisation and safetyHas the technology national/EU level authorisation (marketing authorisation, registration, certification of safety, monitoring, qualification control, quality control)?yesHas the technology marketing authorisation?
I0019Ownership and liabilityDoes the technology infringe some intellectual property right?no The crc test does not have to be licensed for use - this is intended with the purchase.

Methodology description

Deviations from the project scope:

More information:

If the PICO question is extended to other "modern" tests, especially including genetic analysis, we should ask whether there is a focus on detecting people at special risk rather than detecting crc in people with average risk.

The legal domain will definitely focus on terms of equity by defining average risk groups limited by certain age.

The general legal view for the network-use will focus on transborder healthcare (according to the directive which is to be implemented by 25th Oct 2013{1}. This includes the question whether it is the right of a person to get an (organized) screening or not and if yes, is this covered by the cross border healthcare directive?

Information sources

Scientific research

Google search 22.03.2013 legals aspects for colorectal cancer screening (1 result)

Pubmed search on 22.03.2013 for "legislation and jurisprudence" [Subheading] AND "Jurisprudence"[Mesh] and colorectal cancer screening 14 results)

Pubmed search on 22.05.2013 for "cancer screening participation" (38 results)

Pubmed search for incompetent persons (2316 items)

Scan of the JA2/WP4 general search for crc, thematic elements "fit safety", "fit nuovo", "fit compliance" for elements of legal aspects

Inclusion of literature:

-          Legal relevance

-          Legal citation

-          Discussion of legal aspects

-          Main focus on EU relevant studies

Exclusion of literature:

-          Studies from other continents than Europe

-          Ethal discussion instead of legal discussion

-          No legal relevance for crc screening (like organ donation)

-          Genetic testing/ genetic aspects

Market authorization

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/testswaived.cfm?start_search=C (15.5.2013)

http://ec.europa.eu/consumers/sectors/medical-devices/market-surveillance-vigilance/eudamed/index_en.htm

legal background

EU and international law

http://europa.eu/about-eu/institutions-bodies/court-justice/index_de.htm for Patientendaten, Datenschutz

court decisions

EU court

http://eur-lex.europa.eu/

http://curia.europa.eu/juris/recherche.jsf?language=de – limitation to health sector, last 5 years – no results (3.5.2013)

http://conventions.coe.int/Treaty/EN/Treaties/Html/005.htm

Quality assessment tools or criteria

The literature research (medical sources) serves for basic aspects and discussion, it usually does not include legal rules. Therefore the evidence levels of the literature results and the quality of the literature are not assessed in this domain.

Peer Review was done by Gottfreid Endel, Hans Seyfried

Analysis and synthesis

Interpretation of the legal text/ papers/ court decisions according to the HTA questions.

Result cards

Autonomy of the patient

Result card for LEG1: "Is the voluntary participation of patients guaranteed properly?"

View full card
LEG1: Is the voluntary participation of patients guaranteed properly?
Result
Comment

Importance: Important

Transferability: Completely

Result card for LEG7: "Who is allowed to give consent for minors and incompetent persons?"

View full card
LEG7: Who is allowed to give consent for minors and incompetent persons?
Result
Comment

Importance: Critical

Transferability: Not

Result card for LEG9: "Do laws/ binding rules require appropriate counseling and information to be given to the user or patient?"

View full card
LEG9: Do laws/ binding rules require appropriate counseling and information to be given to the user or patient?
Result
Comment

Importance: Critical

Transferability: Completely

Privacy of the patient

Result card for LEG2: "Do laws/ binding rules require informing relatives about the results?"

View full card
LEG2: Do laws/ binding rules require informing relatives about the results?
Method
Frame
Result
Comment

Importance: Unspecified

Transferability: Unspecified

Result card for LEG3: "Do laws/ binding rules require appropriate measures for securing patient data?"

View full card
LEG3: Do laws/ binding rules require appropriate measures for securing patient data?
Method
Result
Comment

Importance: Important

Transferability: Completely

Equality in health care

Result card for LEG4: "Do laws/ binding rules require appropriate processes or resources to guarantee equal access to FIT?"

View full card
LEG4: Do laws/ binding rules require appropriate processes or resources to guarantee equal access to FIT?
Method
Result
Comment

Importance: Important

Transferability: Partially

Result card for LEG5: "Is FIT subsidized by the society?"

View full card
LEG5: Is FIT subsidized by the society?
Method
Result
Comment

Importance: Optional

Transferability: Partially

Result card for LEG8: "Do laws/ binding rules require appropriate preventive or treatment measures available for all?"

View full card
LEG8: Do laws/ binding rules require appropriate preventive or treatment measures available for all?
Method
Result
Comment

Importance: Important

Transferability: Partially

Authorisation and safety

Result card for LEG10: "Has the technology marketing authorisation?"

View full card
LEG10: Has the technology marketing authorisation?
Method
Result
Comment

Importance: Important

Transferability: Completely

Discussion

LEG1: Is the voluntary participation of patients guaranteed properly?

As long as there is no legal mandate for cancer prevention and treatment (register) and no other kind of forced screening participation which limits or exceeds the objective information the voluntary participation should be guaranteed.

LEG3: Do laws/ binding rules require appropriate measures for securing patient data?

There are clear regulations in data protection on EU level {21} and there is also an ongoing focus on the uptake of e-Health for providing better and safer healthcare due to the network use of information (data) without a clear regulation now.

LEG4: Do laws/ binding rules require appropriate processes or resources to guarantee equal access to FIT?

Limited access to Fit or gFOBT in screening programs for special (age) groups are based on the balance between evidence of best detection rates, economic calculations for the screening progam costs and reduction of possible disadvantages due to screening. A defined exclusion for people outside the groups for the screening program is not according to the law.

LEG5: Is FIT subsidized by the society?                                                                                   

There is a clear view and regulation at EU level for the responsibility of providing public health issues and the organization of the delivery of healthcare.Due to the fact that European countries have public healthcare systems the question of subsidization {amount) is a matter of HTA recommendations. Factors influencing screening participation on crc screening are gender, age, kind of invitation, risk communication, attitudes, social status, region of living, and kind of insurance coverage.

LEG6: Has FIT national/EU level authorisation {marketing authorisation, registration, certification of safety, monitoring, qualification control, quality control)?

There are several fecal occult blood tests registered by the FDA. European registration situation was not found for public access by the search.The market authorization has to be checked for the tests RPHA immudia, Alpha Wasserman, Alpha Wasserman Sentinel, and FlexSure OBT if used.

LEG7: Who is allowed to give consent for minors and incompetent persons?

The decision about minors is legally regulated to be provided by an authorized personal guardian. No clear legislation exists about the limits and refusal of healthcare. Court decisions about overcoming the guardian/ confirm the refusal by the guardian aim the best balance of benefit of the patient. In case of CRC screening it will affect the case of a positive screening result with the need of invasive examinations and cancer treatment procedure. This question should not be taken without the focus in the national legislation(s).

LEG8: Do laws/ binding rules require appropriate preventive or treatment measures available for all?

The test and/or treatment availability (colonoscopy after FIT or gFOBT, surgical treatment of detected crc, advanced therapy, etc.) should not threaten the European health care systems. In case of CRC a positive result requires a complex treatment strategy which is able to serve the epidemiological burden. The reimbursement by the national health system for necessary abroad treatment is court-decided by a case and recently regulated by the cross-border healthcare directive.

LEG9: Do laws/ binding rules require appropriate counseling and information to be given to the user or patient?

The need for information for the patient about benefits, harms and realistic expectations is known and legally regulated and the crucial element in an informed consent screening, including information about processes in case of a positive screening test {correct interpretation, following tests, proceeding to therapy).

Legal uncertainties occur in terms of responsibility for failed screening-expectations. Who is responsible for what kind of information, how should the informed consent be documented? Who is responsible to organize further processes in terms of a positive screeing result?

A degree of freedom seems to be for patients and their responsibility among offered screening. Do patients have to participate in a compliant way? (What, if not?) Does participation in a screeing program mean to agree in follow-up examinations/treatments?

For FIT and FOBT no transparent market authorization overview among the EU was found. There seems to be a need for consumer protection in terms of healthcare devices and advertisement for special products or services in order to guarantee the freedom of participation based on unbiased information.

References

[1] Directive 2011/24 of the European Parliament and of the Council on the application of patients' rights in cross-border healthcare. Commission of the European Communities {Articles 1 - 22). http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:088:0045:0065:EN:PDF

[2] A. Tupsela {2006) European Journal of Cancer Care 15, 257-266. When legal worlds collide: from research to treatment in hereditary cancer prevention

[3] Katicic M, Antoljak N, Kujundzic M, Stamenic V, Skoko Poljak D, Kramaric D, Stimac D, Strnad Pesikan M, Samija M, Ebling Z. Results of National Colorectal Cancer Screening Program in Croatia {2007-2011). World J Gastroenterol. 2012 Aug 28;18{32):4300-7. doi: 10.3748/wjg.v18.i32.4300.

[4] Denters MJ, Deutekom M, Bossuyt PM, Fockens P, Dekker E. A feces collection paper does not enhance participation in a fecal immunochemical test-based colorectal cancer screening program: randomized clinical trial. Eur J Cancer Prev. 2012 Nov 18.

[5] Le Breton J, Journy N, Attali C, Le Corvoisier P, Brixi Z, Bastuji-Garin S, Chevreul K. Improving participation in colorectal cancer screening: targets for action. Prev Med. 2012 Nov;55{5):488-92. doi: 10.1016/j.ypmed.2012.08.004. Epub 2012 Aug 21.

[6] Van Roosbroeck S, Hoeck S, Van Hal G. Population-based screening for colorectal cancer using an immunochemical faecal occult blood test: a comparison of two invitation strategies. Cancer Epidemiol. 2012 Oct;36{5):e317-24. doi: 10.1016/j.canep.2012.04.003. Epub 2012 May 5.

[7] van Roon AH, Goede SL, van Ballegooijen M, van Vuuren AJ, Looman CW, Biermann K, Reijerink JC, Mannetje H', van der Togt AC, Habbema JD, van Leerdam ME, Kuipers EJ. Random comparison of repeated faecal immunochemical testing at different intervals for population-based colorectal cancer screening. Gut. 2013 Mar;62{3):409-15. doi: 10.1136/gutjnl-2011-301583. Epub 2012 Mar 2.

[8] Libby G, Brewster DH, McClements PL, Carey FA, Black RJ, Birrell J, Fraser CG, Steele RJ. The impact of population-based faecal occult blood test screening on colorectal cancer mortality: a matched cohort study. Br J Cancer. 2012 Jul 10;107{2):255-9. doi: 10.1038/bjc.2012.277. Epub 2012 Jun 26.

[9] Portillo I, Idigoras I, Ojembarrena E, Arana E, Luis Hurtado J, Basurko R, Tapia M, Luz Pena M. [Lesions detected in a colorectal cancer screening program in the Basque Country: first round {2009-2011)]. Gastroenterol Hepatol. 2013 May;36{5):301-8. doi: 10.1016/j.gastrohep.2013.02.004. Epub 2013 Apr 22.

[10] Quintero E, Castells A, Bujanda L, Cubiella J, Salas D, Lanas A, Andreu M, Carballo F, Morillas JD, Hernandez C, Jover R, Montalvo I, Arenas J, Laredo E, Hernandez V, Iglesias F, Cid E, Zubizarreta R, Sala T, Ponce M, Andres M, Teruel G, Peris A, Roncales. Colonoscopy versus fecal immunochemical testing in colorectal-cancer screening. N Engl J Med. 2012 Feb 23;366{8):697-706. doi: 10.1056/NEJMoa1108895.

[11] Parente F, Boemo C, Ardizzoia A, Costa M, Carzaniga P, Ilardo A, Moretti R, Cremaschini M, Parente EM, Pirola ME. Outcomes and cost evaluation of the first two rounds of a colorectal cancer screening program based on immunochemical fecal occult blood test in northern Italy. Endoscopy. 2013 Jan;45{1):27-34. doi: 10.1055/s-0032-1325800. Epub 2012 Dec 19.

[12] International Covenant on Economic, Social and Cultural Rights {1966); Article 12; http://www.ohchr.org/EN/ProfessionalInterest/Pages/CESCR.aspx {2.5.2013)

[13] European Code of Social Security {Revised); Article 8 + Article 10; http://conventions.coe.int/treaty/en/Treaties/Html/139.htm {2.5.2013)

[14] A Declaration on the Promotion of Patients' Rights in Europe, WHO 1994; http://www.who.int/genomics/public/eu_declaration1994.pdf {2.5.2013)

[15] criminal law on national level;i.e. A: §§ 83–88 StGB {http://www.ris.bka.gv.at/Dokument.wxe?Abfrage=Bundesnormen&Dokumentnummer=NOR40124586) {2.5.2013); D: § 223-§ 231, § 340 StGB {http://dejure.org/gesetze/StGB/223.html) {2.5.2013); Pl: Dz.U. 1997 nr 88 poz. 553 - Kodeks karny {http://isap.sejm.gov.pl/DetailsServlet?id=WDU19970880553) {2.5.2013);

[16] http://conventions.coe.int/Treaty/EN/Treaties/Html/005.htm {14.5.2013)

[17] German Court, Bundesgerichtshof 2 StR 454/09) 25th June 2010; http://hudoc.echr.coe.int/sites/eng/pages/search.aspx?i=001-113680#{"itemid":["001-113680"]} {2.5.20139

Wet toetsing levensbeëindiging op verzoek en hulp bij zelfdoding http://www.st-ab.nl/wetten/0829_Wet_toetsing_levensbeeindiging_op_verzoek_en_hulp_bij_zelfdoding.htm {2.5.2013)

PROPOSITION DE LOI relative à l'euthanasie volontaire; http://www.senat.fr/leg/ppl10-031.html {2.5.2013)

La loi belge relative à l'euthanasie; http://www.ginsburgh.net/textes/Fin_che_si_compia.pdf {2.5.2013)

L'euthanasie et l'assistance au suicide | Loi du 16 mars 2009. Sommaire. Sommaire. Préface. 6. Questions/réponses sur la loi sur l'euthanasie. 9 et l' assistance; http://www.legilux.public.lu/leg/a/archives/2009/0046/a046.pdf {2.5.2013)

[18] Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health Purposes; Articles 1 - 22 and Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes; Articles 1 - 24; http://conventions.coe.int/treaty/en/treaties/html/203.htm {2.5.2013)

[19] Denters, M., et al. {2010). "Participation rate in a second round of fecal immunochemical test based screening decreases due to low response rates among previous non-responders and first-time invitees." Gastroenterology 138{5): S186.

[20] Osborne, J. M., et al. {2012). "Patterns of participation over multiple rounds of faecal immunochemical test-based screening for colorectal cancer." J. Gastroenterol. Hepatol. 27: 27.

[21] http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31995L0046:en:NOT {10.7.2013)

[22] http://europa.eu/rapid/press-release_IP-11-1589_en.htm {15.7.2013)

[23] http://europa.eu/rapid/press-release_IP-08-1075_en.htm

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Appendices

Table 1

influences on higher participation

influences on lower participation

female gender {42,43}

male gender {44,45,46}

awareness of risk {48,49}

younger age groups {44,46, 47,43}

participation by mail {42}

social deprivation {44}

recommendation from clinicians {49}

urban people {42}

social influence {49}

expected versus experienced burden {50,51}

inviting eligible individuals {52}

unpleasureness of the examination {53}

attitudes {54,55,51}

not having 100% coverage

for medical fees for a long-term disease {47},

expected value {53}

having consulted a medical specialist

in the last 12months {47}

living in a pilot district for CRC screening {47}

not smoking {47}

having a private additional insurance {47}

Anxiety, pain, and quality of life {56,51}

health insurance plan {43}

lack of abdominal complaints {51}

high eductaional level {57}

 

Physicians contribution {57}

 

opportunity for early diagnosis {58, 51}

 

acquiring certainty about CRC presence {51}

 

individuals offered faecal immunochemical tests {59}

 

follow-up by telephone {60,62}

 

invitation letter {61,62}

 

scheduled appointment {62}

 

Table 2

Country

Brand name of test

Czech Republic

Hemoccult

Denmark

Hemoccult II

France

Hemoccult

Italy

RPHA immudia

 

Alpha Wasserman

 

Hemoccult SENSA II

 

Alpha Wasserman, Sentinel

 

FlexSure OBT

Poland

Hema Screen

Spain

Hema Screen

 

Hemoccult

Switzerland

Hemoccult

United Kingdom

Hema Screen

Table 3

Test System Name

Document Number

Analyte Name

Analyte Specialty

Complexity

Effective Date

Device Classification Name

510{K) Number

Model

Device Name

Applicant

Contact

Regulation Number

Classification Product Code

Date Received

Decision Date

Decision

Classification Advisory Committee

Review Advisory Committee

statement

FDA Review

Type

Reviewed by Third Party

Expedited Review

Combination Product

Device Classification Name for X100047

hema screen ER

K102664

Fecal Occult Blood

General Chemistry

WAIVED

#######

reagent, occult blood20

K102664

HSER-50, HSER-100

HEMA SCREEN ER

IMMUNOSTICS, INC.

3505 sunset ave.

ocean, NJ 07712

 

richard m peoples

8,6E+08

KHE22

11/29/2010

01/28/2011

substantially equivalent {SE)

Hematology

Hematology

statement23

Decision Summary24

Special

No

No

No

 

Henry Schein OneStep+ iFOBT

K060463

Fecal Occult Blood

General Chemistry

WAIVED

#######

reagent, occult blood20

K060463

 

HEMA SCREEN SPECIFIC IFOBT

IMMUNOSTICS, INC.

3505 sunset ave.

ocean, NJ 07712

 

jeffrey fleishman

8,6E+08

KHE22

02/22/2006

#######

substantially equivalent - CLIA submission {CS)

Hematology

Hematology

statement23

Decision Summary24

Traditional

No

No

No

 

Healthcare Provider Direct OneStep Fecal Occult Blood {FOB) Screen Card Test

K063693

Fecal Occult Blood

General Chemistry

WAIVED

07/22/2008

reagent, occult blood20

K063693

 

FORSURE ONE STEP FECAL OCCULT BLOOD {FOB) SCREEN CARD TEST

NEW BAY BIORESEARCH CO. LTD.

3108 avenida olmeda

carlsbad, CA 92009

 

rodrigo berlie

8,6E+08

KHE22

12/14/2006

#######

substantially equivalent - CLIA submission {CS)

Hematology

Hematology

summary23

Decision Summary24

Traditional

No

No

No

 

HEMOCARE

K840527

Fecal Occult Blood

General Chemistry

WAIVED

02/23/2004

reagent, occult blood20

K840527

 

COLOTRAK OCCULT BLOOD TEST

BREIT LABORATORIES, INC.

    

8,6E+08

KHE22

#######

#######

substantially equivalent {SE)

Hematology

Hematology

  

Traditional

No

 

No

 

HELENA LABORATORIES COLOSCREEN-ES

K003359

Fecal Occult Blood

General Chemistry

WAIVED

12/13/2000

reagent, occult blood20

K003359

 

COLOSCREEN-ES

HELENA LABORATORIES

1530 lindbergh dr.

p.o. box 752

beaumont, TX 77704

pat franks

8,6E+08

KHE22

10/27/2000

11/27/2000

substantially equivalent {SE)

Hematology

Hematology

statement23

 

Traditional

No

No

No

 

BTNX Inc. Rapid Response Fecal Immunochemical Test {FIT)

K100031

Fecal Occult Blood

General Chemistry

WAIVED

#######

reagent, occult blood20

K100031

440-10

IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10

IND DIAGNOSTIC INC.

1629 fosters way

delta, bc,

 

jason peng

8,6E+08

KHE22

#######

07/19/2010

substantially equivalent - CLIA submission {CS)

Hematology

Hematology

statement23

Decision Summary24

Traditional

No

No

No

 

BTNX Inc. Rapid Response Immunological Fecal Occult Blood Test {IFOBT)

K061065

Fecal Occult Blood

General Chemistry

WAIVED

07/22/2008

reagent, occult blood20

K061065

 

FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25

TECO DIAGNOSTICS

1268 north lakeview ave.

anaheim, CA 92807

 

jian vaeches

8,6E+08

KHE22

04/17/2006

07/14/2006

substantially equivalent {SE)

Hematology

Hematology

summary23

Decision Summary24

Traditional

No

No

No

 

BECKMAN COULTER HEMOCCULT ICT

K080812

Fecal Occult Blood

General Chemistry

WAIVED

#######

reagent, occult blood20

K080812

 

HEMOCCULT ICT

BECKMAN COULTER, INC.

200 south kraemer blvd. w-110

po box 8000

brea, CA 92822

sylvia zorich

8,6E+08

KHE22

03/24/2008

06/25/2008

substantially equivalent - CLIA submission {CS)

Hematology

Hematology

summary23

Decision Summary24

Traditional

No

No

No

 

BTNX Inc. Clarity Fecal Occult Blood {FOB) Self Test

K070660

Fecal Occult Blood

General Chemistry

WAIVED

#######

reagent, occult blood20

K070660

 

INSTANT-VIEW FECAL OCCULT BLOOD {FOB) RAPID TEST

ALFA SCIENTIFIC DESIGNS, INC.

13200 gregg st.

poway, CA 92064

 

majid pajouh

8,6E+08

KHE22

03/13/2007

06/21/2007

substantially equivalent - CLIA submission {CS)

Hematology

Hematology

summary23

Decision Summary24

Traditional

No

No

No

 

BTNX Inc. Know Fecal Occult Blood {FOB) Self Test

K070660

Fecal Occult Blood

General Chemistry

WAIVED

#######

reagent, occult blood20

K070660

 

INSTANT-VIEW FECAL OCCULT BLOOD {FOB) RAPID TEST

ALFA SCIENTIFIC DESIGNS, INC.

13200 gregg st.

poway, CA 92064

 

majid pajouh

8,6E+08

KHE22

03/13/2007

06/21/2007

substantially equivalent - CLIA submission {CS)

Hematology

Hematology

summary23

Decision Summary24

Traditional

No

No

No

 

BTNX Inc. Rapid Response Fecal Occult Blood {FOB) Self Test

K070660

Fecal Occult Blood

General Chemistry

WAIVED

#######

reagent, occult blood20

K070660

 

INSTANT-VIEW FECAL OCCULT BLOOD {FOB) RAPID TEST

ALFA SCIENTIFIC DESIGNS, INC.

13200 gregg st.

poway, CA 92064

 

majid pajouh

8,6E+08

KHE22

03/13/2007

06/21/2007

substantially equivalent - CLIA submission {CS)

Hematology

Hematology

summary23

Decision Summary24

Traditional

No

No

No

 

BECKMAN COULTER HEMOCCULT ICT

K961062

Fecal Occult Blood

General Chemistry

WAIVED

06/28/2004

reagent, occult blood20

K961062

 

FLEXSURE OBT

SMITHKLINE DIAGNOSTICS, INC.

606 elmwood ave.

court iii

sharon hill, PA 19079 1031

marshall c mccarty

8,6E+08

KHE22

03/18/1996

#######

substantially equivalent {SE)

Hematology

Immunology

summary23

 

Traditional

No

No

No

 

BECKMAN COULTER HEMOCCULT ICT

K961062

Fecal Occult Blood

General Chemistry

WAIVED

05/26/2004

reagent, occult blood20

K961062

 

FLEXSURE OBT

SMITHKLINE DIAGNOSTICS, INC.

606 elmwood ave.

court iii

sharon hill, PA 19079 1031

marshall c mccarty

8,6E+08

KHE22

03/18/1996

#######

substantially equivalent {SE)

Hematology

Immunology

summary23

 

Traditional

No

No

No

 

BECKMAN COULTER PRIMARY CARE DIAGNOSTICS HEMOCCULT SENSA

K880499

Fecal Occult Blood

General Chemistry

WAIVED

#######

reagent, occult blood20

K880499

 

HEMOCCULT SENSITIVE TEST

SMITH KLINE DIAGNOSTICS, INC.

225 baypointe pkwy.

san jose, CA 95134 1622

 

ronald schoengold

8,6E+08

KHE22

#######

05/23/1988

substantially equivalent {SE)

Hematology

Hematology

  

Traditional

No

 

No

 

BERGEN BRUNSWIG TEST FOR FECAL OCCULT BLOOD

K911075

Fecal Occult Blood

General Chemistry

WAIVED

09/27/2001

reagent, occult blood20

K911075

 

COLOSCREEN

HELENA LABORATORIES

1530 lindbergh dr.

p.o. box 752

beaumont, TX 77704

pat franks

8,6E+08

KHE22

#######

#######

substantially equivalent {SE)

Hematology

Hematology

  

Traditional

No

 

No

 

Centralcheck iFOBT Complete Fecal Occult Blood Test

K063693

Fecal Occult Blood

General Chemistry

WAIVED

11/16/2010

reagent, occult blood20

K063693

 

FORSURE ONE STEP FECAL OCCULT BLOOD {FOB) SCREEN CARD TEST

NEW BAY BIORESEARCH CO. LTD.

3108 avenida olmeda

carlsbad, CA 92009

 

rodrigo berlie

8,6E+08

KHE22

12/14/2006

#######

substantially equivalent - CLIA submission {CS)

Hematology

Hematology

summary23

Decision Summary24

Traditional

No

No

No

 

Care Diagnostic Clarity IFOB Test

K052598

Fecal Occult Blood

General Chemistry

WAIVED

01/26/2010

reagent, occult blood20

K052598

 

IMMOCARE

CARE DIAGNOSTIC, INC.

1741 wiard street

klamath falls, OR 97603

 

araceli fancher-ferreira

8,6E+08

KHE22

09/21/2005

03/16/2006

substantially equivalent - CLIA submission {CS)

Hematology

Hematology

statement23

Decision Summary24

Traditional

No

No

No

 

CLIAwaived, Inc. Rapid Fecal Occult Blood Test

K061065

Fecal Occult Blood

General Chemistry

WAIVED

#######

reagent, occult blood20

K061065

 

FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25

TECO DIAGNOSTICS

1268 north lakeview ave.

anaheim, CA 92807

 

jian vaeches

8,6E+08

KHE22

04/17/2006

07/14/2006

substantially equivalent {SE)

Hematology

Hematology

summary23

Decision Summary24

Traditional

No

No

No

 

Care Fecal Occult Blood Test

K051806

Fecal Occult Blood

General Chemistry

WAIVED

#######

reagent, occult blood20

K051806

 

CARE FECAL OCCULT BLOOD TEST, MODEL KT313

EPITOPE DIAGNOSTICS, INC.

7955 dunbrook rd., suite b

san diego, CA 92126

 

ping gao

8,6E+08

KHE22

#######

#######

substantially equivalent {SE)

Hematology

Hematology

statement23

Decision Summary24

Traditional

No

No

No

 

Clarity Hemosure One-Step Immunological Fecal Occult Blood Test

K041202

Fecal Occult Blood

General Chemistry

WAIVED

03/30/2005

reagent, occult blood20

K041202

 

HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST

W.H.P.M., INC.

163 cabot st.

beverly, MA 01915

 

fran white

8,6E+08

KHE22

#######

#######

substantially equivalent - CLIA submission {CS)

Hematology

Hematology

summary23

Decision Summary24

Traditional

No

No

No

 

Clearview Ultra FOB Test

K041297

Fecal Occult Blood

General Chemistry

WAIVED

08/18/2004

reagent, occult blood20

K041297

 

POLYMEDCO OC LIGHT FOBT TEST

POLYMEDCO, INC.

510 furnace dock rd.

cortlandt manor, NY 10567

 

helen landicho

8,6E+08

KHE22

05/14/2004

#######

substantially equivalent - CLIA submission {CS)

Hematology

Hematology

statement23

Decision Summary24

Traditional

No

No

No

 

CHASMA SCIENTIFIC, INC., CHASMA-CULT {TRI-SLIDE AND SINGLE SLIDE STOOL}

K761232

Fecal Occult Blood

General Chemistry

WAIVED

06/28/2004

reagent, occult blood20

K761232

 

QUICK CULT SLIDE TEST FECAL OCCULT BLOOD

LABORATORY DIAGNOSTICS CO., INC.

    

8,6E+08

KHE22

#######

12/21/1976

substantially equivalent {SE)

Hematology

Hematology

  

Traditional

No

 

No

 

CHASMA SCIENTIFIC, INC., CHASMA-CULT {QUICK CULT SLIDE}

K761232

Fecal Occult Blood

General Chemistry

WAIVED

06/28/2004

reagent, occult blood20

K761232

 

QUICK CULT SLIDE TEST FECAL OCCULT BLOOD

LABORATORY DIAGNOSTICS CO., INC.

    

8,6E+08

KHE22

#######

12/21/1976

substantially equivalent {SE)

Hematology

Hematology

  

Traditional

No

 

No

 

CHEMICON MONOHAEM

K901064

Fecal Occult Blood

General Chemistry

WAIVED

05/15/2003

reagent, occult blood20

K901064

 

MONOHAEM {FECAL OCCULT BLOOD TEST)

SILENUS LABORATORIES PROPRIETARY LTD.

wilmington, DE 19897

  

william a best

8,6E+08

KHE22

#######

#######

substantially equivalent {SE)

Hematology

Hematology

  

Traditional

No

 

No

 

CIDA COLOCHECK

K911075

Fecal Occult Blood

General Chemistry

WAIVED

09/27/2001

reagent, occult blood20

K911075

 

COLOSCREEN

HELENA LABORATORIES

1530 lindbergh dr.

p.o. box 752

beaumont, TX 77704

pat franks

8,6E+08

KHE22

#######

#######

substantially equivalent {SE)

Hematology

Hematology

  

Traditional

No

 

No

 

DE HEALTHCARE PRODUCTS DETECT~OCCULT SLIDE TEST FOR FECAL OCCULT BLOOD

K902360

Fecal Occult Blood

General Chemistry

WAIVED

#######

reagent, occult blood20

K902360

 

HEMA-SCREEN

IMMUNOSTICS CO., INC.

3505 sunset ave.

ocean, NJ 07712

 

kenneth kupits

8,6E+08

KHE22

05/29/1990

07/27/1990

substantially equivalent {SE)

Hematology

Hematology

  

Traditional

No

 

No

 

DIAGNOSTICA, INC. EASE-A-CULT SENSITIVE

K002756

Fecal Occult Blood

General Chemistry

WAIVED

02/21/2001

reagent, occult blood20

K002756

 

EASE-A-CULT

DIAGNOSTICA, INC.

p.o. box 4341

crofton, MD 21114

 

yolanda smith

8,6E+08

KHE22

#######

02/23/2001

substantially equivalent {SE)

Hematology

Hematology

statement23

 

Traditional

No

No

No

 

ENTERIX INSURE II FECAL IMMUNOCHEMICAL TEST

K060930

Fecal Occult Blood

General Chemistry

WAIVED

#######

reagent, occult blood20

K060930

 

INSURE II

ENTERIX INC.

236 fernwood ave.

edison, NJ 08837

 

edwin diaz

8,6E+08

KHE22

#######

#######

substantially equivalent {SE)

Hematology

Hematology

statement23

Decision Summary24

Special

No

No

No

 

ENTERIX INSURE FECAL IMMUNOCHEMICAL TEST

K002457

Fecal Occult Blood

General Chemistry

WAIVED

10/16/2003

reagent, occult blood20

K002457

 

!NSURE FECAL OCCULT BLOOD TEST

ENTERIX INC.

348 us route one

falmouth,, ME 04105

 

robert c bruce

8,6E+08

KHE22

#######

#######

substantially equivalent {SE)

Hematology

Hematology

summary23

 

Traditional

No

No

No

 

ENTERIX !NSURE FECAL OCCULT BLOOD TEST

K002457

Fecal Occult Blood

General Chemistry

WAIVED

01/31/2001

reagent, occult blood20

K002457

 

!NSURE FECAL OCCULT BLOOD TEST

ENTERIX INC.

348 us route one

falmouth,, ME 04105

 

robert c bruce

8,6E+08

KHE22

#######

#######

substantially equivalent {SE)

Hematology

Hematology

summary23

 

Traditional

No

No

No

 

Forsure One Step Fecal Occult Blood {FOB) Screen Card Test

K063693

Fecal Occult Blood

General Chemistry

WAIVED

05/16/2007

reagent, occult blood20

K063693

 

FORSURE ONE STEP FECAL OCCULT BLOOD {FOB) SCREEN CARD TEST

NEW BAY BIORESEARCH CO. LTD.

3108 avenida olmeda

carlsbad, CA 92009

 

rodrigo berlie

8,6E+08

KHE22

12/14/2006

#######

substantially equivalent - CLIA submission {CS)

Hematology

Hematology

summary23

Decision Summary24

Traditional

No

No

No

 

FISHER HEALTHCARE SURE-VUE FECAL OCCULT BLOOD

K911075

Fecal Occult Blood

General Chemistry

WAIVED

09/27/2001

reagent, occult blood20

K911075

 

COLOSCREEN

HELENA LABORATORIES

1530 lindbergh dr.

p.o. box 752

beaumont, TX 77704

pat franks

8,6E+08

KHE22

#######

#######

substantially equivalent {SE)

Hematology

Hematology

  

Traditional

No

 

No

 

Germaine Laboratories Compliance Gold iFOB {immunological fecal occult blood)Test

K063693

Fecal Occult Blood

General Chemistry

WAIVED

#######

reagent, occult blood20

K063693

 

FORSURE ONE STEP FECAL OCCULT BLOOD {FOB) SCREEN CARD TEST

NEW BAY BIORESEARCH CO. LTD.

3108 avenida olmeda

carlsbad, CA 92009

 

rodrigo berlie

8,6E+08

KHE22

12/14/2006

#######

substantially equivalent - CLIA submission {CS)

Hematology

Hematology

summary23

Decision Summary24

Traditional

No

No

No

 

GERMAINE LABORATORIES AimStep Immunological Fecal Occult Blood Test {iFOBT)

K063693

Fecal Occult Blood

General Chemistry

WAIVED

#######

reagent, occult blood20

K063693

 

FORSURE ONE STEP FECAL OCCULT BLOOD {FOB) SCREEN CARD TEST

NEW BAY BIORESEARCH CO. LTD.

3108 avenida olmeda

carlsbad, CA 92009

 

rodrigo berlie

8,6E+08

KHE22

12/14/2006

#######

substantially equivalent - CLIA submission {CS)

Hematology

Hematology

summary23

Decision Summary24

Traditional

No

No

No

 

Immunostics, Inc., hema-screen STAT

K905782

Fecal Occult Blood

General Chemistry

WAIVED

05/20/2010

reagent, occult blood20

K905782

 

FHT {FECAL HEME TEST)

AERSCHER, INC.

527 fey rd.

chestertown, MD 21620

 

robert schreiber

8,6E+08

KHE22

12/21/1990

#######

substantially equivalent {SE)

Hematology

Hematology

  

Traditional

No

 

No

 

Inverness Medical Clearview iFOBT Complete Fecal Occult Blood Test

K063693

Fecal Occult Blood

General Chemistry

WAIVED

#######

reagent, occult blood20

K063693

 

FORSURE ONE STEP FECAL OCCULT BLOOD {FOB) SCREEN CARD TEST

NEW BAY BIORESEARCH CO. LTD.

3108 avenida olmeda

carlsbad, CA 92009

 

rodrigo berlie

8,6E+08

KHE22

12/14/2006

#######

substantially equivalent - CLIA submission {CS)

Hematology

Hematology

summary23

Decision Summary24

Traditional

No

No

No

 

Inverness Medical Clearview iFOBT Complete Fecal Occult Blood Test

K063693

Fecal Occult Blood

General Chemistry

WAIVED

#######

reagent, occult blood20

K063693

 

FORSURE ONE STEP FECAL OCCULT BLOOD {FOB) SCREEN CARD TEST

NEW BAY BIORESEARCH CO. LTD.

3108 avenida olmeda

carlsbad, CA 92009

 

rodrigo berlie

8,6E+08

KHE22

12/14/2006

#######

substantially equivalent - CLIA submission {CS)

Hematology

Hematology

summary23

Decision Summary24

Traditional

No

No

No

 

Innovacon FOB Flipcard Fecal Occult Blood Test

K063673

Fecal Occult Blood

General Chemistry

WAIVED

#######

reagent, occult blood20

K063673

 

INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE

INNOVACON, INC.

4106 sorrento valley blvd.

san diego, CA 92121

 

edward tung

8,6E+08

KHE22

#######

#######

substantially equivalent - CLIA submission {CS)

Hematology

Hematology

summary23

Decision Summary24

Traditional

No

No

No

 

InSure Quik Fecal Immunochemical Test {F.I.T.)

K060930

Fecal Occult Blood

General Chemistry

WAIVED

01/26/2007

reagent, occult blood20

K060930

 

INSURE II

ENTERIX INC.

236 fernwood ave.

edison, NJ 08837

 

edwin diaz

8,6E+08

KHE22

#######

#######

substantially equivalent {SE)

Hematology

Hematology

statement23

Decision Summary24

Special

No

No

No

 

Immunostics, Inc., hema-screen SPECIFIC Immunochemical Fecal Occult Blood Test

K060463

Fecal Occult Blood

General Chemistry

WAIVED

06/15/2006

reagent, occult blood20

K060463

 

HEMA SCREEN SPECIFIC IFOBT

IMMUNOSTICS, INC.

3505 sunset ave.

ocean, NJ 07712

 

jeffrey fleishman

8,6E+08

KHE22

02/22/2006

#######

substantially equivalent - CLIA submission {CS)

Hematology

Hematology

statement23

Decision Summary24

Traditional

No

No

No

 

immoCARE Fecal Occult Blood Test

K052598

Fecal Occult Blood

General Chemistry

WAIVED

03/22/2006

reagent, occult blood20

K052598

 

IMMOCARE

CARE DIAGNOSTIC, INC.

1741 wiard street

klamath falls, OR 97603

 

araceli fancher-ferreira

8,6E+08

KHE22

09/21/2005

03/16/2006

substantially equivalent - CLIA submission {CS)

Hematology

Hematology

statement23

Decision Summary24

Traditional

No

No

No

 

Jant Pharmacal Accutest Dual Sample Immunological Fecal Occult Blood {iFOB) Test

K073431

Fecal Occult Blood

General Chemistry

WAIVED

#######

reagent, occult blood20

K073431

 

FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE {FOR PROFESSIONAL AND HOME USE); {FOR PROFESSIONAL); {FOR HOME T

TIANJIN NEW BAY BIORESEARCH CO., LTD.

3108 avenida olmeda

carlsbad, CA 92009

 

armando torrescano

8,6E+08

KHE22

12/14/2007

01/14/2008

substantially equivalent - CLIA submission {CS)

Hematology

Hematology

 

Decision Summary23

Special

No

No

No

 

Jant Pharmacal Accutest Immunological Fecal Occult Blood Test {iFOBT)

K063693

Fecal Occult Blood

General Chemistry

WAIVED

#######

reagent, occult blood20

K063693

 

FORSURE ONE STEP FECAL OCCULT BLOOD {FOB) SCREEN CARD TEST

NEW BAY BIORESEARCH CO. LTD.

3108 avenida olmeda

carlsbad, CA 92009

 

rodrigo berlie

8,6E+08

KHE22

12/14/2006

#######

substantially equivalent - CLIA submission {CS)

Hematology

Hematology

summary23

Decision Summary24

Traditional

No

No

No

 

Medline iFOB One-Step Immunological Fecal Occult Blood Test

K100031

Fecal Occult Blood

General Chemistry

WAIVED

04/19/2012

reagent, occult blood20

K100031

440-10

IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10

IND DIAGNOSTIC INC.

1629 fosters way

delta, bc,

 

jason peng

8,6E+08

KHE22

#######

07/19/2010

substantially equivalent - CLIA submission {CS)

Hematology

Hematology

statement23

Decision Summary24

Traditional

No

No

No

 

MEDTEK DIAGNOSTICS INSTACCULT

K002930

Fecal Occult Blood

General Chemistry

WAIVED

01/30/2001

reagent, occult blood20

K002930

 

INSTACCULT

MEDTEK DIAGNOSTICS, LLC.

po box 14125

research triangle park, NC 27709 4125

 

liane f gosset

8,6E+08

KHE22

09/20/2000

01/22/2001

substantially equivalent {SE)

Hematology

Hematology

statement23

 

Traditional

No

No

No

 

OSOM® iFOB Test OSOM® iFOBT Control Kit

K121397

Fecal Occult Blood

General Chemistry

WAIVED

#######

reagent, occult blood20

K121397

PN 150, PN151, PN152, PN153

OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT

SEKISUI DIAGNOSTICS, LLC

6659 top gun st

san diego, CA 92121

 

mark stavro

8,6E+08

KHE22

#######

12/28/2012

substantially equivalent - CLIA submission {CS)

Hematology

Hematology

summary23

Decision Summary24

Traditional

No

No

No

 

Orient Gene Biotech - One Step Rapid FOB

K110309

Fecal Occult Blood

General Chemistry

WAIVED

09/20/2011

reagent, occult blood20

K110309

 

FOB ONE STEP RAPID TEST

ORIENT GENE BIOTECH

150 cherry lane rd

east stroudsburg, PA 18301

 

gary lehnus

8,6E+08

KHE22

#######

09/14/2011

substantially equivalent {SE)

Hematology

Hematology

summary23

Decision Summary24

Traditional

No

No

No

 

OC-Light iFOB Test

K041297

Fecal Occult Blood

General Chemistry

WAIVED

03/24/2011

reagent, occult blood20

K041297

 

POLYMEDCO OC LIGHT FOBT TEST

POLYMEDCO, INC.

510 furnace dock rd.

cortlandt manor, NY 10567

 

helen landicho

8,6E+08

KHE22

05/14/2004

#######

substantially equivalent - CLIA submission {CS)

Hematology

Hematology

statement23

Decision Summary24

Traditional

No

No

No

 

OcculTech Fecal Occult Blood Rapid Test

K060953

Fecal Occult Blood

General Chemistry

WAIVED

09/22/2006

reagent, occult blood20

K060953

 

OCCULTECH FECAL OCCULT BLOOD RAPID TEST

YD DIAGNOSTICS CORP.

4304 evergreen lane

suite 101

annandale, VA 22003

dusic kwak

8,6E+08

KHE22

#######

09/18/2006

substantially equivalent - CLIA submission {CS)

Hematology

Hematology

summary23

Decision Summary24

Traditional

No

No

No

 

PSS CONSULT Diagnostic Occult Blood Test

K911075

Fecal Occult Blood

General Chemistry

WAIVED

#######

reagent, occult blood20

K911075

 

COLOSCREEN

HELENA LABORATORIES

1530 lindbergh dr.

p.o. box 752

beaumont, TX 77704

pat franks

8,6E+08

KHE22

#######

#######

substantially equivalent {SE)

Hematology

Hematology

  

Traditional

No

 

No

 

PSS CONSULT diagnostics Occult Blood Test-ES

K003359

Fecal Occult Blood

General Chemistry

WAIVED

#######

reagent, occult blood20

K003359

 

COLOSCREEN-ES

HELENA LABORATORIES

1530 lindbergh dr.

p.o. box 752

beaumont, TX 77704

pat franks

8,6E+08

KHE22

10/27/2000

11/27/2000

substantially equivalent {SE)

Hematology

Hematology

statement23

 

Traditional

No

No

No

 

POLYMEDCO POLY STAT OC-LIGHT FOB TEST

K041297

Fecal Occult Blood

General Chemistry

WAIVED

08/18/2004

reagent, occult blood20

K041297

 

POLYMEDCO OC LIGHT FOBT TEST

POLYMEDCO, INC.

510 furnace dock rd.

cortlandt manor, NY 10567

 

helen landicho

8,6E+08

KHE22

05/14/2004

#######

substantially equivalent - CLIA submission {CS)

Hematology

Hematology

statement23

Decision Summary24

Traditional

No

No

No

 

PSS SELECT OCCULT BLOOD TEST

K911075

Fecal Occult Blood

General Chemistry

WAIVED

09/27/2001

reagent, occult blood20

K911075

 

COLOSCREEN

HELENA LABORATORIES

1530 lindbergh dr.

p.o. box 752

beaumont, TX 77704

pat franks

8,6E+08

KHE22

#######

#######

substantially equivalent {SE)

Hematology

Hematology

  

Traditional

No

 

No

 

QuickVue iFOB Test {Immunochemical Fecal Occult Blood) {Cassette)

K021423

Fecal Occult Blood

General Chemistry

WAIVED

#######

reagent, occult blood20

K021423

 

INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST

ALFA SCIENTIFIC DESIGNS, INC.

12330 stowe dr.

poway, CA 92064

 

naishu wang

8,6E+08

KHE22

#######

06/17/2002

substantially equivalent {SE)

Hematology

Hematology

summary23

 

Abbreviated

No

No

No

 

REDWOOD BIOTECH FECAL OCCULT BLOOD TEST

K902360

Fecal Occult Blood

General Chemistry

WAIVED

09/25/2003

reagent, occult blood20

K902360

 

HEMA-SCREEN

IMMUNOSTICS CO., INC.

3505 sunset ave.

ocean, NJ 07712

 

kenneth kupits

8,6E+08

KHE22

05/29/1990

07/27/1990

substantially equivalent {SE)

Hematology

Hematology

  

Traditional

No

 

No

 

Status iFOBT

K100817

Fecal Occult Blood

General Chemistry

WAIVED

10/19/2011

reagent, occult blood20

K100817

 

BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST

PRINCETON BIOMEDITECH CORP.

4242 u.s. rt. 1

monmouth junction, NJ 08852 1905

 

jemo kang, ph.d.

8,6E+08

KHE22

03/19/2010

#######

substantially equivalent - CLIA submission {CS)

Hematology

Hematology

 

Decision Summary23

Traditional

No

No

No

 

Siemens Hematest Reagent Tablets {Pre-amendment device)

X100047

Fecal Occult Blood

General Chemistry

WAIVED

12/17/2010

510{k) Exempt Database

X100047

 

Hematest Reagent Tablets

Siemens Healthcare Diagnostics Inc.

2 edgewater drive

norwood, MA 02062

 

sheila smith

8,6E+08

KHE

#######

12/17/2010

         

Reagent, Occult Blood20

STANBIO HEMA-SCREEN

K911075

Fecal Occult Blood

General Chemistry

WAIVED

09/27/2001

reagent, occult blood20

K911075

 

COLOSCREEN

HELENA LABORATORIES

1530 lindbergh dr.

p.o. box 752

beaumont, TX 77704

pat franks

8,6E+08

KHE22

#######

#######

substantially equivalent {SE)

Hematology

Hematology

  

Traditional

No

 

No

 

STARLINE COLOSCAN

K911075

Fecal Occult Blood

General Chemistry

WAIVED

09/27/2001

reagent, occult blood20

K911075

 

COLOSCREEN

HELENA LABORATORIES

1530 lindbergh dr.

p.o. box 752

beaumont, TX 77704

pat franks

8,6E+08

KHE22

#######

#######

substantially equivalent {SE)

Hematology

Hematology

  

Traditional

No

 

No

 

Tianjin New Bay Bioresearch Co., Ltd. ForeSure IFOB Dual-Sample Fecal Occult Blood Screen Card Test

K073431

Fecal Occult Blood

General Chemistry

WAIVED

02/22/2012

reagent, occult blood20

K073431

 

FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE {FOR PROFESSIONAL AND HOME USE); {FOR PROFESSIONAL); {FOR HOME T

TIANJIN NEW BAY BIORESEARCH CO., LTD.

3108 avenida olmeda

carlsbad, CA 92009

 

armando torrescano

8,6E+08

KHE22

12/14/2007

01/14/2008

substantially equivalent - CLIA submission {CS)

Hematology

Hematology

 

Decision Summary23

Special

No

No

No

 

Table 4

Total number of observed claims

Detected malpractice

Reasons for malpractice

leading factors that contributed to the errors

307 closed malpractice claims reviewed

181 claims {59%) involved diagnostic errors that harmed patients

failure to order an appropriate diagnostic test {100 of 181 [55%]

failures in judgment {143 of 181 [79%])

 

106 of 181 {59%) of these errors were associated with serious harm

failure to create a proper follow-up plan {81 of 181 [45%]

vigilance or memory {106 of 181 [59%])

 

55 of 181{30%) resulted in death

failure to obtain an adequate history or perform an adequate physical examination {76 of 181 [42%]

knowledge {86 of 181 [48%])

 

For 106 of 181 {59%) of the errors, cancer was the diagnosis involved {breast {44 claims [24%]) and colorectal {13 claims [7%]) cancer)

incorrect interpretation of diagnostic tests {67 of 181 [37%]

patient-related factors {84 of 181 [46%])

   

handoffs {36 of 181 [20%])

 

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