Reagent, Occult Blood
FDA product code KHE · Class II (moderate risk) · 21 CFR 864.6550 · Hematology
97510(k) clearances
0PMA approvals
19recalls
Manufacturers
- Helena Laboratories 12
- Immunostics Inc., 7
- Smithkline Diagnostics, Inc. 4
- Alfa Scientific Designs, Inc. 3
- Enterix, Inc. 3
- Propper Mfg. Co., Inc. 3
- Aerscher Diagnostics 3
- Self Care Systems, Inc. 2
- Intl. Immunoassay Laboratories, Inc. 2
- Medtech Products, Inc. 2
- Breit Laboratories, Inc. 2
- Labeltape Meditect, Inc. 2
- Syn-Kit, Inc. 2
- Gamma Biologicals, Inc. 2
- Cambridge Chemical Products, Inc. 2
- Beta Med Pharmaceuticals, Inc. 1
- Guangzhou Wondfo Biotech Co., Ltd. 1
- Bio-Chem Laboratories 1
- C.B. Fleet Co., Inc. 1
- Otto C. Watzka 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K173212 | Instant-view-PLUS immunochemical Fecal Occult Blood TestKHE · Traditional | Alfa Scientific Designs, Inc. | 02/15/2018SE |
| K170548 | InSure ONEKHE · Traditional | Enterix, Inc. | 10/05/2017SE |
| K171484 | hema-screen SPECIFIC GoldKHE · Special | Immunostics Inc., | 06/14/2017SE |
| K162333 | Wondfo One Step Fecal Occult Blood (FOB) TestKHE · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 05/14/2017SE |
| K163554 | hema-screen ER XCEL Enhanced Readability Fecal Occult Blood TestKHE · Special | Immunostics Inc., | 01/17/2017SE |
| K143325 | OC-Light S FITKHE · Traditional | Eiken Chemical Co., Ltd. | 08/20/2015SE |
| K121397 | Osom Ifob 25 Test and Patient Collection Kit Osom Ifob Control Kit Osom Ifob 50 Test KitKHE · Traditional | SEKISUI Diagnostics, LLC | 12/28/2012SE |
| K113506 | Ind One Step Occult Blood (Fob) TestKHE · Special | Ind Diagnostics, Inc. | 12/19/2012SE |
| K110309 | Fob One Step Rapid TestKHE · Traditional | Orient Gene Biotech | 09/14/2011SE |
| K102664 | Hema Screen ErKHE · Special | Immunostics Inc., | 01/28/2011SE |
| K100031 | Ind One Step Fecal Occult Blood Test Model 440-10KHE · Traditional | Ind Diagnostic, Inc. | 07/19/2010SE |
| K100817 | Biosign Ifobtest, Biosign Fecal Occult Blood TestKHE · Traditional | Princeton BioMeditech Corp. | 07/01/2010SE |
| K080812 | Hemoccult IctKHE · Traditional | Beckman Coulter, Inc. | 06/25/2008SE |
| K071242 | Dbest One Step Occult Blood Test KitsKHE · Traditional | Ameritek USA, Inc. | 03/06/2008SE |
| K073431 | Forsure Ifob Duel Sample Fecal Occult Blood Test Device (for Professional and Home Use)…KHE · Special | Tianjin New Bay Bioresearch Co., Ltd. | 01/14/2008SE |
| K070660 | Instant-View Fecal Occult Blood (Fob) Rapid TestKHE · Traditional | Alfa Scientific Designs, Inc. | 06/21/2007SE |
| K063693 | Forsure One Step Fecal Occult Blood (Fob) Screen Card TestKHE · Traditional | New Bay Bioresearch Co. , Ltd. | 05/11/2007SE |
| K063673 | Innovacon Flipcard Fecal Occult Blood Test DeviceKHE · Traditional | Innovacon, Inc. | 03/05/2007SE |
| K060953 | Occultech Fecal Occult Blood Rapid TestKHE · Traditional | Yd Diagnostics Corp. | 09/18/2006SE |
| K061065 | Fecal Occult Blood Card Test, Model F735-A, Fecal Occult Blood Card Kit, Model F735-25KHE · Traditional | Teco Diagnostics | 07/14/2006SE |
| K060463 | Hema Screen Specific IfobtKHE · Traditional | Immunostics Inc., | 06/06/2006SE |
| K060930 | Insure IIKHE · Special | Enterix, Inc. | 05/04/2006SE |
| K052598 | ImmocareKHE · Traditional | Care Diagnostic, Inc. | 03/16/2006SE |
| K051806 | Care Fecal Occult Blood Test, Model KT313KHE · Traditional | Epitope Diagnostics, Inc. | 10/03/2005SE |
| K041297 | Polymedco Oc Light Fobt TestKHE · Traditional | Polymedco, Inc. | 08/12/2004SE |
| K041202 | Hemosure One-Step Fecal Occult Blood TestKHE · Traditional | W.H.P.M., Inc. | 08/12/2004SE |
| K033548 | Roche Diagnostics Urisys 1100 Urine AnalyzerKHE · Special | Roche Diagnostics Corp. | 11/24/2003SE |
| K031356 | Hemaprompt GastricKHE · Traditional | Aerscher Diagnostics | 09/24/2003SE |
| K030216 | ColoncareKHE · Traditional | Care Products, Inc. | 04/02/2003SE |
| K022755 | LifeguardKHE · Traditional | Medtek, LLC | 09/24/2002SE |
| K021423 | Instant-View Fecal Occult Blood Rapid TestKHE · Abbreviated | Alfa Scientific Designs, Inc. | 06/17/2002SE |
| K002756 | Ease-A-CultKHE · Traditional | Diagnostica, Inc. | 02/23/2001SE |
| K002930 | InstaccultKHE · Traditional | Medtek Diagnostics, LLC | 01/22/2001SE |
| K002457 | !Nsure Fecal Occult Blood TestKHE · Traditional | Enterix, Inc. | 01/12/2001SE |
| K003359 | Coloscreen-EsKHE · Traditional | Helena Laboratories | 11/27/2000SE |
| K992759 | Colon Alert TestKHE · Traditional | Immunostics Inc., | 12/06/1999SE |
| K984269 | Dbest Occult Blood Test KitKHE · Traditional | Ameritek, Inc. | 05/11/1999SE |
| K981661 | HemapromptKHE · Traditional | Aerscher Diagnostics | 09/15/1998SE |
| K980671 | Coloscreen-EsKHE · Traditional | Helena Laboratories | 05/12/1998SE |
| K972763 | HemapromptKHE · Traditional | Aerscher Diagnostics | 10/20/1997SE |
| K961062 | Flexsure ObtKHE · Traditional | Smithkline Diagnostics, Inc. | 11/06/1996SE |
| K936056 | Hemdetect(R) Test for Occult Blood in FecesKHE · Traditional | Dipro Diagnostic Products GmbH | 04/05/1995SE |
| K921798 | Propper Super Seracult(R)KHE · Traditional | Propper Mfg. Co., Inc. | 10/05/1992SE |
| K913622 | HemoplusKHE · Traditional | Sarstedt, Inc. | 01/31/1992SE |
| K912979 | Hemawipe System, the Civilized Test, ModificationKHE · Traditional | Labeltape Meditect, Inc. | 10/04/1991SE |
| K911075 | ColoscreenKHE · Traditional | Helena Laboratories | 07/03/1991SE |
| K905798 | ColocareKHE · Traditional | Helena Laboratories | 07/03/1991SE |
| K905782 | FHT (Fecal Heme Test)KHE · Traditional | Aerscher, Inc. | 05/06/1991SE |
| K901064 | Monohaem (Fecal Occult Blood Test)KHE · Traditional | Silenus Laboratories Proprietary , Ltd. | 11/05/1990SE |
| K902360 | Hema-ScreenKHE · Traditional | Immunostics Co., Inc. | 07/27/1990SE |
| K896474 | Resubmitted Fecatwin Sensitive - Feca-EiaKHE · Traditional | Labsystems, Inc. | 01/25/1990SE |
| K884206 | Hemawipe System, the Civilized TestKHE · Traditional | Labeltape Meditect, Inc. | 04/18/1989SE |
| K883432 | Immunoccult-LxiKHE · Traditional | Intl. Immunoassay Laboratories, Inc. | 10/31/1988SE |
| K882799 | Helena ColocareKHE · Traditional | Helena Laboratories | 09/30/1988SE |
| K874180 | Colorectal Cancer Risk Detector (TM)KHE · Traditional | Pearce Clinical Laboratories, Inc. | 09/30/1988SE |
| K881907 | Hemagel(Tm) Test for Fecal Occult BloodKHE · Traditional | Enzo Biochem, Inc. | 07/08/1988SE |
| K871143 | Immunoccult Eia Test KitKHE · Traditional | Intl. Immunoassay Laboratories, Inc. | 07/08/1988SE |
| K880499 | Hemoccult Sensitive TestKHE · Traditional | Smithkline Diagnostics, Inc. | 05/23/1988SE |
| K874482 | Revised Immudia Hem-SpKHE · Traditional | Schiff & Co. | 05/13/1988SE |
| K873409 | Wako(Tm) Pretest 6AKHE · Traditional | Wako Chemicals USA, Inc. | 02/11/1988SE |
| K862849 | Hemoccult Wipe TestKHE · Traditional | Smithkline Diagnostics, Inc. | 12/09/1986SE |
| K861731 | Natural Detector SystemKHE · Traditional | U.S. Health Resources Corp. | 11/06/1986SE |
| K855237 | Biotel (Tm)/ KidneyKHE · Traditional | American Diagnostic Corp. | 05/06/1986SE |
| K854358 | Ez Detech-Urine Blood Test SticksKHE · Traditional | Self Care Systems, Inc. | 04/09/1986SE |
| K860028 | Modified Ez Detect Occult Blood Test in StoolKHE · Traditional | Self Care Systems, Inc. | 04/07/1986SE |
| K854619 | DetectacultKHE · Traditional | Immunostics Co., Inc. | 03/03/1986SE |
| K853141 | Access Digiwipe SystemKHE · Traditional | Medtech Products, Inc. | 11/18/1985SE |
| K850431 | Ez-Detect Visual Color Test for Blood in StoolKHE · Traditional | Nms Pharmaceuticals, Inc. | 06/17/1985SE |
| K843601 | Access HemawipeKHE · Traditional | Medtech Products, Inc. | 01/04/1985SE |
| K843532 | Uropaper Eiken 8KHE · Traditional | Syn-Kit, Inc. | 12/12/1984SE |
| K843352 | Coloscreen Self-TestKHE · Traditional | Helena Laboratories | 12/05/1984SE |
| K842137 | Occult Blood TestKHE · Traditional | Breit Laboratories, Inc. | 09/05/1984SE |
| K840527 | Colotrak Occult Blood TestKHE · Traditional | Breit Laboratories, Inc. | 09/05/1984SE |
| K840904 | Accu-Cult Fecal Occult Blood TestKHE · Traditional | Applied Medical Devices, Inc. | 08/16/1984SE |
| K840903 | Helena Coloscreen Self-TestKHE · Traditional | Helena Laboratories | 08/10/1984SE |
| K833369 | Early DetectorKHE · Traditional | Warner-Lambert Co. | 08/02/1984SE |
| K832311 | Hemoccult-CKHE · Traditional | Menley & James Laboratories | 02/27/1984SE |
| K834297 | Propper SeracultKHE · Traditional | Propper Mfg. Co., Inc. | 01/27/1984SE |
| K834456 | Helena Bio Strip ObKHE · Traditional | Helena Laboratories | 01/13/1984SE |
| K832864 | Coloscreen V.P.I.KHE · Traditional | Helena Laboratories | 11/21/1983SE |
| K830919 | Occult-AlertKHE · Traditional | Beta Med Pharmaceuticals, Inc. | 07/07/1983SE |
| K830223 | Fecal Occult Slide Test KitKHE · Traditional | Cambridge Chemical Products, Inc. | 03/07/1983SE |
| K822731 | HemotectKHE · Traditional | Bio-Chem Laboratories | 10/18/1982SE |
| K821884 | Gastroccult TMKHE · Traditional | Smithkline Diagnostics, Inc. | 10/08/1982SE |
| K812728 | Fleet DetectatestKHE · Traditional | C.B. Fleet Co., Inc. | 07/02/1982SE |
| K820072 | Fe-Cult PlusKHE · Traditional | Gamma Biologicals, Inc. | 03/04/1982SE |
| K813204 | Seracult Occult Bloof TestKHE · Traditional | Propper Mfg. Co., Inc. | 01/28/1982SE |
| K811815 | Uropaper EikegKHE · Traditional | Syn-Kit, Inc. | 12/10/1981SE |
| K811752 | Fe-Cult PlusKHE · Traditional | Gamma Biologicals, Inc. | 11/02/1981SE |
| K812428 | Helena Coloscreen MethodKHE · Traditional | Helena Laboratories | 10/23/1981SE |
| K810488 | Home Health Chekup KitKHE · Traditional | Healthkit | 05/08/1981SE |
| K800433 | Helena ColocheckKHE · Traditional | Helena Laboratories | 05/02/1980SE |
| K792655 | Helena ColoscreenKHE · Traditional | Helena Laboratories | 01/24/1980SE |
| K780564 | FecatestKHE · Traditional | Otto C. Watzka | 06/30/1978SE |
| K780214 | Hemo FecKHE · Traditional | Boehringer Mannheim Corp. | 05/03/1978SE |
| K770153 | Camco R Pak-GuaiacKHE · Traditional | Cambridge Chemical Products, Inc. | 02/08/1977SE |
| K761232 | Quick Cult Slide Test Fecal Occult BloodKHE · Traditional | Laboratory Diagnostics Co., Inc. | 12/21/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0736-2026 Class II | Fecal Occult Blood TestDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0725-2026 Class II | InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit…InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false… | Enterix, Inc. | 09/17/2025Open, Classified |
| Z-1601-2022 Class II | a. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit Consult Colorectal Cancer Screening…Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-0590-2021 Class II | InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively…Product does not meet internal testing criterion; use of the product may result in a potential false… | Enterix, Inc. | 10/08/2020Terminated |
| Z-1080-2019 Class III | McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers…Products were denied Clinical Laboratory Improvement Amendments (CLIA) waiver approval by the FDA, due to… | Cypress Medical Products LLC | 02/27/2019Terminated |
| Z-0301-2019 Class II | Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The…Limits of Detection (LoD) for protein, nitrite, leukocytes, and erythrocytes on the Urisys 1100 urine… | Roche Diagnostics Corporation | 09/24/2018Terminated |
| Z-1950-2019 Class II | ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The…The positive control on some tests of the lots did not appropriately react within the specified timeframe to… | Helena Laboratories, Corp. | 08/08/2018Open, Classified |
| Z-1949-2019 Class II | ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The…The positive control on some tests of the lots did not appropriately react within the specified timeframe to… | Helena Laboratories, Corp. | 08/08/2018Open, Classified |
| Z-1997-2013 Class II | Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read…Beckman Coulter has received a customer complaint that suggests trending of positive results has increased… | Beckman Coulter Inc. | 07/17/2013Terminated |
| Z-2197-2013 Class II | Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides…The products may have been stored at temperatures outside their required storage conditions. | Assuramed | 07/16/2013Terminated |
| Z-1060-2013 Class II | Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the…The test strips in the affected product lots of the OC Light immunological fecal occult blood test are being… | Polymedco, Inc | 02/12/2013Terminated |
| Z-1059-2013 Class II | Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid…The test strips in the affected product lots of the OC Light immunological fecal occult blood test are being… | Polymedco, Inc | 02/12/2013Terminated |
| Z-2111-2011 | Clearview iFOB, Clearview - Clearview iFOB Return Mailer(accessory) Product Part Number:…Potential for false negatives test results and negative/faint positive controls | Alere North Americal | 03/21/2011Terminated |
| Z-2110-2011 | Clearview iFOB, Clearview - Clearview iFOB Specimen Collection (accessory) Product Part…Potential for false negatives test results and negative/faint positive controls | Alere North Americal | 03/21/2011Terminated |
| Z-2109-2011 | Clearview iFOB, Clearview - Clearview iFOB Test Cassettes (50 Test) Immunochemical Fecal…Potential for false negatives test results and negative/faint positive controls | Alere North Americal | 03/21/2011Terminated |
| Z-2108-2011 | Clearview iFOB, Clearview - Clearview iFOB Test Cassettes (25 Test) Immunochemical Fecal…Potential for false negatives test results and negative/faint positive controls | Alere North Americal | 03/21/2011Terminated |
| Z-2107-2011 | Clearview iFOB, Clearview - Sample Kit (5 Test)Immunochemical Fecal Occult Blood…Potential for false negatives test results and negative/faint positive controls | Alere North Americal | 03/21/2011Terminated |
| Z-2106-2011 | Clearview iFOB, Clearview iFOB Complete- Immunochemical Fecal Occult Blood Cassette Test…Potential for false negatives test results and negative/faint positive controls | Alere North Americal | 03/21/2011Terminated |
| Z-0480-2009 | INSURE(R) QUIK FIT(TM) DEVELOPER KIT, Lot number B1478, Product Numbers: 30025 (InSure…False readings: Reduced sensitivity could affect the test line area and/or control line on the test strips… | Enterix, Inc. | 10/03/2008Terminated |