Product Code: KHE
FDA class 2
21 CFR 864.6550
Reagent, Occult Blood
Hematology
Occult Blood Reagent is an in vitro diagnostic device used to detect the presence of hidden (occult) blood in patient samples such as stool, gastric aspirates, or other body fluids, serving as a screening tool for gastrointestinal bleeding and related conditions. It is classified as FDA Class 2, indicating moderate risk; devices in this category are subject to general controls and special controls, and typically require 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is KHE, regulated under 21 CFR 864.6550, within the Hematology medical specialty. This device is eligible for third-party review.
510(k)s
97
FEI Numbers
64
Registration Numbers
64
Unique Applicants
66
Years Active
41
Basic Information
- Product Code
- KHE
- Device Class
- FDA class 2
- Regulation Number
- 864.6550
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 97 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K173212 | Instant-view-PLUS immunochemical Fecal Occult Blood Test | Feb 15, 2018 | Substantially Equivalent | Alfa Scientific Designs, Inc. |
| K170548 | InSure ONE | Oct 05, 2017 | Substantially Equivalent | Enterix Inc. |
| K171484 | hema-screen SPECIFIC Gold | Jun 14, 2017 | Substantially Equivalent | Immunostics, Inc. |
| K162333 | Wondfo One Step Fecal Occult Blood (FOB) Test | May 14, 2017 | Substantially Equivalent | GUANGZHOU WONDFO BIOTECH CO., LTD. |
| K163554 | hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test | Jan 17, 2017 | Substantially Equivalent | Immunostics, Inc. |
| K143325 | OC-Light S FIT | Aug 20, 2015 | Substantially Equivalent | EIKEN CHEMICAL CO. LTD |
| K121397 | OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT | Dec 28, 2012 | Substantially Equivalent | SEKISUI DIAGNOSTICS, LLC |
| K113506 | IND ONE STEP OCCULT BLOOD (FOB) TEST | Dec 19, 2012 | Substantially Equivalent | IND DIAGNOSTICS INC. |
| K110309 | FOB ONE STEP RAPID TEST | Sep 14, 2011 | Substantially Equivalent | ORIENT GENE BIOTECH |
| K102664 | HEMA SCREEN ER | Jan 28, 2011 | Substantially Equivalent | IMMUNOSTICS, INC. |
| K100031 | IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 | Jul 19, 2010 | Substantially Equivalent | IND DIAGNOSTIC INC. |
| K100817 | BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST | Jul 01, 2010 | Substantially Equivalent | PRINCETON BIOMEDITECH CORP. |
| K080812 | HEMOCCULT ICT | Jun 25, 2008 | Substantially Equivalent | BECKMAN COULTER, INC. |
| K071242 | DBEST ONE STEP OCCULT BLOOD TEST KITS | Mar 06, 2008 | Substantially Equivalent | AMERITEK USA, INC. |
| K073431 | FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T | Jan 14, 2008 | Substantially Equivalent | Tianjin New Bay Bioresearch Co., Ltd. |
| K070660 | INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST | Jun 21, 2007 | Substantially Equivalent | ALFA SCIENTIFIC DESIGNS, INC. |
| K063693 | FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST | May 11, 2007 | Substantially Equivalent | NEW BAY BIORESEARCH CO. LTD. |
| K063673 | INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE | Mar 05, 2007 | Substantially Equivalent | INNOVACON, INC. |
| K060953 | OCCULTECH FECAL OCCULT BLOOD RAPID TEST | Sep 18, 2006 | Substantially Equivalent | YD DIAGNOSTICS CORP. |
| K061065 | FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25 | Jul 14, 2006 | Substantially Equivalent | TECO DIAGNOSTICS |
| K060463 | HEMA SCREEN SPECIFIC IFOBT | Jun 06, 2006 | Substantially Equivalent | IMMUNOSTICS, INC. |
| K060930 | INSURE II | May 04, 2006 | Substantially Equivalent | ENTERIX INC. |
| K052598 | IMMOCARE | Mar 16, 2006 | Substantially Equivalent | CARE DIAGNOSTIC, INC. |
| K051806 | CARE FECAL OCCULT BLOOD TEST, MODEL KT313 | Oct 03, 2005 | Substantially Equivalent | EPITOPE DIAGNOSTICS, INC. |
| K041297 | POLYMEDCO OC LIGHT FOBT TEST | Aug 12, 2004 | Substantially Equivalent | POLYMEDCO, INC. |
| K041202 | HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST | Aug 12, 2004 | Substantially Equivalent | W.H.P.M., INC. |
| K033548 | ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER | Nov 24, 2003 | Substantially Equivalent | ROCHE DIAGNOSTICS CORP. |
| K031356 | HEMAPROMPT GASTRIC | Sep 24, 2003 | Substantially Equivalent | AERSCHER DIAGNOSTICS |
| K030216 | COLONCARE | Apr 02, 2003 | Substantially Equivalent | CARE PRODUCTS, INC. |
| K022755 | LIFEGUARD | Sep 24, 2002 | Substantially Equivalent | MEDTEK LLC. |
| K021423 | INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST | Jun 17, 2002 | Substantially Equivalent | ALFA SCIENTIFIC DESIGNS, INC. |
| K002756 | EASE-A-CULT | Feb 23, 2001 | Substantially Equivalent | DIAGNOSTICA, INC. |
| K002930 | INSTACCULT | Jan 22, 2001 | Substantially Equivalent | MEDTEK DIAGNOSTICS, LLC. |
| K002457 | !NSURE FECAL OCCULT BLOOD TEST | Jan 12, 2001 | Substantially Equivalent | ENTERIX INC. |
| K003359 | COLOSCREEN-ES | Nov 27, 2000 | Substantially Equivalent | HELENA LABORATORIES |
| K992759 | COLON ALERT TEST | Dec 06, 1999 | Substantially Equivalent | IMMUNOSTICS, INC. |
| K984269 | DBEST OCCULT BLOOD TEST KIT | May 11, 1999 | Substantially Equivalent | AMERITEK, INC. |
| K981661 | HEMAPROMPT | Sep 15, 1998 | Substantially Equivalent | AERSCHER DIAGNOSTICS |
| K980671 | COLOSCREEN-ES | May 12, 1998 | Substantially Equivalent | HELENA LABORATORIES |
| K972763 | HEMAPROMPT | Oct 20, 1997 | Substantially Equivalent | AERSCHER DIAGNOSTICS |
| K961062 | FLEXSURE OBT | Nov 06, 1996 | Substantially Equivalent | SMITHKLINE DIAGNOSTICS, INC. |
| K936056 | HEMDETECT(R) TEST FOR OCCULT BLOOD IN FECES | Apr 05, 1995 | Substantially Equivalent | DIPRO DIAGNOSTIC PRODUCTS GMBH |
| K921798 | PROPPER SUPER SERACULT(R) | Oct 05, 1992 | Substantially Equivalent | PROPPER MFG. CO., INC. |
| K913622 | HEMOPLUS | Jan 31, 1992 | Substantially Equivalent | SARSTEDT, INC. |
| K912979 | HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION | Oct 04, 1991 | Substantially Equivalent | LABELTAPE MEDITECT, INC. |
| K911075 | COLOSCREEN | Jul 03, 1991 | Substantially Equivalent | HELENA LABORATORIES |
| K905798 | COLOCARE | Jul 03, 1991 | Substantially Equivalent | HELENA LABORATORIES |
| K905782 | FHT (FECAL HEME TEST) | May 06, 1991 | Substantially Equivalent | AERSCHER, INC. |
| K901064 | MONOHAEM (FECAL OCCULT BLOOD TEST) | Nov 05, 1990 | Substantially Equivalent | SILENUS LABORATORIES PROPRIETARY LTD. |
| K902360 | HEMA-SCREEN | Jul 27, 1990 | Substantially Equivalent | IMMUNOSTICS CO., INC. |
| K896474 | RESUBMITTED FECATWIN SENSITIVE - FECA-EIA | Jan 25, 1990 | Substantially Equivalent | LABSYSTEMS, INC. |
| K884206 | HEMAWIPE SYSTEM, THE CIVILIZED TEST | Apr 18, 1989 | Substantially Equivalent | LABELTAPE MEDITECT, INC. |
| K883432 | IMMUNOCCULT-LXI | Oct 31, 1988 | Substantially Equivalent | INTL. IMMUNOASSAY LABORATORIES, INC. |
| K882799 | HELENA COLOCARE | Sep 30, 1988 | Substantially Equivalent | HELENA LABORATORIES |
| K874180 | COLORECTAL CANCER RISK DETECTOR (TM) | Sep 30, 1988 | Substantially Equivalent | PEARCE CLINICAL LABORATORIES, INC. |
| K881907 | HEMAGEL(TM) TEST FOR FECAL OCCULT BLOOD | Jul 08, 1988 | Substantially Equivalent | ENZO BIOCHEM, INC. |
| K871143 | IMMUNOCCULT EIA TEST KIT | Jul 08, 1988 | Substantially Equivalent | INTL. IMMUNOASSAY LABORATORIES, INC. |
| K880499 | HEMOCCULT SENSITIVE TEST | May 23, 1988 | Substantially Equivalent | SMITH KLINE DIAGNOSTICS, INC. |
| K874482 | REVISED IMMUDIA HEM-SP | May 13, 1988 | Substantially Equivalent | SCHIFF & CO. |
| K873409 | WAKO(TM) PRETEST 6A | Feb 11, 1988 | Substantially Equivalent | WAKO CHEMICALS, USA, INC. |
| K862849 | HEMOCCULT WIPE TEST | Dec 09, 1986 | Substantially Equivalent | SMITH KLINE DIAGNOSTICS, INC. |
| K861731 | NATURAL DETECTOR SYSTEM | Nov 06, 1986 | Substantially Equivalent | U.S. HEALTH RESOURCES CORP. |
| K855237 | BIOTEL (TM)/ KIDNEY | May 06, 1986 | Substantially Equivalent | AMERICAN DIAGNOSTIC CORP. |
| K854358 | EZ DETECH-URINE BLOOD TEST STICKS | Apr 09, 1986 | Substantially Equivalent | SELF CARE SYSTEMS, INC. |
| K860028 | MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL | Apr 07, 1986 | Substantially Equivalent | SELF CARE SYSTEMS, INC. |
| K854619 | DETECTACULT | Mar 03, 1986 | Substantially Equivalent | IMMUNOSTICS CO., INC. |
| K853141 | ACCESS DIGIWIPE SYSTEM | Nov 18, 1985 | Substantially Equivalent | MED TECH PRODUCTS, INC. |
| K850431 | EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL | Jun 17, 1985 | Substantially Equivalent | NMS PHARMACEUTICALS, INC. |
| K843601 | ACCESS HEMAWIPE | Jan 04, 1985 | Substantially Equivalent | MED TECH PRODUCTS, INC. |
| K843532 | UROPAPER EIKEN 8 | Dec 12, 1984 | Substantially Equivalent | SYN-KIT, INC. |
| K843352 | COLOSCREEN SELF-TEST | Dec 05, 1984 | Substantially Equivalent | HELENA LABORATORIES |
| K842137 | OCCULT BLOOD TEST | Sep 05, 1984 | Substantially Equivalent | BREIT LABORATORIES, INC. |
| K840527 | COLOTRAK OCCULT BLOOD TEST | Sep 05, 1984 | Substantially Equivalent | BREIT LABORATORIES, INC. |
| K840904 | ACCU-CULT FECAL OCCULT BLOOD TEST | Aug 16, 1984 | Substantially Equivalent | APPLIED MEDICAL DEVICES, INC. |
| K840903 | HELENA COLOSCREEN SELF-TEST | Aug 10, 1984 | Substantially Equivalent | HELENA LABORATORIES |
| K833369 | EARLY DETECTOR | Aug 02, 1984 | Substantially Equivalent | WARNER-LAMBERT CO. |
| K832311 | HEMOCCULT-C | Feb 27, 1984 | Substantially Equivalent | MENLEY & JAMES LABORATORIES |
| K834297 | PROPPER SERACULT | Jan 27, 1984 | Substantially Equivalent | PROPPER MFG. CO., INC. |
| K834456 | HELENA BIO STRIP OB | Jan 13, 1984 | Substantially Equivalent | HELENA LABORATORIES |
| K832864 | COLOSCREEN V.P.I. | Nov 21, 1983 | Substantially Equivalent | HELENA LABORATORIES |
| K830919 | OCCULT-ALERT | Jul 07, 1983 | Substantially Equivalent | BETA MED PHARMACEUTICALS, INC. |
| K830223 | FECAL OCCULT SLIDE TEST KIT | Mar 07, 1983 | Substantially Equivalent | CAMBRIDGE CHEMICAL PRODUCTS, INC. |
| K822731 | HEMOTECT | Oct 18, 1982 | Substantially Equivalent | BIO-CHEM LABORATORIES |
| K821884 | GASTROCCULT TM | Oct 08, 1982 | Substantially Equivalent | SMITH KLINE DIAGNOSTICS, INC. |
| K812728 | FLEET DETECTATEST | Jul 02, 1982 | Substantially Equivalent | C.B. FLEET CO., INC. |
| K820072 | FE-CULT PLUS | Mar 04, 1982 | Substantially Equivalent | GAMMA BIOLOGICALS, INC. |
| K813204 | SERACULT OCCULT BLOOF TEST | Jan 28, 1982 | Substantially Equivalent | PROPPER MFG. CO., INC. |
| K811815 | UROPAPER EIKEG | Dec 10, 1981 | Substantially Equivalent | SYN-KIT, INC. |
| K811752 | FE-CULT PLUS | Nov 02, 1981 | Substantially Equivalent | GAMMA BIOLOGICALS, INC. |
| K812428 | HELENA COLOSCREEN METHOD | Oct 23, 1981 | Substantially Equivalent | HELENA LABORATORIES |
| K810488 | HOME HEALTH CHEKUP KIT | May 08, 1981 | Substantially Equivalent | HEALTHKIT |
| K800433 | HELENA COLOCHECK | May 02, 1980 | Substantially Equivalent | HELENA LABORATORIES |
| K792655 | HELENA COLOSCREEN | Jan 24, 1980 | Substantially Equivalent | HELENA LABORATORIES |
| K780564 | FECATEST | Jun 30, 1978 | Substantially Equivalent | OTTO C. WATZKA |
| K780214 | HEMO FEC | May 03, 1978 | Substantially Equivalent | BOEHRINGER MANNHEIM CORP. |
| K770153 | CAMCO R PAK-GUAIAC | Feb 08, 1977 | Substantially Equivalent | CAMBRIDGE CHEMICAL PRODUCTS, INC. |
| K761232 | QUICK CULT SLIDE TEST FECAL OCCULT BLOOD | Dec 21, 1976 | Substantially Equivalent | LABORATORY DIAGNOSTICS CO., INC. |
FEI Numbers
This FDA classification entry is associated with 64 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 64 registration numbers. Click on an entry to view related FDA registrations.