Table 1.
FDA 510(k) Document Number and Test System/Manufacturera for CLIA-Waived and Moderate Complexity FITs.b
| No. FITs | No. 510(k) numbers | 510(k) Document Number | Test System/Manufacturer | Effective Date (mm/dd/yy) |
|---|---|---|---|---|
| CLIA-waived FITs | ||||
| 1 | 1 | E990036 | Alfa Scientific Designs Instant-View Fecal Occult Blood Test (Cassette) | 07/23/1999 |
| 2 | 2 | K002457 | ENTERIX INSURE FECAL OCCULT BLOOD TEST | 01/31/2001 |
| 3 | K002457 | ENTERIX INSURE FECAL IMMUNOCHEMICAL TEST | 10/16/2003 | |
| 4 | 3 | K021423 | ALFA SCIENTIFIC DESIGNS - ISCREEN FECAL OCCULT BLOOD TEST | 02/25/2005 |
| 5 | K021423 | QuickVue iFOB Test (Immunochemical Fecal Occult Blood) (Cassette) | 11/9/2005 | |
| 6 | 4 | K041202 | Clarity Hemosure One-Step Immunological Fecal Occult Blood Test | 03/30/2005 |
| 7 | K041202 | HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST | 09/8/2004 | |
| 8 | 5 | K041297 | Clearview Ultra FOB Test | 08/18/2004 |
| 9 | K041297 | OC-Light iFOB Test | 03/24/2011 | |
| 10 | K041297 | POLYMEDCO POLY STAT OC-LIGHT FOB TEST | 08/18/2004 | |
| 11 | 6 | K051806 | Care Fecal Occult Blood Test | 10/7/2005 |
| 12 | 7 | K052598 | Care Diagnostic Clarity IFOB Test | 01/26/2010 |
| 13 | K052598 | immoCARE Fecal Occult Blood Test | 03/22/2006 | |
| 14 | 8 | K060463 | Consult Diagnostics Immunochemical Fecal Occult Blood Test (iFOBT) | 07/8/2010 |
| 15 | K060463 | Henry Schein OneStep+ iFOBT | 03/5/2009 | |
| 16 | K060463 | Immunostics Inc. hema-screen SPECIFIC Immunochemical Fecal Occult Blood Test | 06/15/2006 | |
| 17 | K060463 | Select Diagnostics Immunochemical Fecal Occult Blood Test | 02/8/2007 | |
| 18 | 9 | K060930 | ENTERIX INSURE II FECAL IMMUNOCHEMICAL TEST | 08/3/2006 |
| 19 | K060930 | InSure Quik Fecal Immunochemical Test (F.I.T.) | 01/26/2007 | |
| 20 | 10 | K060953 | OcculTech Fecal Occult Blood Rapid Test | 09/22/2006 |
| 21 | 11 | K061065 | CLIAwaived Inc. Rapid Fecal Occult Blood Test | 11/9/2009 |
| 22 | K061065 | Teco Rapid Fecal Occult Blood (FOB) Card Test | 08/9/2006 | |
| 23 | K061065 | BTNX Inc. Rapid Response Immunological Fecal Occult Blood Test (IFOBT) | 07/22/2008 | |
| 24 | 12 | K063673 | Innovacon FOB Flipcard Fecal Occult Blood Test | 03/7/2007 |
| 25 | 13 | K063693 | Centralcheck iFOBT Complete Fecal Occult Blood Test | 11/16/2010 |
| 26 | K063693 | Forsure One Step Fecal Occult Blood (FOB) Screen Card Test | 05/16/2007 | |
| 27 | K063693 | GERMAINE LABORATORIES AimStep Immunological Fecal Occult Blood Test (iFOBT) | 09/9/2009 | |
| 28 | K063693 | Germaine Laboratories Compliance Gold iFOB (immunological fecal occult blood)Test | 07/1/2008 | |
| 29 | K063693 | Healthcare Provider Direct OneStep Fecal Occult Blood (FOB) Screen Card Test | 07/22/2008 | |
| 30 | K063693 | Inverness Medical Clearview iFOBT Complete Fecal Occult Blood Test | 03/1/2010 | |
| 31 | K063693 | Jant Pharmacal Accutest Immunological Fecal Occult Blood Test (iFOBT) | 12/4/2008 | |
| 32 | 14 | K070660 | Alfa Scientific Designs Fecal Occult Blood (FOB) Self-Test | 06/28/2007 |
| 33 | K070660 | Alfa Scientific Designs Instant-View Fecal Occult Blood (FOB) Self-Test (Cassette) | 06/28/2007 | |
| 34 | K070660 | BTNX Inc. Clarity Fecal Occult Blood (FOB) Self Test | 10/5/2007 | |
| 35 | K070660 | BTNX Inc. Know Fecal Occult Blood (FOB) Self Test | 10/5/2007 | |
| 36 | K070660 | BTNX Inc. Rapid Response Fecal Occult Blood (FOB) Self Test | 10/5/2007 | |
| 37 | K070660 | Medline Fecal Occult Blood Test (Cassette) | 08/22/2013 | |
| 38 | 15 | K071242 | AmeriTek dBest One Step Occult Blood Test | 03/12/2008 |
| 39 | 16 | K073431 | Jant Pharmacal Accutest Dual Sample Immunological Fecal Occult Blood (iFOB) Test | 12/4/2008 |
| 40 | K073431 | Tianjin New Bay Bioresearch Co. Ltd. ForeSure IFOB Dual-Sample Fecal Occult Blood Screen Card Test | 02/22/2012 | |
| 41 | 17 | K080812 | BECKMAN COULTER HEMOCCULT ICT | 07/1/2008 |
| 45 | 18 | K901064 | CHEMICON MONOHAEM | 05/15/2003 |
| 42 | 19 | K961062 | SmithKline FlexSure OBT | 02/28/1997 |
| 43 | K961062 | BECKMAN COULTER HEMOCCULT ICT | 05/26/2004 | |
| 44 | K961062 | BECKMAN COULTER HEMOCCULT ICT | 06/28/2004 | |
| 46 | 20 | K100031 | American IVD Biotechnology Services Inc. FOB/CRC Advanced+ | 10/4/2010 |
| 47 | K100031 | BTNX Inc. Rapid Response Fecal Immunochemical Test (FIT) | 10/4/2010 | |
| 48 | K100031 | IND Diagnostic Inc. One Step Fecal Occult Blood Test | 07/28/2010 | |
| 49 | K100031 | Medline iFOB One-Step Immunological Fecal Occult Blood Test | 04/19/2012 | |
| 50 | 21 | K100817/CR140487c | Medline iFOB TEST | 06/26/2015 |
| 51 | K100817 | Princeton BioMeditech BioSign Immunochemical Fecal Occult Blood Test (iFOBT) | 07/8/2010 | |
| 52 | K100817 | Status iFOBT | 10/19/2011 | |
| 53 | K100817/CR150328 | Sekisui Diagnostics LLC OSOM iFOB Test | 07/28/2015 | |
| 54 | 22 | K102664/CR160124 | Germaine Laboratories Inc. Compliance Gold Fecal Occult Blood Test | 04/20/2016 |
| 55 | 23 | K110309 | Orient Gene Biotech - One Step Rapid FOB | 09/20/2011 |
| 56 | K110309 | Rapid Response(TM) FIT - Fecal Immunochemical Test | 04/22/2014 | |
| 57 | K110309/CR150438 | Tanner Scientific IFOB One Step Rapid Test | 09/14/2015 | |
| 58 | K110309/CR150489 | Clarity Diagnostics One-Step Fecal Occult Blood Test | 10/6/2015 | |
| 59 | 24 | K121397 | OSOM® iFOB Test OSOM® iFOBT Control Kit | 01/3/2013 |
| 60 | 25 | K143325/CR140487 | Eiken Chemical Co. LTD OC-Light S FIT | 08/24/2015 |
| Moderate Complexity FITs | ||||
| 61 | 1 | K132167 | Boditech Med Inc. i-CHROMA iFOB with i-CHROMA Reader | 05/6/2014 |
| 62 | 2 | K092330 | OC Auto Sensor DIANA iFOB | 12/5/2013 |
| 63 | K092330 | OC Auto Micro 80 iFOB | 12/5/2013 | |
| 64 | 3 | K041408 | Polymedco OC Auto Micro 80 analyzer | 05/23/2005 |
| 65 | K092330d | Polymedco OC-Sensor DIANA iFOB Test | 01/20/2010 | |
Abbreviations: FDA, Food and Drug Administration; CLIA, Clinical Laboratory Improvement Amendments; FIT, fecal immunochemical test.
a
Test System/Manufacturer listed as presented on FDA CLIA Database.
b
Shading indicates the same test marketed under different names.
c
On March 21, 2014, CLIA started filing using CR as a prefix, with the Parent Document number with a prefix of K.
d
The correct document number should be K041408 (Helen Landicho, Senior Vice President of Regulatory Affairs, Polymedco).