CGN · Acid, Folic, Radioimmunoassay
Clinical Chemistry · 21 CFR 862.1295 · Class 2
Overview
| Product Code | CGN |
|---|---|
| Device Name | Acid, Folic, Radioimmunoassay |
| Regulation | 21 CFR 862.1295 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.
Classification Rationale
Class II.
Cleared Devices (64)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233060 | Elecsys Folate III | Roche Diagnostics | Jun 17, 2024 | SESE |
| K223590 | Access Folate Assay | Beckman Coulter, Inc. | Aug 23, 2023 | SESE |
| K192586 | LIAISON® Folate | DiaSorin, Inc. | May 6, 2020 | SESE |
| K172201 | Atellica IM Folate Assay | Siemens Healthcare Diagnostics, Inc. | Apr 12, 2018 | SESE |
| K161646 | Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set | Diazyme Laboratories | Nov 4, 2016 | SESE |
| K141426 | ELECSYS FOLATE III | Roche Diagnostics | Oct 17, 2014 | SESE |
| K103716 | ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET | Roche Diagnostics | May 12, 2011 | SESE |
| K092740 | ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74 | Abbott Laboratories | Mar 5, 2010 | SESE |
| K091332 | AIA-PACK RBC FOLATE | Tosoh Bioscience, Inc. | Oct 2, 2009 | SESE |
| K082340 | ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS | Roche Diagnostics Corp. | Jun 19, 2009 | SESE |
| K060774 | FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 | Beckman Coulter, Inc. | Apr 21, 2006 | SESE |
| K051292 | ELECSYS RBC FOLATE HEMOLYZED REAGENT | Roche Diagnostics Corp. | Jun 17, 2005 | SESE |
| K043318 | MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY | Roche Diagnostics Corp. | Dec 23, 2004 | SESE |
| K031756 | ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY | Roche Diagnostics Corp. | Jun 25, 2003 | SESE |
| K023397 | ABBOTT ARCHITECT FOLATE | Abbott Laboratories | Dec 16, 2002 | SESE |
| K010050 | ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY | Bayer Diagnostics Corp. | Feb 5, 2001 | SESE |
| K001266 | VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA | Ortho-Clinical Diagnostics, Inc. | May 2, 2000 | SESE |
| K993254 | IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06 | Diagnostic Products Corp. | Nov 12, 1999 | SESE |
| K992365 | AIA-PACK FOLATE ASSAY | Tosoh Medics, Inc. | Aug 10, 1999 | SESE |
| K991582 | CHIRON DIAGNOSTICS ACS: 180 FOLATE | Chiron Diagnostics Corp. | Jun 30, 1999 | SESE |
| K984301 | ABBOTT ARCHITECT FOLATE | Abbott Laboratories | Feb 5, 1999 | SESE |
| K984166 | VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12/FOLATE REAGENT P3 | Ortho-Clinical Diagnostics, Inc. | Feb 5, 1999 | SESE |
| K981931 | CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY | Roche Diagnostics/Boehringer Mannheim GmbH | Aug 25, 1998 | SESE |
| K972232 | ABBOTT AXSYM FOLATE | Abbott Laboratories | Jun 24, 1997 | SESE |
| K964349 | AIA-PACK FOLATE ASSAY | Tosoh Medics, Inc. | Nov 27, 1996 | SESE |
| K960800 | CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK) | Boehringer Mannheim Corp. | Jul 26, 1996 | SESE |
| K955434 | ACCESS FOLATE ASSAY (MODIFICATION) | Beckman Coulter, Inc. | Jan 29, 1996 | SESE |
| K954332 | RBCFOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM | Bayer Corp. | Jan 24, 1996 | SESE |
| K951155 | CEDIA FOLATE (NO BOIL) ASSAY | Microgenics Corp. | Jun 29, 1995 | SESE |
| K950292 | FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEM | Miles, Inc. | May 2, 1995 | SESE |
| K943691 | IMX FOLATE | Abbott Mfg., Inc. | Mar 23, 1995 | SESE |
| K944212 | RADIAS RED CELL FOLATE IMMUNOASAY | Bio-Rad | Feb 3, 1995 | SESE |
| K946184 | CEDIA(R) FOLATE (NO BOIL) ASSAY | Microgenics Corp. | Jan 17, 1995 | SESE |
| K943297 | CIBA CORNING ACS FOLATE ASSAY | Ciba Corning Diagnostics Corp. | Dec 12, 1994 | SESE |
| K943705 | FOLIC ACID | Diagnostic Products Corp. | Oct 31, 1994 | SESE |
| K943149 | ACCESS RED BLOOD CELL FOLATE ASSAY | Beckman Coulter, Inc. | Aug 26, 1994 | SESE |
| K935286 | QUANTAPHASE II B12/FOLATE | Bio-Rad | Feb 18, 1994 | SESE |
| K934121 | VISTA FOLATE ASSAY | Syva Co. | Oct 22, 1993 | SESE |
| K932887 | ACCESS FOLATE ASSAY | Beckman Coulter, Inc. | Oct 12, 1993 | SESE |
| K933571 | RADIAS FOLATE ENZYME IMMUNOASSAY | Bio-Rad | Oct 1, 1993 | SESE |
| K923286 | STRATUS FOLATE FLUOROMETRIC ENZYME-LINKED ASSAY | Baxter Diagnostics, Inc. | Sep 17, 1992 | SESE |
| K922823 | ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS | Bio-Rad Laboratories, Inc. | Aug 5, 1992 | SESE |
| K921614 | MILENIA FOLIC ACID | Diagnostic Products Corp. | Jun 25, 1992 | SESE |
| K921689 | CEDIA RED BLOOD CELL FOLATE REAGENT PACK | Microgenics Corp. | Jun 16, 1992 | SESE |
| K893684 | CIBA CORNING MAGIC LITE FOLATE IMMUNOASSAY | Ciba Corning Diagnostics Corp. | Jul 27, 1989 | SESE |
| K841302 | DIAGNON FOLATE 125I RIA KIT | Diagnon Corp. | Jun 22, 1984 | SESE |
| K832712 | FOLATE RADIOASSAY KIT CA-1562-125 | Clinical Assays, Inc. | Oct 4, 1983 | SESE |
| K822728 | SOLID PHASE SIMUL TRAC VITAMIN B12 | Bd Becton Dickinson Vacutainer Systems Preanalytic | Nov 5, 1982 | SESE |
| K812979 | VITAMIN B12/FOLATE DUAL RADIOASSAY KITS | Amersham Corp. | Nov 24, 1981 | SESE |
| K811177 | QUANTA PHASE VITAMIN B-12/FOLATE RAD | Bio-Rad | May 15, 1981 | SESE |
| K810186 | MICROMEDIC SYSTEMS' AUTOPAK | Micromedic Systems | Feb 4, 1981 | SESE |
| K810001 | 'NO-BOIL' DUALCOUNT KIT | Diagnostic Products Corp. | Jan 16, 1981 | SESE |
| K803060 | FOLATE 125I RADIOIMMUNOASSAY | Corning Medical & Scientific | Dec 22, 1980 | SESE |
| K801198 | FOLATE RADIOASSAY KIT | Calbiochem-Behring Corp. | Jul 21, 1980 | SESE |
| K800914 | NO-BOIL FOLATE KIT #RP-500 | Ria Products, Inc. | May 8, 1980 | SESE |
| K792167 | 125 I FOLATE SOLID PHASE RADIOASSAY | Abbott Laboratories | Nov 13, 1979 | SESE |
| K791079 | GAMMADAB (125 1) FOLATE RADIOASSAY KIT | Clinical Assays, Inc. | Jul 17, 1979 | SESE |
| K780557 | FOLATE REAGENT KIT, ARIA-II SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | May 18, 1978 | SESE |
| K780508 | QUANTITOPE 125I-FOLATE RADIOASSAY KIT | Kallestad Laboratories, Inc. | May 3, 1978 | SESE |
| K780148 | RIA FOR FOLATES & VIT. B12, COMBO KIT | Ria Products, Inc. | Mar 3, 1978 | SESE |
| K771597 | IN VITRO FOLATE RADIOASSAY KIT | Clinical Assays, Inc. | Sep 13, 1977 | SESE |
| K760262 | RADIOASSY KIT, 3H-FOLATE | Diamond Shamrock Corp. | Aug 3, 1976 | SESE |
| K760207 | KIT, FOLATE RADIOASSAY SC.7 | Amersham Corp. | Jul 26, 1976 | SESE |
| K760133 | PROCEDURE, RED CELL FOLATE ASSAY | Bio-Rad | Jul 20, 1976 | SESE |
Top Applicants
- Bio-Rad — 5 clearances
- Beckman Coulter, Inc. — 5 clearances
- Abbott Laboratories — 5 clearances
- Roche Diagnostics Corp. — 4 clearances
- Diagnostic Products Corp. — 4 clearances
