Product Code: CDD FDA class 2 21 CFR 862.1810

Radioassay, Vitamin B12

Clinical Chemistry

The Vitamin B12 Radioassay is a clinical chemistry device that uses radioisotope-based competitive binding or immunoassay techniques to measure the concentration of vitamin B12 (cobalamin) in blood or serum, used in the diagnosis of nutritional deficiencies, pernicious anemia, and related conditions. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CDD, regulated under 21 CFR 862.1810, within the Clinical Chemistry medical specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

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Unique Applicants

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Basic Information

Product Code: CDD
Device Class: FDA class 2
Regulation Number: 862.1810
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 78 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K233541	ARCHITECT Active-B12 (Holotranscobalamin)	Jul 31, 2024	Substantially Equivalent	Axis-Shield Diagnostics, Ltd.
K223289	Access Vitamin B12	Dec 23, 2022	Substantially Equivalent	Beckman Coulter, Inc.
K190298	DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12	Oct 04, 2019	Substantially Equivalent	Beckman Coulter Biomedical GmbH
K192064	LIAISON Vitamin B12	Oct 02, 2019	Substantially Equivalent	DiaSorin, Inc.
K172133	ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay	Oct 27, 2017	Substantially Equivalent	Axis-Shield Diagnostics, Ltd.
K161721	Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set	Sep 20, 2016	Substantially Equivalent	Diazyme Laboratories
K160757	ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)	Jul 26, 2016	Substantially Equivalent	Axis-Shield Diagnostics Limited
K151786	Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet	Sep 24, 2015	Substantially Equivalent	Roche Diagnostics
K140496	Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents	Sep 16, 2014	Substantially Equivalent	Beckman Coulter, Inc.
K133512	LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)	Jan 02, 2014	Substantially Equivalent	Siemens Healthcare Diagnostics
K121946	AXIS-SHIELD ACVTIVE-B12	Mar 22, 2013	Substantially Equivalent	Axis-Shield Diagnostics, Ltd.
K121994	DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR	Nov 30, 2012	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K111260	A/C ENZYMATIC VITAMIN B6 ASSAY	Jul 26, 2012	Substantially Equivalent	Anticancer, Inc.
K121314	ARCHITECT B12	May 17, 2012	Substantially Equivalent	Abbott Laboratories
K112443	ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)	Dec 19, 2011	Substantially Equivalent	Axis-Shield Diagnostics, Ltd.
K110579	ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS	Oct 06, 2011	Substantially Equivalent	Abbott Laboratories
K110413	POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS	May 11, 2011	Substantially Equivalent	Beckman Coulter, Inc.
K093631	B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644	Feb 12, 2010	Substantially Equivalent	Siemens Healthcare Diagnostics
K090588	POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210	May 27, 2009	Substantially Equivalent	Beckman Coulter, Inc.
K071224	DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR	Nov 13, 2007	Substantially Equivalent	Dade Behring, Inc.
K062467	AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10	Nov 22, 2006	Substantially Equivalent	Axis-Shield Diagnostics, Ltd.
K060929	IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6	Apr 28, 2006	Substantially Equivalent	Diagnostic Products Corporation
K060755	ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK	Apr 10, 2006	Substantially Equivalent	Roche Diagnostics Corp.
K051327	ABBOTT AXSYM B12	Aug 03, 2005	Substantially Equivalent	Abbott Laboratories
K041133	MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER	Jul 02, 2004	Substantially Equivalent	Bayer Healthcare, LLC
K030655	HOLOTC RIA	Jan 29, 2004	Substantially Equivalent	Axis-Shield Biochemicals, Asa
K013899	VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS	Jan 24, 2002	Substantially Equivalent	Ortho-Clinical Diagnostics
K993571	BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12	Dec 16, 1999	Substantially Equivalent	Bayer Corp.
K984321	VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS	Jan 22, 1999	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K973702	ELECSYS VITAMIN B12 ASSAY	Nov 13, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K973674	ELECSYS FOLATE	Nov 12, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K971177	IMMULITE VITAMIN B12 (LKVB1,LKVB5)	May 16, 1997	Substantially Equivalent	Diagnostic Products Corp.
K965186	AXSYM B12	Mar 24, 1997	Substantially Equivalent	Abbott Laboratories
K964348	AIA-PACK B12 ASSAY	Jan 13, 1997	Substantially Equivalent	Tosoh Medics, Inc.
K955561	BUHLMANN VITAMIN B6 REA	May 23, 1996	Substantially Equivalent	American Laboratory Products Co., Ltd.
K955436	ACCESS VITAMIN B12 ASSAY (MODIFICATION)	Jan 24, 1996	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K953455	OPUS B12	Aug 23, 1995	Substantially Equivalent	Behring Diagnostics, Inc.
K951134	CEDIA VITAMIN B12 (NO BOIL) ASSAY	Jul 11, 1995	Substantially Equivalent	Microgenics Corp.
K941235	VISTA B12 ASSAY	Aug 15, 1994	Substantially Equivalent	Syva Co.
K933142	ACCESS VITAMIN B12 ASSAY	Nov 05, 1993	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K933315	RADIAS B12 ENZYME IMMUNOASSAY	Aug 25, 1993	Substantially Equivalent	Bio-Rad
K924074	STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED	Oct 26, 1992	Substantially Equivalent	Baxter Diagnostics, Inc.
K920078	AFFINITY B12	Feb 14, 1992	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K913646	CIBA CORNING ACS T3 IMMUNOASSAY	Oct 25, 1991	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K910343	CIBA CORNING ACS VITAMIN B12 IMMUNOASSAY	Mar 06, 1991	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K904776	CEDIA (R) VITAMIN B12/FOLATE ASSAY	Nov 20, 1990	Substantially Equivalent	Microgenics Corp.
K883722	CIBA CORNING MAGIC LITE VITAMIN B12 IMMUNOASSAY	Nov 04, 1988	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K860815	SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB)	Jul 11, 1986	Substantially Equivalent	Diagnostic Products Corp.
K854945	MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY	Feb 11, 1986	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K853224	PHASE II B-12/FOLATE KIT	Oct 03, 1985	Substantially Equivalent	Medical & Scientific Designs, Inc.
K853127	MICROMEDIC COMBOSTAT B B12/FOLATE(BOIL)	Sep 16, 1985	Substantially Equivalent	Micromedic Systems
K851377	DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA	Aug 21, 1985	Substantially Equivalent	Diagnon Corp.
K840462	VITAMIN B12 57CO/FOLATE 125I -	Jun 25, 1984	Substantially Equivalent	Corning Medical & Scientific
K833142	ANTIBODY TO INTRINSIC FACTOR RADIOASSAY	Jan 30, 1984	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K832717	DIAGNON B12 57CO RIA KIT	Dec 08, 1983	Substantially Equivalent	Diagnon Corp.
K833247	QUANTAPHASE B-12-COBALMIN-FOLATE-	Oct 19, 1983	Substantially Equivalent	Bio-Rad
K832711	VITAMIN B12 FOLATE CA-1515-125	Oct 04, 1983	Substantially Equivalent	Clinical Assays, Inc.
K832710	VITAMIN B12 RADIOASSAY KIT CA-1534	Oct 04, 1983	Substantially Equivalent	Clinical Assays, Inc.
K832726	INTRINSIC FACTOR BLOCKING ANTIBODY KIT	Sep 29, 1983	Substantially Equivalent	Diagnostic Products Corp.
K822721	NO-BOIL SOLID PHASE SIMUL TRAC B12	Mar 10, 1983	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K830195	NO BOIL DUAL COUNT VIT-B12 & FOLIC ACID	Feb 18, 1983	Substantially Equivalent	Diagnostic Products Corp.
K813183	NO-BOIL VITABIN B12 5760 FOLATE 125I	Mar 05, 1982	Substantially Equivalent	Corning Medical & Scientific
K813310	NO-HOIL COMBOSTAT II KIT	Dec 17, 1981	Substantially Equivalent	Ria Products, Inc.
K810002	'NO-BOIL' VITAMIN B12 KIT	Jan 16, 1981	Substantially Equivalent	Diagnostic Products Corp.
K802220	VITAMIN B12 (57CO) RADIOIMMUNOASSAY	Jan 09, 1981	Substantially Equivalent	Corning Medical & Scientific
K801579	VITAMIN B12 - NO-BOIL KIT	Oct 23, 1980	Substantially Equivalent	Ria Products, Inc.
K801578	COMBOSTAT - NO-BOIL KIT	Oct 23, 1980	Substantially Equivalent	Ria Products, Inc.
K792460	CALBIOCHEM-BEHRING RIA-COUNT	Feb 13, 1980	Substantially Equivalent	Calbiochem-Behring Corp.
K792175	RIANEN, VITAMIN B12 ASSAY SYSTEM	Nov 13, 1979	Substantially Equivalent	New England Nuclear
K791216	CENTRIA VITAMIN B12 FOLATE RADIO SET	Nov 13, 1979	Substantially Equivalent	Ventrex Laboratories, Inc.
K790347	AUTO PAK VITAMIN B-12	Sep 27, 1979	Substantially Equivalent	Micromedic Systems
K782024	RIA KIT, VITAMIN B12	Feb 28, 1979	Substantially Equivalent	Technia Diagnostics , Ltd.
K781410	RIALYZE VITAMIN B-12 TEST	Sep 27, 1978	Substantially Equivalent	Ames Div., Miles Laboratories, Inc.
K780799	VITAMIN B12 RADIOASSAY	Jun 13, 1978	Substantially Equivalent	Amersham Corp.
K771047	QUANTA-MATE VITAMIN B-12/FOLATE RA	Jun 27, 1977	Substantially Equivalent	Bio-Rad
K761321	VITAMIN B12 RADIOASSAY	Mar 21, 1977	Substantially Equivalent	Kallestad Laboratories, Inc.
K760946	B12/FOLATE SING. TUBE DUAL RADIOASSAY KT	Dec 21, 1976	Substantially Equivalent	Schwarz Mann
K760619	RADIO IMMUNO ASSAY KIT/	Dec 06, 1976	Substantially Equivalent	New England Nuclear