Product Code: DCF FDA class 2 21 CFR 866.5040

Albumin, Antigen, Antiserum, Control

Immunology

This is an immunological reagent kit for detecting and quantifying albumin, the most abundant plasma protein responsible for maintaining oncotic pressure and transporting various molecules in the bloodstream, including antigen, antiserum, and control components for use in clinical immunology laboratories. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is DCF, regulated under 21 CFR 866.5040, within the Immunology specialty.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: DCF
Device Class: FDA class 2
Regulation Number: 866.5040
Medical Specialty: Immunology
Review Panel: IM
Submission Type: 4

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 37 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K153560	Optilite Low Level Albumin Kit	Aug 25, 2016	Substantially Equivalent	The Binding Site Group , Ltd.
K143118	Human Microalbumin kit for use on SPAPLUS	May 26, 2015	Substantially Equivalent	The Binding Site Group , Ltd.
K142346	Urine/CSF Albumin, Urine/CSF Albumin Calibrator	Oct 15, 2014	Substantially Equivalent	Beckman Coulter Ireland, Inc.
K121045	HUMAN ALBUMIN CSF KIT	Jun 19, 2013	Substantially Equivalent	The Binding Site Group , Ltd.
K113072	TINA-QUANT ALBUMIN GEN.2	May 14, 2012	Substantially Equivalent	Roche Diagnostics Operations
K101089	EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR	Jul 13, 2011	Substantially Equivalent	Medica Corp.
K101203	TINA-QUANT ALBUMIN GEN 2	Sep 10, 2010	Substantially Equivalent	Roche Diagnostics
K100853	COBAS 8000 MODULAR SERIES ANALYZER	Sep 09, 2010	Substantially Equivalent	Roche Diagnostics Corp.
K091486	K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR	Apr 29, 2010	Substantially Equivalent	Kamiya Biomedical Co.
K082251	SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100	Apr 08, 2009	Substantially Equivalent	Beckman Coulter, Inc.
K061990	DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL	Sep 19, 2006	Substantially Equivalent	Dade Behring, Inc.
K053553	NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL	Mar 09, 2006	Substantially Equivalent	Polymedco, Inc.
K051191	DCL MICROALBUMIN ASSAY, MODEL 252-20	Jul 05, 2005	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K042643	VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II	Nov 18, 2004	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K033525	DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114	Jan 12, 2004	Substantially Equivalent	Dade Behring, Inc.
K972929	N ANTISERUM TO HUMAN ALBUMIN	Oct 20, 1997	Substantially Equivalent	Behring Diagnostics, Inc.
K964695	IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT	Apr 29, 1997	Substantially Equivalent	Beckman Instruments, Inc.
K961824	COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN	Jul 23, 1996	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K953927	LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM	Sep 15, 1995	Substantially Equivalent	International Enzymes, Inc.
K914391	ALBUMIN TEST RID KIT	Dec 10, 1991	Substantially Equivalent	The Binding Site, Ltd.
K900167	TURBIQUANT IMMUNOGLOBULIN & ALBUMIN KIT	Jan 22, 1990	Substantially Equivalent	Behring Diagnostics, Inc.
K896059	MODIFIED QM300 ALBUMIN ANTIBODY PACK	Nov 06, 1989	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K895808	TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN	Oct 17, 1989	Substantially Equivalent	Technicon Instruments Corp.
K882153	TECHNICON DPA-1(TM) SYSTEM	Aug 04, 1988	Substantially Equivalent	Technicon Instruments Corp.
K882082	QM300 ALBUMIN ANTIBODY PACK	Jul 08, 1988	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K881127	QM300 CALIBRATOR D PACK	Apr 21, 1988	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K881126	QM300 ALBUMIN ANTIBODY PACK	Apr 06, 1988	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K875161	MAT (TM) MICROALBUMIN TEST	Feb 17, 1988	Substantially Equivalent	Wampole Laboratories
K873862	ALBUMIN IN SERUM	Oct 20, 1987	Substantially Equivalent	Unipath , Ltd.
K873861	ALBUMIN IN URINE	Oct 13, 1987	Substantially Equivalent	Unipath , Ltd.
K862671	MICROALBUMINURIA ASSAY	Sep 18, 1986	Substantially Equivalent	Orion Corp.
K851285	RADIAL IMMUNODIFFUSION PLATES CSF IGG & CSF ALBUMI	Jun 17, 1985	Substantially Equivalent	Cooper Biomedical, Inc.
K812496	IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALBUM	Sep 23, 1981	Substantially Equivalent	Dako Corp.
K802404	ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE	Oct 23, 1980	Substantially Equivalent	Ortho Diagnostics, Inc.
K780913	ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM	Jun 22, 1978	Substantially Equivalent	Beckman Instruments, Inc.
K771771	QUAN. COLOR. DETER. OF SERUM ALBUMIN	Oct 07, 1977	Substantially Equivalent	Stanbio Laboratory
K761225	LOW LEVEL HUMAN ALBUMIN TEST KITS	Apr 07, 1977	Substantially Equivalent	Intl. Diagnostic Technology