Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

DCF — Predicate Candidate Screening

37 FDA 510(k) clearances under this product code; the 50 most recent screened below.

66 daysmedian FDA review time

255 days90th percentile

37clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K153560	Optilite Low Level Albumin Kit	The Binding Site Group , Ltd.	2016-08-25	255	0
K143118	Human Microalbumin kit for use on SPAPLUS	The Binding Site Group , Ltd.	2015-05-26	208	0
K142346	Urine/CSF Albumin, Urine/CSF Albumin Calibrator	Beckman Coulter Ireland, Inc.	2014-10-15	54	0
K121045	HUMAN ALBUMIN CSF KIT	The Binding Site Group , Ltd.	2013-06-19	439	0
K113072	TINA-QUANT ALBUMIN GEN.2	Roche Diagnostics Operations	2012-05-14	210	0
K101089	EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR	Medica Corp.	2011-07-13	450	0
K101203	TINA-QUANT ALBUMIN GEN 2	Roche Diagnostics	2010-09-10	134	0
K100853	COBAS 8000 MODULAR SERIES ANALYZER	Roche Diagnostics Corp.	2010-09-09	167	3
K091486	K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR	Kamiya Biomedical Co.	2010-04-29	345	0
K082251	SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100	Beckman Coulter, Inc.	2009-04-08	243	0
K061990	DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN	Dade Behring, Inc.	2006-09-19	68	0
K053553	NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL	Polymedco, Inc.	2006-03-09	79	0
K051191	DCL MICROALBUMIN ASSAY, MODEL 252-20	Diagnostic Chemicals , Ltd.	2005-07-05	56	0
K042643	VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MA	Ortho-Clinical Diagnostics, Inc.	2004-11-18	52	1
K033525	DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD,	Dade Behring, Inc.	2004-01-12	66	0
K972929	N ANTISERUM TO HUMAN ALBUMIN	Behring Diagnostics, Inc.	1997-10-20	73	0
K964695	IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT	Beckman Instruments, Inc.	1997-04-29	158	0
K961824	COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOX	Roche Diagnostic Systems, Inc.	1996-07-23	74	0
K953927	LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECK	International Enzymes, Inc.	1995-09-15	31	0
K914391	ALBUMIN TEST RID KIT	The Binding Site, Ltd.	1991-12-10	70	0
K900167	TURBIQUANT IMMUNOGLOBULIN & ALBUMIN KIT	Behring Diagnostics, Inc.	1990-01-22	10	0
K896059	MODIFIED QM300 ALBUMIN ANTIBODY PACK	Kallestad Diag, A Div. of Erbamont, Inc.	1989-11-06	19	0
K895808	TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN	Technicon Instruments Corp.	1989-10-17	15	0
K882153	TECHNICON DPA-1(TM) SYSTEM	Technicon Instruments Corp.	1988-08-04	73	0
K882082	QM300 ALBUMIN ANTIBODY PACK	Kallestad Diag, A Div. of Erbamont, Inc.	1988-07-08	51	0
K881127	QM300 CALIBRATOR D PACK	Kallestad Diag, A Div. of Erbamont, Inc.	1988-04-21	36	0
K881126	QM300 ALBUMIN ANTIBODY PACK	Kallestad Diag, A Div. of Erbamont, Inc.	1988-04-06	21	0
K875161	MAT (TM) MICROALBUMIN TEST	Wampole Laboratories	1988-02-17	64	0
K873862	ALBUMIN IN SERUM	Unipath , Ltd.	1987-10-20	57	0
K873861	ALBUMIN IN URINE	Unipath , Ltd.	1987-10-13	50	0
K862671	MICROALBUMINURIA ASSAY	Orion Corp.	1986-09-18	66	0
K851285	RADIAL IMMUNODIFFUSION PLATES CSF IGG & CSF ALBUMI	Cooper Biomedical, Inc.	1985-06-17	77	0
K812496	IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALBUM	Dako Corp.	1981-09-23	23	0
K802404	ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE	Ortho Diagnostics, Inc.	1980-10-23	17	0
K780913	ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM	Beckman Instruments, Inc.	1978-06-22	17	0
K771771	QUAN. COLOR. DETER. OF SERUM ALBUMIN	Stanbio Laboratory	1977-10-07	18	0
K761225	LOW LEVEL HUMAN ALBUMIN TEST KITS	Intl. Diagnostic Technology	1977-04-07	120	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda