Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

JIQ — Predicate Candidate Screening

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

131 daysmedian FDA review time

258 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K141925	TOTAL PROTEIN URINE/CSF GEN.3	Roche Diagnostics Operations (Rdo)	2014-12-09	146
K013643	AUSAM TOTAL ALBUMIN ASSAY	Ausam Biotecthnologies, Inc.	2003-08-14	647
K991800	HEMOCHEK URINE COLLECTION KIT	Osborn Group, Inc.	1999-09-24	121
K971458	ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT	Diagnostic Specialties	1997-09-02	133
K965035	IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT	Beckman Instruments, Inc.	1997-04-17	121
K944664	WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR	Wako Chemicals USA, Inc.	1995-02-07	138
K936202	URINARY ALBUMIN TEST PACK	Dupont Medical Products	1994-05-09	131
K935662	SYNERMED IR 500 CHEMISTRY ANALYZER	Synermed, Inc.	1994-04-26	151
K903123	RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT	Reagents Applications, Inc.	1990-09-14	60
K902216	WAKO(TM) MICRO-ALBUMIN	Wako Chemicals USA, Inc.	1990-06-18	33
K895883	BECKMAN MA MICROALBUMIN REAGENT KIT	Beckman Instruments, Inc.	1989-12-27	83
K870516	ALBUMIN SCREEN TEST	Sclavo, Inc.	1987-10-20	258
K842915	SULFOSALICYLIC ACID, 3% W/V	E K Ind., Inc.	1984-08-10	16

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