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

JIR · Predicate Candidate Screening

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

90 daysmedian FDA review time

401 days90th percentile

38clearances measured

K-number	Device	Applicant	Decided	Review days
K222921	Minuteful-kidney test	Healthy.Io, Ltd.	2023-09-08	347
K210069	Minuteful - kidney test	Healthy.Io, Ltd.	2022-07-06	541
K150330	Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)	ACON Laboratories, Inc.	2015-04-30	79
K061419	TECO MICROALBUMIN 2-1 COMBO STRIPS	Teco Diagnostics	2007-01-26	249
K022538	IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790	Diagnostic Chemicals, Ltd. (Usa)	2002-08-23	22
K001810	URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TES	Flexsite Diagnostics, Inc.	2000-08-14	60
K994035	IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15	Diagnostic Chemicals , Ltd.	2000-02-01	64
K992257	NEW MULTIPLES REAGENT STRIPS	Bayer Corp.	1999-11-24	141
K991315	MICROALBUSTIX REAGENT STRIPS (OTC)	Bayer Corp.	1999-11-12	207
K983774	UALB	Abbott Laboratories	1999-01-28	94
K972960	HEALTH CHECK URI-TEST PROTEIN IN URINE	Tcpi, Inc.	1998-10-07	422
K982219	MICROALBUSTIX REAGENT STRIPS	Bayer Corp.	1998-08-12	49
K972337	DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA	Diagnostic Chemicals , Ltd.	1997-08-08	46
K970932	ORGENTEC MICRO-ALBUMIN EIA ASSAY	American Laboratory Products Co., Ltd.	1997-04-08	47
K963142	DCA 2000 + MICROALBUMIN/CREATININE ASSAY	Bayer Corp.	1996-09-27	45
K951222	TOTAL PROTEIN (URINE)	Randox Laboratories, Ltd.	1996-04-24	401
K960274	ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY	Orgentec	1996-03-29	70
K955438	URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION)	Teco Diagnostics	1996-01-29	82
K954346	CHEMSTRIP MICRAL URINE TEST STRIPS	Boehringer Mannheim Corp.	1995-10-26	38
K932950	TINA-QUANT MICROALBUMIN	Boehringer Mannheim Corp.	1995-02-10	603
K934146	N-ASSAY TIA MICROALBUMIN	Crestat Diagnostics, Inc.	1994-01-11	140
K922032	ENZIP URINARY MICROALBUMIN TEST	Diagnostic Specialties	1992-07-30	90
K920216	SYN ELISA MICRO ALBUMIN	Elias U.S.A., Inc.	1992-03-11	55
K912543	MICRO ALBUMIN EIA TEST KIT	Immuno Diagnostic Center, Inc.	1991-07-19	39
K912246	TARGET MICROALBUMINURIA TEST	Texas Immunology, Inc.	1991-07-19	59
K904752	CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS	Boehringer Mannheim Corp.	1991-04-12	175
K902204	STANBIO CSF/URINE TOTAL PROTEIN TEST SET	Stanbio Laboratory	1990-08-22	98
K896440	KENLOR PYROGALLOL RED MICROPROTEIN ASSAY KIT	Kenlor Industries, Inc.	1990-02-16	99
K894169	BIOTEL MICROALBUMINURIA (TM)	American Diagnostic Corp.	1989-09-18	95
K891544	DIALBUMIN	Exocell, Inc.	1989-06-09	84
K890846	BIOTROL URINE PROTEINS REAGENT	Biotrol, USA, Inc.	1989-03-21	28
K882538	PROGENE MICROALBUMINURIA SCREEN	Progene Corp.	1989-03-13	265
K885053	BIOTROL URINE PROTEINS REAGENT	Biotrol, USA, Inc.	1989-01-30	54
K884146	ALBUWELL	Exocell, Inc.	1989-01-23	112
K874909	MICRO-BUMINTEST REAGENT TABLETS	Miles Laboratories, Inc.	1988-04-28	149
K851338	DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI	Diagnostic Products Corp.	1986-04-07	369
K830977	HELENA BIOSTRIP P	Helena Laboratories	1983-04-28	30
K811219	KOVA STRIP 6	Icl Scientific	1981-05-21	17

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