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

JGQ — Predicate Candidate Screening

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

50 daysmedian FDA review time

134 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K131051	HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBU	Hitachi Chemical Diagnostics, Inc.	2013-06-07	53
K072638	ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #1187780	Roche Diagnostics Corp.	2007-10-19	31
K071239	TOTAL PROTEIN URINE/CSF GEN.3	Roche Diagnostics	2007-09-14	134
K981295	UPRO	Abbott Laboratories	1998-10-01	175
K981682	UPRO	Abbott Laboratories	1998-09-21	131
K925794	TRACE MICROPROTEIN REAGENT	Trace America, Inc.	1993-03-29	133
K913615	URINARY/CSF PROTEIN	Boehringer Mannheim Corp.	1991-09-13	31
K903914	PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANK	Baxter Healthcare Corp	1990-10-03	40
K901083	EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95	Em Diagnostic Systems, Inc.	1990-04-16	40
K863478	CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95	Em Diagnostic Systems, Inc.	1986-10-29	50
K842134	SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY	Somas Medical Industries, Inc.	1984-07-06	37
K822231	ACA URINARY PROTEIN ANALYTICAL TEST PACK	E.I. Dupont DE Nemours & Co., Inc.	1982-09-30	65
K780110	CSF TOTAL PROTEIN TEST SET #0340	Stanbio Laboratory	1978-03-03	43

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