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

Quantimetrix Corp. — Predicate Candidate Screening

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

67 daysmedian FDA review time

191 days90th percentile

38clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K142262	AUTION CHECK PLUS	Quantimetrix Corp.	2015-04-10	239	0
K113177	COMPLETE D 25-OH VITAMIN D CONTROL	Quantimetrix Corp.	2012-05-10	195	0
K103744	DROPPER A1C DIABETES CONTROL	Quantimetrix Corp.	2011-05-12	140	0
K062942	QUANTIMETRIX NICOSURE COTININE URINE CONTROL	Quantimetrix Corp.	2006-10-30	32	0
K062751	MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER	Quantimetrix Corp.	2006-10-03	19	0
K060417	MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL	Quantimetrix Corp.	2006-03-21	32	0
K032791	GLYCOHEMOSURE HBA1C CONTROL	Quantimetrix Corp.	2003-10-30	52	0
K030826	PRECISET DAT AMPHETAMINE	Quantimetrix Corp.	2003-04-03	20	0
K021393	PRECISET DAT PLUS	Quantimetrix Corp.	2002-06-13	42	0
K013662	MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS	Quantimetrix Corp.	2002-03-08	122	0
K010337	LIPOPRINT SYSTEM, LDL SUBFRACTIONS	Quantimetrix Corp.	2001-07-25	170	0
K010598	SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL	Quantimetrix Corp.	2001-03-23	23	1
K993723	CARDIASURE CARDIAC MARKERS CONTROL	Quantimetrix Corp.	1999-11-23	20	0
K973894	IMMUSURE	Quantimetrix Corp.	1997-10-29	15	0
K970862	SPINALSCOPICS	Quantimetrix Corp.	1997-04-08	32	1
K943394	PROSTAT CONTROL	Quantimetrix Corp.	1995-05-23	313	0
K943925	SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING	Quantimetrix Corp.	1994-10-04	53	0
K941130	ASSURE URINE HCG CONTROL	Quantimetrix Corp.	1994-06-03	86	0
K932623	QUANTIMETRIX BLOOD GLUCOSE CONTROLS	Quantimetrix Corp.	1993-12-09	191	0
K931523	QUANTIMETRIX C-CLEAR(TM)	Quantimetrix Corp.	1993-06-25	91	0
K925256	QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROL	Quantimetrix Corp.	1993-03-01	133	1
K913346	QUANTIMETRIX AMMONIA CONTROLS	Quantimetrix Corp.	1991-09-25	61	0
K880701	QUANTIMETRIX SERUM ENZYME CONTROL	Quantimetrix Corp.	1988-03-24	31	0
K863388	QUANTIMETRIX DRUG FREE SERUM CONTROL	Quantimetrix Corp.	1986-09-29	26	0
K861420	QUANTIMETRIX DRUG FREE HUMAN URINE CONTROL	Quantimetrix Corp.	1986-09-16	154	0
K860942	QUANTIMETRIX HUMAN BILIRUBIN CONTROL I & II LIQUID	Quantimetrix Corp.	1986-05-23	72	0
K853932	QUANTTEST TOTAL PROTEIN ASSAY	Quantimetrix Corp.	1985-12-19	86	0
K853930	QUANTIMETRIX BIURET SERUM TOTAL PROTEIN ASSAY KIT	Quantimetrix Corp.	1985-12-10	77	0
K853933	QUANTIMETRIX HUMAN SERUM THERAPEUTIC DRUG CONTROL	Quantimetrix Corp.	1985-10-04	10	0
K853931	QUANTIMETRIX HUMAN SERUM CHEMISTRY CONTROL	Quantimetrix Corp.	1985-10-04	10	0
K843818	HUMAN SERUM ANTICONVULSANT DRUG CONTROL	Quantimetrix Corp.	1984-10-30	32	0
K843679	HUMAN SERUM CARDIOACTIVE DRUG CONTROL	Quantimetrix Corp.	1984-10-05	17	0
K834505	HUMAN SERUM ELECTROLYTE CONTROL-LIQUID	Quantimetrix Corp.	1984-04-13	114	0
K832045	ACETAMINOPHER ASSAY KIT	Quantimetrix Corp.	1983-10-04	102	0
K831526	URINE TOTAL PROTEIN CONTROL	Quantimetrix Corp.	1983-08-12	92	0
K831527	SPINAL FLUID TOTAL PROTEIN CONTROL	Quantimetrix Corp.	1983-07-18	67	0
K831336	SALICYLATE ASSAY KIT	Quantimetrix Corp.	1983-07-07	73	0
K830934	QUANTIMETRIX BROMERESOL PURPLE ALBUMIN	Quantimetrix Corp.	1983-04-18	26	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