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

LCO · Predicate Candidate Screening

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

92 daysmedian FDA review time

170 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K243374	HemosIL CL HIT-IgG(PF4-H)	Instrumentation Laboratory (IL) Co.	2025-01-28	90	0
K201570	PF4 Enhanced assay	Immucor Gti Diagnostics, Inc.	2020-09-11	92	0
K201311	PF4 IgG assay	Immucor Gti Diagnostics, Inc.	2020-06-18	31	0
K170854	HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls	Instrumentation Laboratory CO	2017-09-08	170	0
K153137	HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls	Instrumentation Laboratory CO	2016-07-08	252	0
K071781	PF4 IGG	Genetic Testing Institute	2007-12-19	170	0
K071255	ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A	Hyphen Biomed	2007-09-07	126	3
K053559	PF4 ENHANCED SOLID PHASE ELISA	Genetic Testing Institute	2006-01-20	30	2
K040293	HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY	Akers Laboratories, Inc.	2004-05-28	112	0
K003767	ASSERACHROM HPIA TEST KIT	Diagnostica Stago, Inc.	2001-02-12	68	1
K983379	GTI-PF4 ELISA	Genetic Testing Institute	1999-03-09	165	0
K890633	ENZYGNOST PLATELET FACTOR 4 (PF4) KIT	Behring Diagnostics, Inc.	1989-04-21	72	0
K862774	ASSERACHROM PF4 KIT	American Bioproducts Co.	1986-09-04	44	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