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

LGC — Predicate Candidate Screening

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

126 daysmedian FDA review time

306 days90th percentile

38clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K033059	HERPES GROUP IGG	Trinity Biotech, Inc.	2003-11-26	58	0
K010878	MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L	Diagnostic Products Corp.	2001-04-18	30	0
K002262	DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM	Diamedix Corp.	2000-11-28	126	1
K000238	HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G	Mrl Diagnostics	2000-04-14	78	1
K992166	THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA T	Zeus Scientific, Inc.	1999-09-03	70	0
K983886	POCKIT HSV 2 RAPID TEST	Diagnology , Ltd.	1999-08-19	290	3
K984346	PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST	Meridian Diagnostics, Inc.	1999-06-25	203	0
K983656	HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM	Zeus Scientific, Inc.	1999-03-18	150	0
K983541	HSV 1+2 IGG ELISA TEST	Gull Laboratories, Inc.	1999-02-26	140	0
K981306	DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM	Diamedix Corp.	1998-09-29	172	0
K963645	HERPES GROUP IGG ELISA TEST SYSTEM	Armkel, LLC	1997-02-04	145	0
K963282	SERAQUEST HSV IGG	Quest Intl., Inc.	1997-01-22	154	0
K950670	IMMULITE HERPES I AND II IGG	Diagnostic Products Corp.	1996-06-21	494	0
K953839	PREMIER HSV PLUS	Meridian Diagnostics, Inc.	1996-05-23	281	0
K925208	ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION	Ortho Diagnostic Systems, Inc.	1992-12-28	91	0
K922334	BARTELS HERPES SIMPLEX VIRUS 1 IGM EIA	Baxter Diagnostics, Inc.	1992-12-15	216	0
K922333	BARTELS HERPES SIMPLEX VIRUS 2 IGM EIA	Baxter Diagnostics, Inc.	1992-12-15	216	0
K922759	HSV-2 IGM ELISA TEST--MODIFICATION	Gull Laboratories, Inc.	1992-10-05	119	0
K922758	HSV-1 IGM ELISA TEST -- MODIFICATION	Gull Laboratories, Inc.	1992-10-05	119	0
K922583	BARTELS HERPES SIMPLEX VIRUS 2 IGG EIA	Baxter Diagnostics, Inc.	1992-09-28	124	0
K922584	BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA	Baxter Diagnostics, Inc.	1992-09-18	114	0
K915551	ORTHO HSV ANTIGEN ELISA TEST	Ortho Diagnostic Systems, Inc.	1992-04-22	133	0
K910954	HSV-1 IGG ELISA TEST	Gull Laboratories, Inc.	1991-05-28	83	0
K910952	HSV-2 IGG ELISA TEST	Gull Laboratories, Inc.	1991-05-28	82	0
K910953	HSV-2 IGM ELISA TEST	Gull Laboratories, Inc.	1991-05-28	82	0
K910955	HSV-1 IGM ELISA TEST	Gull Laboratories, Inc.	1991-05-28	83	0
K910499	IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS	Vitek Systems, Inc.	1991-05-01	85	0
K903926	KODAK SURECELL HERPES (HSV) CONTROL FLUID SET	Eastman Kodak Company	1990-09-17	27	0
K903070	SEROCARD HSV IGG ANTIBODY TEST KIT	Disease Detection International, Inc.	1990-08-09	28	0
K900713	HERPTRAN CONCENTRATE	E.I. Dupont DE Nemours & Co., Inc.	1990-05-11	86	0
K871877	IDEIA HERPES SIMPLEX VIRUS TEST	Boots-Celltech Diagnostics, Inc.	1989-11-17	918	0
K884246	MODIFIED DDI SEROCARD HERPES IGG TEST KIT	Disease Detection International, Inc.	1989-04-10	181	0
K884680	KODAK SURECELL HERPES (HSV) TEST KIT	Eastman Kodak Company	1989-02-16	99	0
K843077	ELISA FOR HERPES SIMPLEX VIRUS	Scientific Research	1985-06-21	319	0
K843622	ABBOTT HSV EIA	Abbott Laboratories	1985-05-20	248	0
K834449	HSV ANTIGEN ELISA KIT	Ortho Diagnostic Systems, Inc.	1984-05-02	135	0
K822883	HERPELISA KIT	M.A. Bioproducts	1983-07-26	306	0
K802526	TEST KIT FOR DETECTION OF HERPES SIMPLEX	Bartels & Stout, Inc.	1981-02-09	117	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