Product Code: LGC FDA class 2 21 CFR 866.3305

Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific

Microbiology

An enzyme-linked immunosorbent assay (ELISA) for herpes simplex virus (HSV) in a non-type-specific format is a laboratory test that detects antibodies to herpes simplex virus without distinguishing between HSV-1 and HSV-2, used for serological screening and diagnosis of herpes infection. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It bears product code LGC and is regulated under 21 CFR 866.3305 within the Microbiology specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

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Basic Information

Product Code: LGC
Device Class: FDA class 2
Regulation Number: 866.3305
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 38 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K033059	HERPES GROUP IGG	Nov 26, 2003	Substantially Equivalent	Trinity Biotech, Inc.
K010878	MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6	Apr 18, 2001	Substantially Equivalent	Diagnostic Products Corp.
K002262	DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM	Nov 28, 2000	Substantially Equivalent	Diamedix Corp.
K000238	HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G	Apr 14, 2000	Substantially Equivalent	Mrl Diagnostics
K992166	THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR	Sep 03, 1999	Substantially Equivalent	Zeus Scientific, Inc.
K983886	POCKIT HSV 2 RAPID TEST	Aug 19, 1999	Substantially Equivalent	Diagnology , Ltd.
K984346	PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST	Jun 25, 1999	Substantially Equivalent	Meridian Diagnostics, Inc.
K983656	HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM	Mar 18, 1999	Substantially Equivalent	Zeus Scientific, Inc.
K983541	HSV 1+2 IGG ELISA TEST	Feb 26, 1999	Substantially Equivalent	Gull Laboratories, Inc.
K981306	DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM	Sep 29, 1998	Substantially Equivalent	Diamedix Corp.
K963645	HERPES GROUP IGG ELISA TEST SYSTEM	Feb 04, 1997	Substantially Equivalent	Armkel, LLC
K963282	SERAQUEST HSV IGG	Jan 22, 1997	Substantially Equivalent	Quest Intl., Inc.
K950670	IMMULITE HERPES I AND II IGG	Jun 21, 1996	Substantially Equivalent	Diagnostic Products Corp.
K953839	PREMIER HSV PLUS	May 23, 1996	Substantially Equivalent	Meridian Diagnostics, Inc.
K925208	ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION	Dec 28, 1992	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K922334	BARTELS HERPES SIMPLEX VIRUS 1 IGM EIA	Dec 15, 1992	Substantially Equivalent	Baxter Diagnostics, Inc.
K922333	BARTELS HERPES SIMPLEX VIRUS 2 IGM EIA	Dec 15, 1992	Substantially Equivalent	Baxter Diagnostics, Inc.
K922759	HSV-2 IGM ELISA TEST--MODIFICATION	Oct 05, 1992	Substantially Equivalent	Gull Laboratories, Inc.
K922758	HSV-1 IGM ELISA TEST -- MODIFICATION	Oct 05, 1992	Substantially Equivalent	Gull Laboratories, Inc.
K922583	BARTELS HERPES SIMPLEX VIRUS 2 IGG EIA	Sep 28, 1992	Substantially Equivalent	Baxter Diagnostics, Inc.
K922584	BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA	Sep 18, 1992	Substantially Equivalent	Baxter Diagnostics, Inc.
K915551	ORTHO HSV ANTIGEN ELISA TEST	Apr 22, 1992	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K910955	HSV-1 IGM ELISA TEST	May 28, 1991	Substantially Equivalent	Gull Laboratories, Inc.
K910954	HSV-1 IGG ELISA TEST	May 28, 1991	Substantially Equivalent	Gull Laboratories, Inc.
K910953	HSV-2 IGM ELISA TEST	May 28, 1991	Substantially Equivalent	Gull Laboratories, Inc.
K910952	HSV-2 IGG ELISA TEST	May 28, 1991	Substantially Equivalent	Gull Laboratories, Inc.
K910499	IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS	May 01, 1991	Substantially Equivalent	Vitek Systems, Inc.
K903926	KODAK SURECELL HERPES (HSV) CONTROL FLUID SET	Sep 17, 1990	Substantially Equivalent	Eastman Kodak Company
K903070	SEROCARD HSV IGG ANTIBODY TEST KIT	Aug 09, 1990	Substantially Equivalent	Disease Detection International, Inc.
K900713	HERPTRAN CONCENTRATE	May 11, 1990	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K871877	IDEIA HERPES SIMPLEX VIRUS TEST	Nov 17, 1989	Substantially Equivalent	Boots-Celltech Diagnostics, Inc.
K884246	MODIFIED DDI SEROCARD HERPES IGG TEST KIT	Apr 10, 1989	Substantially Equivalent	Disease Detection International, Inc.
K884680	KODAK SURECELL HERPES (HSV) TEST KIT	Feb 16, 1989	Substantially Equivalent	Eastman Kodak Company
K843077	ELISA FOR HERPES SIMPLEX VIRUS	Jun 21, 1985	Substantially Equivalent	Scientific Research
K843622	ABBOTT HSV EIA	May 20, 1985	Substantially Equivalent	Abbott Laboratories
K834449	HSV ANTIGEN ELISA KIT	May 02, 1984	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K822883	HERPELISA KIT	Jul 26, 1983	Substantially Equivalent	M.A. Bioproducts
K802526	TEST KIT FOR DETECTION OF HERPES SIMPLEX	Feb 09, 1981	Substantially Equivalent	Bartels & Stout, Inc.