Product Code: MXJ FDA class 2 21 CFR 866.3305

Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1

Microbiology

The Enzyme Linked Immunosorbent Assay (ELISA) for Herpes Simplex Virus Type 1 (HSV-1) is an in vitro diagnostic test used to detect antibodies against HSV-1 in patient serum or plasma, supporting the diagnosis of HSV-1 infection. It is intended for laboratory use and aids in the serological differentiation of HSV-1 from HSV-2. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 866.3305 (Microbiology specialty).

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FEI Numbers

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Basic Information

Product Code: MXJ
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 20 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K213987	ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls	Sep 20, 2023	Substantially Equivalent	Biokit, S.A.
K220923	Elecsys HSV-1 IgG (08948844160)	Oct 12, 2022	Substantially Equivalent	Roche Diagnostics
K181333	ADVIA Centaur Herpes-1 IgG	Aug 23, 2018	Substantially Equivalent	Biokit, S.A.
K162276	SeraQuest Herpes Type 1 Specific IgG	Oct 01, 2016	Substantially Equivalent	Quest International, Inc.
K143236	Theranos Herpes Simplex Virus-1 IgG Assay	Jul 02, 2015	Substantially Equivalent	Theranos, Inc.
K131334	HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST	Feb 28, 2014	Substantially Equivalent	Gold Standard Diagnostics
K120625	ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV	Jul 25, 2012	Substantially Equivalent	Roche Diagnostics
K120959	BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT	Jun 22, 2012	Substantially Equivalent	Bio-Rad Laboratories
K103363	ZEUS ELISA HSV GC-I IGG TEST SYSTEM	Apr 26, 2011	Substantially Equivalent	Zeus Scientific, Inc.
K090409	BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM	May 08, 2009	Substantially Equivalent	Bio-Rad Laboratories
K081685	LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG	Nov 18, 2008	Substantially Equivalent	DiaSorin, Inc.
K072178	ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM	May 30, 2008	Substantially Equivalent	Zeus Scientific, Inc.
K071511	PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G	Oct 05, 2007	Substantially Equivalent	Focus Diagnostics, Inc.
K071510	HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950	Sep 24, 2007	Substantially Equivalent	Focus Diagnostics, Inc.
K062543	HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G	Feb 01, 2007	Substantially Equivalent	Focus Diagnostics, Inc.
K033105	CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT	Jul 13, 2004	Substantially Equivalent	Trinity Biotech USA
K021486	HERPESELECT 2 ELISA IGG, MODEL ELO920G	Aug 01, 2002	Substantially Equivalent	Focus Technologies, Inc.
K021429	HERPESELECT 1 ELISA IGG, MODEL EL0910G	Jul 29, 2002	Substantially Equivalent	Focus Technologies, Inc.
K993754	HSV-1 ELISA IGG, MODEL EL0910G	Feb 09, 2000	Substantially Equivalent	Mrl Diagnostics
K984343	PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST	Jun 25, 1999	Substantially Equivalent	Meridian Diagnostics, Inc.