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IDEIA Herpes Simplex Virus Test

by Boots-Celltech Diagnostics, Inc. 510(k)

Active United States

510(k) K871877

Overview

The IDEIA Herpes Simplex Virus Test is an enzyme linked immunosorbent assay (ELISA) for the detection of herpes simplex virus antigen in clinical specimens. It utilizes monoclonal antibodies to detect HSV-1 and HSV-2 antigen and employs an enzyme amplification system to enhance the test signal.

This in vitro diagnostic device is supplied non-sterile and intended for use in clinical laboratory settings. It is a Class II medical device with FDA 510(k) clearance (K871877), determined to be substantially equivalent to a legally marketed predicate device. The test is regulated under regulation number 866.3305 and product code LGC, and is intended for microbiological use in the detection of herpes simplex virus antigens.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK871877 Date17 Nov 1989ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LGC
Device Class
Class II
Regulation
21 CFR Part 866.3305
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the IDEIA Herpes Simplex Virus Test used for?

    The IDEIA Herpes Simplex Virus Test is used to detect herpes simplex virus antigen in clinical specimens. It employs monoclonal antibodies specific to HSV-1 and HSV-2 and an enzyme amplification system to enhance signal detection, making it suitable for microbiological diagnosis in clinical laboratory settings.

  • How is the IDEIA Herpes Simplex Virus Test supplied and is it sterile?

    The IDEIA Herpes Simplex Virus Test is supplied non-sterile and is intended for use in clinical laboratory settings. As an in vitro diagnostic ELISA kit, it does not require sterility since it is used outside the body on processed specimens such as serum or plasma.

  • Is the IDEIA Herpes Simplex Virus Test reusable or single-use?

    The IDEIA Herpes Simplex Virus Test is designed for single-use. Each test kit is intended for one diagnostic run to detect HSV antigens in clinical specimens, and reagents should not be reused to avoid cross-contamination and ensure accurate results.

  • What regulatory pathway was used for the IDEIA Herpes Simplex Virus Test?

    The IDEIA Herpes Simplex Virus Test received FDA 510(k) clearance under submission K871877, determined to be substantially equivalent to a legally marketed predicate device. It is classified as a Class II medical device under regulation number 866.3305 and product code LGC.