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HSV-1 IgM ELISA Test -- Modification

by Gull Laboratories, Inc. 510(k)

Active United States

510(k) K922758

Overview

This device is an Enzyme Linked Immunoabsorbent Assay (ELISA) for detecting non-specific IgM antibodies to Herpes Simplex Virus Type 1 (HSV-1). It functions as an in vitro diagnostic test to aid in the serological identification of recent HSV-1 infections by measuring IgM antibody levels in human serum or plasma samples.

The HSV-1 IgM ELISA Test -- Modification is intended for use in clinical microbiology laboratories and is supplied as a reagent kit for single-use testing. It is classified as a Class II device under FDA regulation 866.3305 and has received FDA 510(k) clearance (K922758) as substantially equivalent to a predicate device. The test requires standard laboratory equipment and adheres to aseptic handling procedures for reagent preparation and sample processing.

AI-generated from registry data, 19 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 NumberK922758 Date5 Oct 1992ClearedStatusActive

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 purpose of the HSV-1 IgM ELISA Test -- Modification?

    This device is an in vitro diagnostic test that detects non-specific IgM antibodies to Herpes Simplex Virus Type 1 (HSV-1). It aids in the serological identification of recent HSV-1 infections by measuring IgM antibody levels in human serum or plasma samples.

  • How is the HSV-1 IgM ELISA Test supplied and what are its handling requirements?

    The test is supplied as a reagent kit for single-use testing in clinical microbiology laboratories. It requires standard laboratory equipment and must be handled aseptically during reagent preparation and sample processing.

  • What is the regulatory classification of this device?

    The HSV-1 IgM ELISA Test is classified as a Class II device under FDA regulation 866.3305. It has received FDA 510(k) clearance (K922758) as substantially equivalent to a predicate device.

  • What types of samples can be tested with this device?

    The HSV-1 IgM ELISA Test is designed to detect IgM antibodies in human serum or plasma samples, making it suitable for serological testing in clinical laboratory settings.