Virogen HSV Antibody Test

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K871426 ↗

FDA Product Code

GQO

Device Class

Class II

Regulation

21 CFR Part 866.3305

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• What clinical purpose does the Virogen HSV Antibody Test serve in a lab setting?

  The Virogen HSV Antibody Test detects antibodies to herpes simplex virus (HSV) types 1 and 2 in human serum, helping confirm past exposure or infection. It measures immune response levels to aid in diagnosing HSV-related conditions, though it is not intended for acute infection detection. Results require interpretation by trained personnel in clinical microbiology labs.

• Is the Virogen HSV Antibody Test single-use or reusable, and how should it be handled?

  The regulatory data does not explicitly state whether the test is single-use or reusable. Since it is classified as an antisera device and involves handling patient samples, standard laboratory protocols for assay kits should apply—typically treated as single-use to prevent cross-contamination. Always follow manufacturer instructions for proper disposal or reprocessing if reuse is permitted.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for users?

  The Virogen HSV Antibody Test received FDA clearance via a Traditional 510(k) pathway (K871426), determined to be *substantially equivalent* to a predicate device. This means the FDA reviewed it against existing, legally marketed devices under the same regulatory framework (microbiology, product code GQO). Users can rely on this clearance as evidence of compliance with FDA standards for serological assays, though they should verify any updates or recalls via the manufacturer or FDA databases.

• Are there any special storage requirements for the Virogen HSV Antibody Test?

  The provided data does not specify storage conditions, but as a serological assay, it likely requires refrigeration (typically 2–8°C) to maintain antigen stability. Always refer to the manufacturer’s instructions or accompanying documentation for precise storage guidelines, including protection from light or freeze-thaw cycles, which could compromise test accuracy.

• How is this test different from other HSV diagnostic tools, and who should use it?

  Unlike PCR or viral culture tests (which detect active infection), the Virogen HSV Antibody Test focuses on serological detection—identifying antibodies to confirm prior exposure or immunity. It is designed for use in clinical microbiology laboratories by trained personnel, such as lab technicians or medical technologists, to support epidemiological studies or retrospective diagnosis of HSV infections.