Ortho HSV Antigen ELISA Test
by Ortho Diagnostic Systems, Inc. 510(k)
Active
510(k) K854488
Overview
The Ortho HSV Antigen ELISA Test is an in vitro diagnostic device classified as an Antigen Test for Herpesvirus hominis 1,2 under the nomenclature for microbiology assays. It detects HSV-1 and HSV-2 antigens in clinical specimens using enzyme-linked immunosorbent assay (ELISA) technology, aiding in the rapid identification of herpes simplex virus infections.
This test is supplied as a kit for laboratory use and is intended for single-use only. It is regulated under 21 CFR 866.3305 and has received FDA 510(k) clearance (K854488, K915551, K925208) as a substantially equivalent device to a predicate. The product code assigned is GQN, and it is distributed by Ortho Diagnostic Systems, Inc., with no indication of sterility or MRI compatibility in the regulatory data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK854488 | Date4 Feb 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GQN
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3305
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Ortho Diagnostic Systems, Inc.
Questions
What clinical purpose does the Ortho HSV Antigen ELISA Test serve in a laboratory setting?
The Ortho HSV Antigen ELISA Test is designed to detect antigens for Herpes Simplex Virus types 1 and 2 (HSV-1 and HSV-2) in clinical specimens. By using enzyme-linked immunosorbent assay (ELISA) technology, it helps laboratories rapidly identify active herpes simplex virus infections, aiding in accurate diagnosis and patient management.
Is this test intended for repeated use, or is it meant to be used once and then discarded?
The Ortho HSV Antigen ELISA Test is explicitly supplied as a kit for single-use only. This ensures consistency in test results and maintains the integrity of the assay components, which could be compromised if reused.
How is this test kit supplied, and what should I expect when ordering it?
The kit is distributed by Ortho Diagnostic Systems, Inc. and is intended for laboratory use. It is supplied as a complete ELISA test system, including all necessary reagents and components for performing the assay. The exact contents may vary, but it is designed for single-use per test run, so you’ll receive enough materials for multiple individual tests in a single kit.
Does this test require any special handling or storage conditions?
While the provided regulatory data does not specify exact storage conditions, ELISA test kits like this typically require refrigeration (between 2°C and 8°C) to maintain stability and performance. Always refer to the included instructions for use for precise storage guidelines, as improper handling could affect test accuracy.
What regulatory pathway was followed for this device’s clearance, and what does that mean for its use?
The Ortho HSV Antigen ELISA Test received FDA 510(k) clearance through a traditional review process, with the device classified as substantially equivalent to a predicate under 21 CFR 866.3305. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared device, ensuring it meets safety and effectiveness standards for detecting HSV-1 and HSV-2 antigens in clinical specimens.