HerpeSelect Express IgG, HerpeSelect Express Controls, Models RT0920G, RT0950
by Focus Diagnostics, Inc. 510(k)
Active
510(k) K071510
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK071510 | Date24 Sep 2007 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- MXJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3305
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
HerpeSelect Express IgG is an enzyme-linked immunosorbent assay (ELISA) for qualitatively detecting human IgG antibodies to herpes simplex virus type 2 (HSV-2) in human whole blood (venous or capillary) or serum. It is designed to aid in the presumptive diagnosis of HSV-2 infection by identifying antibody presence or absence, supporting clinical assessment in sexually active adults or pregnant women.
The device is supplied as a rapid diagnostic kit, including controls (RT0950) and test models (RT0920G), and is intended for single-use in laboratory or point-of-care settings. It is classified under FDA regulation 866.3305 as an enzyme-linked immunosorbent assay for HSV-1, with a 510(k) clearance (K071510) under the Traditional pathway. No MRI safety or sterility specifications are noted in the regulatory data.
Other devices from Focus Diagnostics, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of samples can the HerpeSelect Express IgG test analyze, and how is it intended to be used in clinical settings?
The HerpeSelect Express IgG test is designed to qualitatively detect human IgG antibodies to herpes simplex virus type 2 (HSV-2) in human whole blood (venous or capillary) or serum. It aids in presumptive diagnosis by identifying whether antibodies are present or absent, helping clinicians assess HSV-2 infection risk in sexually active adults or pregnant women. The test is supplied as a rapid diagnostic kit for use in laboratory or point-of-care settings and is intended for single-use only.
Are the HerpeSelect Express IgG test and its controls available in multiple models, and how are they packaged?
Yes, the HerpeSelect Express IgG test is available in two models: RT0920G (test kit) and RT0950 (controls). Both are supplied as part of a rapid diagnostic kit, meaning they are designed for single-use and intended to be used together in a laboratory or point-of-care environment. The kit includes everything necessary for testing, including the test models and controls.
Is the HerpeSelect Express IgG test reusable, and what storage or handling considerations should be noted?
The HerpeSelect Express IgG test is intended for single-use only, meaning each kit should not be reused after a single test. While the regulatory data does not specify sterility requirements, standard laboratory practices for ELISA-based tests should be followed to ensure sample integrity. Storage conditions are not detailed in the provided data, but it is generally recommended to follow the manufacturer’s guidelines (Focus Diagnostics, Inc.) for optimal performance and shelf life.
What regulatory pathway was used for FDA clearance of the HerpeSelect Express IgG test, and what medical specialty does it fall under?
The HerpeSelect Express IgG test received FDA clearance through the Traditional 510(k) pathway under the Microbiology advisory committee (MI). It is classified under FDA regulation 866.3305 and is intended for use in Microbiology settings, specifically for enzyme-linked immunosorbent assays related to herpes simplex virus detection. The clearance number is K071510, and the product code is MXJ.