# K071510: Herpeselect Express Igg, Herpeselect Express Controls, Models RT0920G, RT0950

- Pathway: 510(k) (Traditional)
- Applicant: Focus Diagnostics, Inc.
- Decided: Sep 24, 2007 after 112 days
- Product code: MXJ (Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1)
- Device class: 2
- Regulation: 21 CFR 866.3305
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) HerpeSelect 1 and 2 Immunoblot IgG: named in the summary without a submission number
- (no number) HerpeSelect-2 ELISA IgG: named in the summary without a submission number

## Indications for use
HerpeSelect® Express is a rapid test intended for qualitatively detecting the presence or absence of human IgG class antibodies to herpes simplex virus type 2 (HSV-2) in human whole blood (venous or capillary) or serum. The test is indicated for testing sexually active adults or pregnant women to aid in the presumptive diagnosis of HSV-2 infection. The HerpeSelect® Express IgG device has not been established for use in the pediatrics population, for neonatal screening, or for testing immunocompromised patients. This kit is not intended for self-testing, and this test is neither FDA cleared nor approved for testing blood or plasma donors.

Source page: https://510kreport.com/device/K071510
Methodology: https://510kreport.com/methodology