# K152353: SeraQuest HSV Type 2 Specific IgG

- Pathway: 510(k) (Traditional)
- Applicant: Quest International, Inc.
- Decided: May 13, 2016 after 267 days
- Product code: MYF (Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) HSV 1 and 2 Immunoblot IgG test: named in the summary without a submission number

## Most influential descendants
- K181514: SeraQuest HSV Type 2 Specific IgG (2019), 0 descendants of its own

## Indications for use
Intended Use: For In Vitro Diagnostic Use Only. The SeraQuest HSV Type 2 Specific IgG assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative detection of human IgG antibodies to type 2 herpes simplex virus (HSV) in human serum. The test is indicated for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-2 infection. The predictive value of a positive or negative result depends on the prevalence of HSV-2 infection in the population and the pre-test likelihood of HSV-2 infection. The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for immunocompromised patients, pediatric patients or matrices other than human serum. For In Vitro Diagnostic Use Only. A positive result indicates previous exposure to Type 2 Herpes Simplex Virus.

Source page: https://510kreport.com/device/K152353
Methodology: https://510kreport.com/methodology