# K140029: Amiplivue HSV 1&2 Assay

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corporation
- Decided: Mar 26, 2014 after 79 days
- Product code: OQO (Herpes Simplex Virus Nucleic Acid Amplification Assay)
- 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
Longest line of descent: 3 generations back to K971662 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111951: Isoamp HSV Assay, Biohelix Corporation (2011) Summary page 2.

## Indications for use
The AmpliVue HSV 1+2 Assay is an in vitro diagnostic test for the direct, qualitative detection and differentiation of Herpes Simplex Virus 1 (HSV-1) and Herpes Simplex Virus 2 (HSV-2) DNA in cutaneous or mucocutaneous lesion specimens from symptomatic patients. The test is intended for use as an aid in diagnosis of HSV infection in symptomatic patients. Warning: The AmpliVue HSV 1+2 Assay is not FDA cleared for use with cerebrospinal fluid (CSF). The assay is not intended for prenatal screening.

Source page: https://510kreport.com/device/K140029
Methodology: https://510kreport.com/methodology