# K111951: Isoamp HSV Assay

- Pathway: 510(k) (Traditional)
- Applicant: Biohelix Corporation
- Decided: Sep 27, 2011 after 81 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: 2 generations back to K971662 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100336: Multicode - RTX Herpes Simplex Virus 1 and 2 Kit, Model 3711, Eragen Biosciences (2010) Summary page 1.

## Most influential descendants
- K140029: Amiplivue HSV 1&2 Assay (2014), 0 descendants of its own

## Indications for use
The IsoAmp® HSV Assay isan in vitro diagnostic test for the direct, qualitative detection of herpes simplex virus (HSV-1 & HSV-2) DNA in male and female genital and oral lesions. The test isintended for use as an aid in diagnosis of HSV infection in symptomatic patients. Warning: The IsoAmp® HSV Assay is not FDA cleared for use with cerebrospinal fluid (CSF). The assay does not provide specific typing information to differentiate HSV-1 and HSV-2. The assay is not intended to be used for prenatal screening.

Source page: https://510kreport.com/device/K111951
Methodology: https://510kreport.com/methodology