# K142156: Seegene Anyplex II HSV-1/2 Assay

- Pathway: 510(k) (Traditional)
- Applicant: Seegene
- Decided: Feb 13, 2015 after 191 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)
- K140198: Imdx HSV-1/2 for Abbott M2000, Intelligent Medical Devices, Inc. (2014) Summary page 5.

## Indications for use
The AnyplexTM II HSV-1/2 Assay is a real-time polymerase chain reaction (PCR)-based in vitro diagnostic test intended for the qualitative detection and differentiation of Herpes Simplex Virus Type-1 (HSV-1) and Herpes Simplex Virus Type-2 (HSV-2) DNA from female skin lesions from anogenital sites. The test is intended for use as an aid in the diagnosis of anogenital HSV infection in symptomatic patients. WARNING: The AnyplexTM II HSV-1/2 Assay is not indicated for use with cerebrospinal fluid (CSF). The assay is not intended to be used for prenatal screening.

Source page: https://510kreport.com/device/K142156
Methodology: https://510kreport.com/methodology