# K172509: Sentosa SA201 HSV 1/2 Qualitative PCR Test

- Pathway: 510(k) (Traditional)
- Applicant: Vela Diagnostics USA, Inc.
- Decided: Feb 1, 2018 after 164 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 4.

## Indications for use
The Sentosa® SA201 HSV-l/2 PCR Test is a real-time PCR-based qualitative in vitro diagnostic test for detection and differentiation of Herpes Simplex Virus (HSV-l and HSV-2) DNA from male and female skin lesions from anogenital or oral sites. The test is intended for use as an aid in diagnosis of herpes infection in symptomatic patients. Warning: The Sentosa® SA201 HSV-l/2 PCR Test is not FDA cleared for use with cerebrospinal fluid (CSF). The test is not intended to be used for prenatal screening.

Source page: https://510kreport.com/device/K172509
Methodology: https://510kreport.com/methodology