# K142738: artus HSV-1/2 QS-RGQ MDx Kit

- Pathway: 510(k) (Traditional)
- Applicant: Qiagen
- Decided: Dec 19, 2014 after 87 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.
1 of 4 devices in its family (counting itself) has 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 4.

## Most influential descendants
- K150962: Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack (2015), 0 descendants of its own

## Indications for use
The artus HSV-1/2 QS-RGQ MDx Kit is an in vitro real-time PCR DNA amplification assay performed on the QIAsymphony RGQ MDx system for the direct qualitative detection and differentiation of herpes simplex virus (HSV-1 and HSV-2) DNA in genital or oral vesicular lesions from male and female patients suspected of HSV infection. The assay is intended for use as an aid in diagnosis of HSV infection in symptomatic patients. Warning: The artus HSV-1/2 QS-RGQ MDx Kit is not FDA-cleared for use with cerebrospinal fluid (CSF) or for prenatal screening.

Source page: https://510kreport.com/device/K142738
Methodology: https://510kreport.com/methodology