# K141173: Amplivue Gas Assay

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corporation
- Decided: Jul 24, 2014 after 79 days
- Product code: PGX (Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System)
- Device class: 2
- Regulation: 21 CFR 866.2680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN140005 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN140005: Lyra Direct Strep Assay, Quidel Corporation (2014). Our reading of the summary gave K133883, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN140005, Lyra Direct Strep Assay (Quidel Corporation), granted Apr 16, 2014; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Indications for use
The AmpliVue® GAS Assay is an in vitro diagnostic test for the qualitative detection of Group A β-hemolytic Streptococcus (Streptococcus pyogenes) nucleic acids isolated from throat swab specimens obtained from patients with signs and symptoms of pharyngitis, such as sore throat. The AmpliVue® GAS Assay is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.

Source page: https://510kreport.com/device/K141173
Methodology: https://510kreport.com/methodology