# K172402: ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit

- Pathway: 510(k) (Traditional)
- Applicant: Luminex Corporation
- Decided: Oct 30, 2017 after 82 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN140005 (2014). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141338: Liat Strep a Assay, Iquum, Inc. (2014) Summary page 6.

## Recalls of this device
- Feb 20, 2019 · Class II · Z-2286-2019: Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impa

## Indications for use
The ARIES® Group A Strep Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Streptococcus pyogenes (Group A beta-hemolytic Streptococcus) in throat swab specimens from patients with signs and symptoms of pharyngitis. The ARIES® Group A Strep Assay can be used as an aid in the diagnosis of Group A Streptococcal pharyngitis. The assay is not intended to monitor treatment for Group A Streptococcus infections. The ARIES® Group A Strep Assay is indicated for use with ARIES® Systems.

Source page: https://510kreport.com/device/K172402
Methodology: https://510kreport.com/methodology