# K172126: Xpert Xpress Strep A

- Pathway: 510(k) (Traditional)
- Applicant: Cepheid
- Decided: Sep 25, 2017 after 73 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: 2 (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 4.

## Recalls of this device
- Apr 24, 2023 · Class II · Z-0215-2024: pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results.
- Apr 24, 2023 · Class II · Z-0216-2024: pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results.

## Indications for use
The Xpert Xpress Strep A Assay, performed on the GeneXpert Instrument Systems, is a rapid, qualitative in vitro diagnostic test for the detection of Streptococcus pyogenes (Group A beta-hemolytic Streptococcus, Strep A) in throat swab specimens from patients with signs and symptoms of pharyngitis. The Xpert Xpress Strep A Assay utilizes an automated real-time polymerase chain reaction (PCR) to detect Streptococcus pyogenes DNA.

Source page: https://510kreport.com/device/K172126
Methodology: https://510kreport.com/methodology