# K260047: cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190)

- Pathway: 510(k) (Traditional)
- Applicant: Roche Molecular Systems, Inc.
- Decided: Aug 28, 2026 after 233 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: 8 generations back to DEN070013 (2008). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200065: cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System, Roche Molecular Systems, Inc. (2020) Summary page 5.

## Indications for use
The cobas Strep A nucleic acid test for use on the cobas Liat System (cobas Strep A) is a qualitative in vitro diagnostic test for the detection of Streptococcus pyogenes (Group A β-hemolytic Streptococcus, Strep A) in throat swab specimens from patients with signs and symptoms of pharyngitis. The cobas Strep A assay utilizes nucleic acid purification and polymerase chain reaction (PCR) technology to detect Streptococcus pyogenes by targeting a segment of the Streptococcus pyogenes genome.

Source page: https://510kreport.com/device/K260047
Methodology: https://510kreport.com/methodology