# K260333: LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit

- Pathway: 510(k) (Dual Track)
- Applicant: Diasorin Molecular, LLC
- Decided: Jun 15, 2026 after 133 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: 2 generations back to DEN140005 (2014). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143651: Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack, Focus Diagnostics, Inc. (2015) Summary page 7.

## Indications for use
LIAISON NES Group A Strep is a real-time PCR assay intended for use on the LIAISON NES instrument for the in vitro qualitative detection of Streptococcus pyogenes, Group A Streptococcus (GAS) bacterial nucleic acid in throat swab specimens freshly collected from human patients with signs and symptoms of pharyngitis. This test is intended for use as an aid in the rapid diagnosis of Group A Streptococcus bacterial infections. The LIAISON NES Group A Strep Control Swab Kit is intended to be used as positive and negative controls with the LIAISON NES Group A Strep assay for use on the LIAISON NES instrument. These controls are not intended for use with other assays or systems.

Source page: https://510kreport.com/device/K260333
Methodology: https://510kreport.com/methodology