# K141338: Liat Strep a Assay

- Pathway: 510(k) (Traditional)
- Applicant: Iquum, Inc.
- Decided: Nov 4, 2014 after 167 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.
8 later devices descend from it; 5 cite it directly.
0 of 10 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.

## Most influential descendants
- 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 (2020), 3 descendants of its own
- K210234: cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System (2021), 1 descendant of its own
- K260047: cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190) (2026), 0 descendants of its own
- K213822: cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System (2022), 0 descendants of its own
- K201269: Accula Strep A Test (2020), 0 descendants of its own

## Indications for use
The Liat™ Strep A Assay, performed on the Liat™ Analyzer, 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 Liat™ 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/K141338
Methodology: https://510kreport.com/methodology