# DEN140005: Lyra Direct Strep Assay

- Pathway: De Novo (Post-NSE)
- Applicant: Quidel Corporation
- Decided: Apr 16, 2014 after 22 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
No predicates in its family tree.
23 later devices descend from it; 6 cite it directly.
1 of 24 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K141757: Alere I Strep a (2015), 8 descendants of its own
- K141338: Liat Strep a Assay (2014), 8 descendants of its own
- K151690: Alere i Instrument, Alere i Influenza A & B, Alere i Strep A (2015), 4 descendants of its own
- 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
- K173653: Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit (2018), 3 descendants of its own

Source page: https://510kreport.com/device/DEN140005
Methodology: https://510kreport.com/methodology