# K162274: Solana Strep Complete Assay

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corporation
- Decided: Oct 25, 2016 after 74 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.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
The Solana® Strep Complete Assay is a rapid in vitro diagnostic test, using isothermal amplification technology (helicase-dependent amplification, HDA), for the qualitative detection and differentiation of Streptococcus pyogenes (Group A β-hemolytic Streptococcus) and Streptococcus dysgalactiae (pyogenic Group C and G β-hemolytic Streptococcus) nucleic acids isolated from throat swab specimens obtained from patients with signs and symptoms of pharyngitis, such as sore throat. The Solana® Strep Complete Assay is intended for use only with the the Solana® instrument.

Source page: https://510kreport.com/device/K162274
Methodology: https://510kreport.com/methodology