510(k) · Cleared
ClearedSolana Strep Complete Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quidel Corporation · PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
Cleared on Oct 25, 2016 as substantially equivalent to DEN140005 (Quidel Corporation, 2014) after a 74-day review. Its family tree reaches back 1 generation to 2014.
- Decided
- Oct 25, 2016
- Review
- 74 days
- Class
- Class II
- Product code
- PGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN140005 (2014). No later device cites it as a predicate yet.
- Root · 1 generation backDEN140005 Lyra Direct Strep AssayQuidel Corporation · 2014
- This deviceK162274 Solana Strep Complete AssayQuidel Corporation · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN140005 | Lyra Direct Strep Assay | Quidel Corporation | 2014 | — |
| 0 (this device) | K162274 | Solana Strep Complete Assay | Quidel Corporation | 2016 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PGX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PGX device
- #1 K260047 cobas Strep A Nucleic acid test for use on the…score 14.0 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN140005 | Lyra Direct Strep Assay 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. | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 5 other devices also cite its predicate DEN140005.
How does its category compare?
All PGX devicesPGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PGX
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · PGX
85in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PGX
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PGX
1in 2022
MAUDE reports naming product code PGX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 3 | — | 0 | 0 |
| 2015 | 3 | 85 | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 2 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162274 · printed Nov 4, 2026
Cite this page
510(k) Report. “K162274: Solana Strep Complete Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K162274
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026