510(k) · Cleared
ClearedSofia Strep A+ FIA, Sofia 2 Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quidel Corporation · GTY Antigens, All Groups, Streptococcus Spp.
Cleared on Dec 21, 2017 as substantially equivalent to K141775 (Quidel Corporation, 2014) after a 174-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Dec 21, 2017
- Review
- 174 days
- Class
- Class I
- Product code
- GTY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K011097 (2001). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK011097 Quickvue Dipstick Strep aQuidel Corp. · 2001 · Recalled
- 2 generations backK123793 Sofia Strep a FiaQuidel Corporation · 2013
- 1 generation backK141775 Sofia (R) Strep a+ FiaQuidel Corporation · 2014 · Recalled
- This deviceK171976 Sofia Strep A+ FIA, Sofia 2 AnalyzerQuidel Corporation · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011097 | Quickvue Dipstick Strep a | Quidel Corp. | 2001 | 2 |
| −2 | K123793 | Sofia Strep a Fia | Quidel Corporation | 2013 | — |
| −1 | K141775 | Sofia (R) Strep a+ Fia | Quidel Corporation | 2014 | 1 |
| 0 (this device) | K171976 | Sofia Strep A+ FIA, Sofia 2 Analyzer | Quidel Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
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 GTY? 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 GTY device
- #1 K260342 AllTest Strep A Rapid Testscore 11.9 · 3 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K141775 | Sofia (R) Strep a+ FiaSummary page 7…e 5-3 5.10. Substantial Equivalence Information: 1. Predicate Device Name: Sofia Strep A+ FIA performed on Sofia 2. Predicate 510(k) Number: K141775 3. Comparison with Predicate: Similarities and Differences Item… | 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?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 3 of the 4 ancestors have a recall of any class.
How does its category compare?
All GTY devicesGTY Antigens, All Groups, Streptococcus Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · GTY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GTY
Too few GTY 510(k)s in any year since 2007 to give a median.
Recalls per year · GTY
4in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GTY
94in 2025
MAUDE reports naming product code GTY, 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 | 1 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 4 | 3 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 37 |
| 2022 | 1 | — | 0 | 32 |
| 2023 | 0 | — | 0 | 44 |
| 2024 | 0 | — | 0 | 41 |
| 2025 | 1 | — | 0 | 94 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Sofia Strep A+ FIA detects Group A Streptococcal antigens from throat swabs from patients with signs and symptoms of pharyngitis, such as sore throat. All negative test results should be confirmed by either bacterial culture or an FDA-cleared molecular assay because negative results do not preclude Group A Strep infection and should not be used as the sole basis for treatment. The test is intended for professional and laboratory use as an aid in the diagnosis of Group A Streptococcal infection.
The Sofia Strep A+ FIA may be used with Sofia or Sofia 2.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K171976 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171976: Sofia Strep A+ FIA, Sofia 2 Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171976
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