510(k) · Cleared
Recalled · Class II · 2022Sofia (R) Strep a+ Fia
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 16, 2014 as substantially equivalent to K123793 (Quidel Corporation, 2013) after a 168-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 16, 2014
- Review
- 168 days
- Class
- Class I
- Product code
- GTY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011097 (2001). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK011097 Quickvue Dipstick Strep aQuidel Corp. · 2001 · Recalled
- 1 generation backK123793 Sofia Strep a FiaQuidel Corporation · 2013
- This deviceK141775 Sofia (R) Strep a+ FiaQuidel Corporation · 2014
- Descendant · cites it directly · 0 of its ownK171976 Sofia Strep A+ FIA, Sofia 2 AnalyzerQuidel Corporation · 2017
Most influential descendants
Showing 1 of 1 · See all- K171976Sofia Strep A+ FIA, Sofia 2 AnalyzerQuidel Corporation · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011097 | Quickvue Dipstick Strep a | Quidel Corp. | 2001 | 2 |
| −1 | K123793 | Sofia Strep a Fia | Quidel Corporation | 2013 | — |
| 0 (this device) | K141775 | Sofia (R) Strep a+ Fia | Quidel Corporation | 2014 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K123793 | Sofia Strep a FiaSummary page 5…Sofia Common Name: Strep A immunological test system and Fluorometer Predicate Devices: Sofia Strep A FIA for use with Sofia, K123793 Device Classification/Name: 21 CFR 866.3740 / Streptococcus Group A serological re… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171976 | Sofia Strep A+ FIA, Sofia 2 Analyzer | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 25, 2022 | Class II | Z-1598-2022 | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 12.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K171976 (Quidel Corporation, 2017) has gone furthest, with 0 descendants of its own.
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. 2014, 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 bacterial culture 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141775 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141775: Sofia (R) Strep a+ Fia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141775
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