510(k) · Cleared
Recalled · Class II · 2026Quickvue Dipstick Strep a
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quidel Corp. · GTY Antigens, All Groups, Streptococcus Spp.
Cleared on May 8, 2001 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- May 8, 2001
- Review
- 27 days
- Class
- Class I
- Product code
- GTY
- Recalls
- 2
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK011097 Quickvue Dipstick Strep aQuidel Corp. · 2001
- Descendant · cites it directly · 2 of its ownK123793 Sofia Strep a FiaQuidel Corporation · 2013
- Descendant · 2 generations on · 1 of its ownK141775 Sofia (R) Strep a+ FiaQuidel Corporation · 2014 · Recalled
- Descendant · 3 generations on · 0 of its ownK171976 Sofia Strep A+ FIA, Sofia 2 AnalyzerQuidel Corporation · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011097 | Quickvue Dipstick Strep a | Quidel Corp. | 2001 | — |
| +1 | K123793 | Sofia Strep a Fia | Quidel Corporation | 2013 | — |
| +2 | K141775 | Sofia (R) Strep a+ Fia | Quidel Corporation | 2014 | 1 |
| +3 | K171976 | Sofia Strep A+ FIA, Sofia 2 Analyzer | Quidel Corporation | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123793 | Sofia Strep a Fia | 2013 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 6, 2026 | Class II | Z-2169-2026 | Under Investigation by firm | Product has the potential for false positive results |
| Jun 17, 2025 | Class II | Z-2545-2025 | Under Investigation by firm | Dipstick strep A test has potential for false positive results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K123793 (Quidel Corporation, 2013) has gone furthest, with 2 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.
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 | — |
https://510kreport.com/device/K011097 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011097: Quickvue Dipstick Strep a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011097
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026