510(k) · Cleared
Recalled · Class II · 2012Sofia Analyzer and Influenza a+B Fia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quidel Corp. · PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Cleared on Oct 24, 2011 after an 88-day review. The FDA summary names its predicate without a number. 8 later devices descend from it. It has been recalled once.
- Decided
- Oct 24, 2011
- Review
- 88 days
- Class
- Class II
- Product code
- PSZ
- Recalls
- 1
- Predicates
- 0
8 later devices descend from it, 3 citing it directly.
- This deviceK112177 Sofia Analyzer and Influenza a+B FiaQuidel Corp. · 2011
- Descendant · cites it directly · 4 of its ownK153012 Sofia Influenza A+B FIAQuidel Corporation · 2016
- Descendant · cites it directly · 3 of its ownK162438 Sofia Influenza A+B FIA on Sofia 2Quidel Corporation · 2017 · Recalled
- Descendant · cites it directly · 2 of its ownK123793 Sofia Strep a FiaQuidel Corporation · 2013
- Descendant · 2 generations on · 1 of its ownK180288 QuickVue Influenza A+BQuidel Corporation · 2018
- Descendant · 2 generations on · 1 of its ownK141775 Sofia (R) Strep a+ FiaQuidel Corporation · 2014 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K153012Sofia Influenza A+B FIAQuidel Corporation · 2016 · cites it directly4descendants
- K162438Sofia Influenza A+B FIA on Sofia 2Quidel Corporation · 2017 · cites it directly3descendants
- K123793Sofia Strep a FiaQuidel Corporation · 2013 · cites it directly2descendants
- K180288QuickVue Influenza A+BQuidel Corporation · 2018 · 2 generations on1descendant
- K141775Sofia (R) Strep a+ FiaQuidel Corporation · 2014 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K112177 | Sofia Analyzer and Influenza a+B Fia | Quidel Corp. | 2011 | — |
| +1 | K153012 | Sofia Influenza A+B FIA | Quidel Corporation | 2016 | — |
| +1 | K162438 | Sofia Influenza A+B FIA on Sofia 2 | Quidel Corporation | 2017 | 1 |
| +1 | K123793 | Sofia Strep a Fia | Quidel Corporation | 2013 | — |
| +2 | K180288 | QuickVue Influenza A+B | Quidel Corporation | 2018 | — |
| +2 | K141775 | Sofia (R) Strep a+ Fia | Quidel Corporation | 2014 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 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 PSZ? 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 PSZ device
- #1 K252283 Nano-Check Influenza A+B Testscore 14.9 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | — | 3M Rapid Detection Flu A+B Reader and Test Named without a submission number | |
| * | — | QuickVue Influenza A+B Test Named without a submission number |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 3, 2012 | Class II | Z-0819-2013 | Nonconforming Material/Component | Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B FIA kits because of false positive results which may lead to misdiagnosis. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K153012 (Quidel Corporation, 2016) has gone furthest, with 4 descendants of its own.
How does its category compare?
All PSZ devicesPSZ Devices Detecting Influenza A, B, And C Virus Antigens: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · PSZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PSZ
28in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PSZ
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PSZ
60in 2025
MAUDE reports naming product code PSZ, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 7 | 20 | 0 | 0 |
| 2010 | 5 | 29 | 0 | 0 |
| 2011 | 3 | 80 | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 8 | 28 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 4 | 27 | 0 | 0 |
| 2016 | 3 | 29 | 0 | 0 |
| 2017 | 3 | 200 | 0 | 0 |
| 2018 | 5 | 28 | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 2 | — | 1 | 5 |
| 2021 | 0 | — | 0 | 42 |
| 2022 | 0 | — | 1 | 10 |
| 2023 | 2 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 16 |
| 2025 | 2 | — | 0 | 60 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Sofia Influenza A+B FIA employs immunofluorescence to detect influenza A and influenza B viral nucleoprotein antigens in nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens taken directly from symptomatic patients. This qualitative test is intended for use as an aid in the rapid differential diagnosis of acute influenza A and influenza B viral infections. The test is not intended to detect influenza C antigens. A negative test…
Read the full statement (255 words)
The Sofia Influenza A+B FIA employs immunofluorescence to detect influenza A and influenza B viral nucleoprotein antigens in nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens taken directly from symptomatic patients. This qualitative test is intended for use as an aid in the rapid differential diagnosis of acute influenza A and influenza B viral infections. The test is not intended to detect influenza C antigens. A negative test is presumptive and it is recommended these results be confirmed by virus culture or an FDA-cleared influenza A and B molecular assay. Negative results do not preclude influenza virus infections and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.
Performance characteristics for influenza A and B were established during February through March 2011 when influenza viruses A/California/7/2009 (2009 Hi11\1), A/PerthI16I2009 (1-3N\2), and BlBrisbane/60/2008 (Victoria-Like) were the predominant influenza viruses in circulation according to the Morbidity and Mortality Weekly Report from the CDC entitled "Update: Influenza Activity--United States, 2010-2011 Season, and Composition of the 2011-2012 Influenza Vaccine". Performance characteristics may vary against other emerging influenza viruses.
If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Virus culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112177 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112177: Sofia Analyzer and Influenza a+B Fia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112177
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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