510(k) · Cleared
ClearedInfluenza a/B Rapid Test, Cat NO 2158 663
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Cleared on Nov 30, 2001 as substantially equivalent to K993048 (Roche Diagnostics Corp., 1999) after a 184-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Nov 30, 2001
- Review
- 184 days
- Class
- Class II
- Product code
- PSZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993048 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK993048 Roche Diagnostics Influenza a/B Rapid TestRoche Diagnostics Corp. · 1999
- This deviceK011684 Influenza a/B Rapid Test, Cat NO 2158 663Roche Diagnostics Corp. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993048 | Roche Diagnostics Influenza a/B Rapid Test | Roche Diagnostics Corp. | 1999 | — |
| 0 (this device) | K011684 | Influenza a/B Rapid Test, Cat NO 2158 663 | Roche Diagnostics Corp. | 2001 | — |
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? (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 |
|---|---|---|---|
| * | K993048 | Roche Diagnostics Influenza a/B Rapid TestSummary page 1…including CF control), influenza virus A, B,C 3) Predicate We claim substantial equivalence to the previously cleared Roche Diagnostics device Influenza A/B Rapid Test (K993048). Continued on next page Roche Diagnostics Corporation 26 May 29, 2001 510(k) Summary, Continued 4) Device Desc… | 1999 |
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.
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.
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 Influenza A/B Rapid Test is a qualitative inmunoassay for the rapid detection of Influenza A/B viral antigens from throat swab or nasal swab specimens. This test is intended for professional in vitro diagnostic use to aid in the diagnosis of Influenza infections, and to gather epidemiological information for detection of Influenza outbreaks. When used for diagnosis, negative assay results should be confirmed by cell culture. This assay does not detect the presence of Influenza C viral antigens.
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/K011684 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011684: Influenza a/B Rapid Test, Cat NO 2158 663.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011684
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026