510(k) · Cleared
ClearedClearview Exact II Influenza a & B Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inverness Medical, Inc. · PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Cleared on May 10, 2010 as substantially equivalent to K062109 (Binax, Inc., 2006) after a 279-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.
- Decided
- May 10, 2010
- Review
- 279 days
- Class
- Class II
- Product code
- PSZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001364 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK001364 BD Directigen Flu a+BBd Becton Dickinson Vacutainer Systems Preanalytic · 2000
- 1 generation backK062109 Binaxnow Influenza a & B TestBinax, Inc. · 2006 · Recalled
- This deviceK092349 Clearview Exact II Influenza a & B TestInverness Medical, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK103610 Clearview Exact II Influenza a & B TestAlere Scarborough, Inc D/B/A Binax, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK133637 Alere Influenza a & B TestAlere Scarborough, Inc D/B/A Binax, Inc. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001364 | BD Directigen Flu a+B | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2000 | — |
| −1 | K062109 | Binaxnow Influenza a & B Test | Binax, Inc. | 2006 | 2 |
| 0 (this device) | K092349 | Clearview Exact II Influenza a & B Test | Inverness Medical, Inc. | 2010 | — |
| +1 | K103610 | Clearview Exact II Influenza a & B Test | Alere Scarborough, Inc D/B/A Binax, Inc. | 2011 | — |
| +2 | K133637 | Alere Influenza a & B Test | Alere Scarborough, Inc D/B/A Binax, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 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? (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 |
|---|---|---|---|
| * | K062109 | Binaxnow Influenza a & B TestSummary page 1…K092349 To establish substantial equivalence to the predicate, the Clearview® Exact II Influenza A & B Test was compared to the BinaxNOW!O Influenza A & B Test (510(k) #K062109). SUBMITTER Binax, Inc., d/b/a Inverness Medical 10 Southgate Road Scarborough, Maine 04074 (207) 730-5739 (Office) (207) 730-571… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103610 | Clearview Exact II Influenza a & B Test | 2011 | 1 |
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 10 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K103610 (Alere Scarborough, Inc D/B/A Binax, Inc., 2011) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K062109.
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. 2010, 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 Clearview® Exact II Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasal swab specimens collected from symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. It is recommended that negative test results be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092349 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092349: Clearview Exact II Influenza a & B Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092349
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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