510(k) · Cleared
ClearedXpect Influenza a/B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Remel, Inc. · PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Cleared on Jul 17, 2003 after a 59-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Jul 17, 2003
- Review
- 59 days
- Class
- Class II
- Product code
- PSZ
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 4 citing it directly.
- This deviceK031565 Xpect Influenza a/BRemel, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK042472 BD Directigen EZ Flu a + BBecton, Dickinson & CO · 2005
- Descendant · cites it directly · 1 of its ownK041626 Immunocard Stat! Flu a & BMeridian Bioscience, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK131804 Remel Xpect Flu a&BRemel, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK101461 BD Directigen EX Flu a+BBecton, Dickinson and Company · 2010
- Descendant · 2 generations on · 0 of its ownK101529 BD Directigen EZ Flu a+B AssayBecton, Dickinson & CO · 2010
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K042472BD Directigen EZ Flu a + BBecton, Dickinson & CO · 2005 · cites it directly2descendants
- K041626Immunocard Stat! Flu a & BMeridian Bioscience, Inc. · 2005 · cites it directly1descendant
- K131804Remel Xpect Flu a&BRemel, Inc. · 2013 · cites it directly0descendants
- K101461BD Directigen EX Flu a+BBecton, Dickinson and Company · 2010 · 2 generations on0descendants
- K101529BD Directigen EZ Flu a+B AssayBecton, Dickinson & CO · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031565 | Xpect Influenza a/B | Remel, Inc. | 2003 | — |
| +1 | K042472 | BD Directigen EZ Flu a + B | Becton, Dickinson & CO | 2005 | — |
| +1 | K041626 | Immunocard Stat! Flu a & B | Meridian Bioscience, Inc. | 2005 | — |
| +1 | K131804 | Remel Xpect Flu a&B | Remel, Inc. | 2013 | — |
| +2 | K101461 | BD Directigen EX Flu a+B | Becton, Dickinson and Company | 2010 | — |
| +2 | K101529 | BD Directigen EZ Flu a+B Assay | Becton, Dickinson & CO | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 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 |
|---|---|---|---|
| * | — | BD Directigen Flu A+B Named without a submission number |
What descends from it? (7)
4 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K042472 (Becton, Dickinson & CO, 2005) has gone furthest, with 2 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.
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?
REMEL’s XpectTM Flu A/B is a rapid in vitro immunochromatographic test for the direct, qualitative detection of influenza A and influenza B viral antigen (nucleoprotein) from nasal wash, nasal swab, and throat swab specimens from symptomatic patients. The test is intended as an aid in the rapid diagnosis of influenza A and influenza B viral infections. Negative tests should be confirmed by cell culture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031565 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031565: Xpect Influenza a/B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031565
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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