510(k) · Cleared
ClearedRemel Xpect Flu a&B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Remel, Inc. · GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Cleared on Jul 12, 2013 as substantially equivalent to K031565 (Remel, Inc., 2003) after a 23-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Jul 12, 2013
- Review
- 23 days
- Class
- Class I
- Product code
- GNX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K031565 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK031565 Xpect Influenza a/BRemel, Inc. · 2003
- This deviceK131804 Remel Xpect Flu a&BRemel, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031565 | Xpect Influenza a/B | Remel, Inc. | 2003 | — |
| 0 (this device) | K131804 | Remel Xpect Flu a&B | Remel, Inc. | 2013 | — |
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 GNX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K031565 | Xpect Influenza a/BSummary page 1…email: [email protected] Date Prepared: June 18, 2013 Device Trade Name: Remel Xpect® Flu A&B Predicate Device: Remel Xpect® Flu A&B (K031565; S&E July 17, 2003) Device Classification: 21 CFR 866.3330: Influenza virus serological reagents. Intended Use: Re… | 2003 |
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.
- 3 other devices also cite its predicate K031565.
How does its category compare?
All GNX devicesGNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · GNX
6in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · GNX
27in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GNX
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GNX
93in 2025
MAUDE reports naming product code GNX, 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 | — | 4 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 1 | — | 1 | 4 |
| 2013 | 6 | 27 | 0 | 0 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 36 |
| 2022 | 0 | — | 0 | 32 |
| 2023 | 0 | — | 0 | 61 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 93 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Remel Xpect® Flu A&B is a rapid in vitro immunochromatographic test for the direct, qualitative detection of influenza A and influenza B viral antigens (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. 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131804 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131804: Remel Xpect Flu 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/K131804
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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