# K131804: Remel Xpect Flu a&B

- Pathway: 510(k) (Special)
- Applicant: Remel, Inc.
- Decided: Jul 12, 2013 after 23 days
- Product code: GNX (Antigens, Cf (Including Cf Control), Influenza Virus A, B, C)
- Device class: 1
- Regulation: 21 CFR 866.3330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K031565 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031565: Xpect Influenza a/B, Remel, Inc. (2003) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K131804
Methodology: https://510kreport.com/methodology