# K031565: Xpect Influenza a/B

- Pathway: 510(k) (Traditional)
- Applicant: Remel, Inc.
- Decided: Jul 17, 2003 after 59 days
- Product code: PSZ (Devices Detecting Influenza A, B, And C Virus Antigens)
- Device class: 2
- Regulation: 21 CFR 866.3328
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BD Directigen Flu A+B: named in the summary without a submission number

## Most influential descendants
- K042472: BD Directigen EZ Flu a + B (2005), 2 descendants of its own
- K041626: Immunocard Stat! Flu a & B (2005), 1 descendant of its own
- K131804: Remel Xpect Flu a&B (2013), 0 descendants of its own
- K101461: BD Directigen EX Flu a+B (2010), 0 descendants of its own
- K101529: BD Directigen EZ Flu a+B Assay (2010), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K031565
Methodology: https://510kreport.com/methodology