# K011684: Influenza a/B Rapid Test, Cat NO 2158 663

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Nov 30, 2001 after 184 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
Longest line of descent: 1 generation back to K993048 (1999). 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)
- K993048: Roche Diagnostics Influenza a/B Rapid Test, Roche Diagnostics Corp. (1999) Summary page 1.

## Indications for use
The Influenza A/B Rapid Test is a qualitative inmunoassay for the rapid detection of Influenza A/B viral antigens from throat swab or nasal swab specimens. This test is intended for professional in vitro diagnostic use to aid in the diagnosis of Influenza infections, and to gather epidemiological information for detection of Influenza outbreaks. When used for diagnosis, negative assay results should be confirmed by cell culture. This assay does not detect the presence of Influenza C viral antigens.

Source page: https://510kreport.com/device/K011684
Methodology: https://510kreport.com/methodology