# K993048: Roche Diagnostics Influenza a/B Rapid Test

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Dec 20, 1999 after 101 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Biostar Flu OIA: named in the summary without a submission number

## Most influential descendants
- K011684: Influenza a/B Rapid Test, Cat NO 2158 663 (2001), 0 descendants of its own

## Indications for use
The Influenza A/B Rapid Test is a qualitative immunoassay for the rapid detection of Influenza A/B viral antigens from throat 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/K993048
Methodology: https://510kreport.com/methodology