# K982429: Zstatflu Test for Influenza Types a and B Viruses

- Pathway: 510(k) (Traditional)
- Applicant: Zymetx, Inc.
- Decided: Aug 25, 1998 after 43 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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 no predicate by number.

## Most influential descendants
- K041626: Immunocard Stat! Flu a & B (2005), 1 descendant of its own
- K071657: Tru Flu (2007), 0 descendants of its own

## Indications for use
The ZstatFlu® Test for Influenza Type A and B Viruses is an endogenous viral-encoded enzyme assay (EVEA) and is intended for use in the qualitative determination of influenza types A and B from throat swab specimens. The ZstatFlu® Test for Influenza Type A and B Viruses is not intended for the detection of influenza C. This test is indicated for the direct testing of patients presenting with influenza-like illnesses.

Source page: https://510kreport.com/device/K982429
Methodology: https://510kreport.com/methodology