# K041626: Immunocard Stat! Flu a & B

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Bioscience, Inc.
- Decided: Mar 16, 2005 after 273 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: 4 generations back to K902609 (1990). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021649: Binax Now Flu a Test (27 Test), Binax Now Nasopharyngeal Swab Specimen Accesory Pack, Binax, Inc. (2002) Summary page 1.
- K021646: Binax Now Flu B Test (27 Test), Binax Now Nasopharyngeal Swab Specimen Accesory Pack, Binax, Inc. (2002) Summary page 1.
- K001364: BD Directigen Flu a+B, Bd Becton Dickinson Vacutainer Systems Preanalytic (2000) Summary page 1.
- K023556: Flu Oia a/B Test Kit, Thermo Biostar, Inc. (2003) Summary page 1.
- K031899: Quickvue Influenza a+B Test, Quidel Corp. (2003) Summary page 1.
- K031565: Xpect Influenza a/B, Remel, Inc. (2003) Summary page 1.
- K982429: Zstatflu Test for Influenza Types a and B Viruses, Zymetx, Inc. (1998) Summary page 2.

## Most influential descendants
- K071657: Tru Flu (2007), 0 descendants of its own

## Indications for use
ImmunoCard STAT! Flu A&B PLUS is a rapid, qualitative, lateral-flow immunoassay for detecting both influenza A and influenza B viral nucleoprotein antigens in human nasal aspirate, nasopharyngeal aspirate and nasal and nasopharyngeal swab samples. It is designed to test samples from symptomatic patients. It is recommended that all negative test results be confirmed by cell culture.

Source page: https://510kreport.com/device/K041626
Methodology: https://510kreport.com/methodology