# K021646: Binax Now Flu B Test (27 Test), Binax Now Nasopharyngeal Swab Specimen Accesory Pack

- Pathway: 510(k) (Traditional)
- Applicant: Binax, Inc.
- Decided: Sep 19, 2002 after 122 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 K991633 (1999). 1 ancestor in all.
7 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991633: Quickvue Influenza a/B Test, Quidel Corp. (1999) Summary page 1.

## Most influential descendants
- K041049: Binaxnow Influenza a & B Test (2004), 4 descendants of its own
- K053126: Binaxnow Influenza a & B Test (2005), 3 descendants of its own
- K063689: BD Directigen EZ Flu a+B Test (2007), 2 descendants of its own
- K041626: Immunocard Stat! Flu a & B (2005), 1 descendant of its own
- K101461: BD Directigen EX Flu a+B (2010), 0 descendants of its own

## Indications for use
The Binax NOW@ Flu B Test is an in vitro rapid immunochromatographic assay for the qualitative detection of influenza B nucleoprotein antigen in nasal wash and nasopharyngeal swab specimens from symptomatic patients. It is intended to aid in the rapid diagnosis of influenza B infections. Negative test results should be confirmed by cell culture.

Source page: https://510kreport.com/device/K021646
Methodology: https://510kreport.com/methodology