# K991726: Binax Nowr Streptococcus Pneumoniae Urinary Antigen Test (22 Test Kit),(12 Test Kit), Binax Nowr Streptococcus Pneumoni

- Pathway: 510(k) (Traditional)
- Applicant: Binax, Inc.
- Decided: Aug 27, 1999 after 99 days
- Product code: GTZ (Antisera, All Groups, Streptococcus Spp.)
- Device class: 1
- Regulation: 21 CFR 866.3740
- 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 K854852 (1986). 1 ancestor in all.
1 later device descends 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)
- K854852: Wellcogen Bacterial Antigen Kit, Wellcome Diagnostics (1986) Summary page 1.

## Most influential descendants
- K191184: ImmuView S pneumoniae and L pneumophila Urinary Antigen Test (2020), 0 descendants of its own

## Indications for use
The Binax Now® Streptococcus pneumoniae Urinary Antigen Test is a rapid immunochromatographic assay for the detection of Streptococcus pneumoniae in human urine as an adjunct to culture for the presumptive diagnosis of pneumococcal pneumonia. It is intended for in vitro diagnostic use.

Source page: https://510kreport.com/device/K991726
Methodology: https://510kreport.com/methodology