# K012521: Binax Now Streptococcus Pneumoniae Test

- Pathway: 510(k) (Traditional)
- Applicant: Binax, Inc.
- Decided: Nov 30, 2001 after 116 days
- Product code: GTZ (Antisera, All Groups, Streptococcus Spp.)
- Device class: 1
- Regulation: 21 CFR 866.3740
- Recalls of this device: 1 (0 Class I)
- 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

## Recalls of this device
- Aug 20, 2024 · Class II · Z-3184-2024: Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.

## Indications for use
The Binax NOW® Streptococcus pneumoniae Test is an in vitro rapid immunochromatographic (ICT) assay for the detection of Streptococcus pneumoniae (S. pneumoniae) antigen in the urine of patients with pneumonia and in the cerebral spinal fluid (CSF) of patients with meningitis. Tt is intended, in conjunction with culture and other methods, to aid in the presumptive diagnosis of both pneumococcal pneumonia and pneumococcal meningitis.

Source page: https://510kreport.com/device/K012521
Methodology: https://510kreport.com/methodology