# K070522: Modification to: Binax Now  Legionella Urinary Antigen Test, #852-000,852-012

- Pathway: 510(k) (Special)
- Applicant: Inverness Medical Professional Diagnostics
- Decided: Mar 15, 2007 after 20 days
- Product code: MJH (Legionella, Spp., Elisa)
- Device class: 2
- Regulation: 21 CFR 866.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K934965 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982238: Binax Now Legionella Urinary Antigen Test Model 852-020 and Binax Now Leg Ionella Urinary Antigen Control Kit Model 8522, Binax, Inc. (1998) 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® Legionella Urinary Antigen Test is an in vitro rapid immunochromatographic assay for the qualitative detection of Legionella pneumophila serogroup 1 antigen (L. pneumophila serogroup 1 antigen) in urine specimens from patients with symptoms of pneumonia. It is intended to aid in the presumptive diagnosis of Legionella infection (Legionnaires' disease) caused by L. pneumophila serogroup 1 in conjunction with culture and other methods.

Source page: https://510kreport.com/device/K070522
Methodology: https://510kreport.com/methodology