# K982238: Binax Now Legionella Urinary Antigen Test Model 852-020 and Binax Now Leg Ionella Urinary Antigen Control Kit Model 8522

- Pathway: 510(k) (Traditional)
- Applicant: Binax, Inc.
- Decided: Aug 21, 1998 after 57 days
- Product code: MJH (Legionella, Spp., Elisa)
- Device class: 2
- Regulation: 21 CFR 866.3300
- 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 K934965 (1994). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934965: Binax Legionella Urinary Antigen Eia, Binax, Inc. (1994) Summary page 1.

## Most influential descendants
- K070522: Modification to: Binax Now  Legionella Urinary Antigen Test, #852-000,852-012 (2007), 1 descendant of its own
- K191184: ImmuView S pneumoniae and L pneumophila Urinary Antigen Test (2020), 0 descendants of its own
- K113190: Tru Legionella (2012), 0 descendants of its own

## Recalls of this device
- Sep 29, 2006 · Not classified · Z-0222-2007: Mislabeled product: Outer kit label reads NOW Legionella Urinary Antigen Test, inside contains S. pneumonia test pouches

## Indications for use
The Binax NOW™ Legionella Urinary Antigen Test is a rapid immunochromatographic assay for the qualitative detection of Legionella pneumophila serogroup 1 antigen (L. pneumophila serogroup 1 antigen) in human urine as an adjunct to culture for the presumptive diagnosis of Legionnaires’ Disease. It is intended for in vitro diagnostic use.

Source page: https://510kreport.com/device/K982238
Methodology: https://510kreport.com/methodology