# K113190: Tru Legionella

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Bioscience, Inc.
- Decided: Feb 24, 2012 after 116 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.
No later device cites it as a predicate yet.
0 of 3 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.

## Indications for use
The TRU Legionella assay is an in vitro, rapid, lateral-flow immunoassay for the qualitative detection of Legionella pneumophila serogroup I antigens in human urine specimens. It is designed to test specimens from patients with symptoms of pneumonia. Test results are to be used as an aid in diagnosis of Legionella pneumophila serogroup I infection. A negative result does not preclude infection with Legionellapneumophild serogroup 1. Test results are to be used in conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures.

Source page: https://510kreport.com/device/K113190
Methodology: https://510kreport.com/methodology