# K963318: Legionella Igg/Igm Elisa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Armkel, LLC
- Decided: Mar 3, 1997 after 192 days
- Product code: LHL (Reagents, Antibody, Legionella, Direct & Indirect Fluorescent)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BioWhittaker’s Legionella STAT test: named in the summary without a submission number

## Indications for use
The Legionella pneumophila IgG/IgM ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection of total antibodies (IgG and IgM) to Legionella pneumophila serogroups 1-6 in serum from patients with clinical suspicion of Legionella Disease.

Source page: https://510kreport.com/device/K963318
Methodology: https://510kreport.com/methodology