# K970149: Legionella Elisa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Jun 18, 1997 after 154 days
- Product code: LHL (Reagents, Antibody, Legionella, Direct & Indirect Fluorescent)
- 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
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Dec 23, 2004 · Not classified · Z-0541-05: The kits belonging to lot #s 30804/30804Z and 91803Z may lose activity, after one or two usages, causing the OD values for the Cut-Off Calibrator and/or Positive Control to be recovered below their sp

## Indications for use
The Zeus Scientific, Inc. Legionella ELISA test system is intended for the quantitative and/or quantitative detection of IgG/A/M-class antibody to Legionella pneumophila Groups 1 - 6 in human serum. The test system is intended to be used as an aid in the diagnosis of Legionella-related infections. This test is for in vitro diagnostic use.

Source page: https://510kreport.com/device/K970149
Methodology: https://510kreport.com/methodology