# K991074: Bartels Legionella Urinary Antigen Elisa Test

- Pathway: 510(k) (Traditional)
- Applicant: Intracel Corp.
- Decided: Dec 21, 1999 after 265 days
- Product code: MJH (Legionella, Spp., Elisa)
- Device class: 2
- Regulation: 21 CFR 866.3300
- Recalls of this device: 2 (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. The FDA summary names its predicate without a number.
- (no number) Binax Legionella Urinary Antigen EIA: named in the summary without a submission number

## Recalls of this device
- Jul 22, 2025 · Class II · Z-2292-2025: Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.
- Oct 11, 2021 · Class II · Z-0382-2022: Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay

## Indications for use
Bartels Legionella Urinary Antigen ELISA Test is intended as an adjunct to culture for the presumptive diagnosis of past or current Legionnaires' Disease by qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine.

Source page: https://510kreport.com/device/K991074
Methodology: https://510kreport.com/methodology