# K033861: BD Probetec ET Legionella Pneumophila (LP) Amplified Dna Assay

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Mar 9, 2004 after 88 days
- Product code: LQH (Dna-Reagents, Legionella)
- 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) Bacterial culture methods: named in the summary without a submission number
- (no number) Bartels Legionella Urinary Antigen ELISA Test: named in the summary without a submission number
- (no number) Binax NOW Legionella Urinary Antigen Tests: named in the summary without a submission number
- (no number) Medical Diagnostic Technologies' Polyvalent Fluorescent Antibody Reagents for Legionella: named in the summary without a submission number
- (no number) Gen-Probe Legionella Rapid Diagnostic System: named in the summary without a submission number
- (no number) BD ProbeTec ET assays for Mycobacterium tuberculosis Complex (ctb) Culture Identification and Chlamydia trachomatis/Neisseria gonorrhoeae (CT/GC): named in the summary without a submission number

## Indications for use
The BD 'ProbeTeCTM ET Legionellapneumophila (LP) Amplified DNA Assay, for use with the BD ProbeTec ET System, employs Strand Displacement Amplification (SDA) technology for the direct qualitative detection of Legionellapneumophila DNA (serogroups 1-14) in sputum specimens from patients with a clinical suspicion of pneumonia. It is intended to aid in the presumptive diagnosis of Legionnaires' disease in conjunction with culture and other methods.

Source page: https://510kreport.com/device/K033861
Methodology: https://510kreport.com/methodology