510(k) · Cleared

Cleared

BD Probetec ET Legionella Pneumophila (LP) Amplified Dna Assay

K033861510(k) TraditionalCleared Mar 9, 200488-day reviewClass II21 CFR 866.3300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Becton, Dickinson & CO · LQH Dna-Reagents, Legionella

Cleared on Mar 9, 2004 after an 88-day review. The FDA summary names its predicate without a number.

Decided: Mar 9, 2004
Review: 88 days
Class: Class II
Product code: LQH
Recalls: None
Predicates: 0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K033861Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (6)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Recalls
*	—	Bacterial culture methods Named without a submission number	—
*	—	Bartels Legionella Urinary Antigen ELISA Test Named without a submission number	—
*	—	Binax NOW Legionella Urinary Antigen Tests Named without a submission number	—
*	—	Medical Diagnostic Technologies' Polyvalent Fluorescent Antibody Reagents for Legionella Named without a submission number	—
*	—	Gen-Probe Legionella Rapid Diagnostic System Named without a submission number	—
*	—	BD ProbeTec ET assays for Mycobacterium tuberculosis Complex (ctb) Culture… Named without a submission number	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All LQH devices

LQH Dna-Reagents, Legionella: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LQH

FDA has decided no LQH device since 2007.

Median 510(k) review, days · LQH

Too few LQH 510(k)s in any year since 2007 to give a median.

Recalls per year · LQH

No recall names LQH since 2007.

Adverse event reports per year · LQH

No MAUDE report names LQH since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033861 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033861: BD Probetec ET Legionella Pneumophila (LP) Amplified Dna Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033861

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026