510(k) · Cleared

Cleared

BD Probe Tec Urine Preservative Transport

K052224510(k) SpecialCleared Sep 12, 200527-day reviewClass II21 CFR 866.3390

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

Becton, Dickinson & CO · LSL Dna-Reagents, Neisseria

Cleared on Sep 12, 2005 as substantially equivalent to K984631 (Becton Dickinson Microbiology Systems, 1999) after a 27-day review. Its family tree reaches back 1 generation to 1999. 1 later device descends from it.

Decided: Sep 12, 2005
Review: 27 days
Class: Class II
Product code: LSL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K984631 (1999). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK984631 Bdprobetec ET Chlamydia Trachomatis and Neisseria Gonorrhoeae…Becton Dickinson Microbiology Systems · 1999 · Recalled
This deviceK052224 BD Probe Tec Urine Preservative TransportBecton, Dickinson & CO · 2005
Descendant · cites it directly · 0 of its ownK080739 Abbott Realtime CT/NG Assay and Multi-Collect Specimen Collection KitAbbott Molecular, Inc. · 2008

Most influential descendants

Showing 1 of 1 · See all

K080739Abbott Realtime CT/NG Assay and Multi-Collect Specimen Collection KitAbbott Molecular, Inc. · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K984631	Bdprobetec ET Chlamydia Trachomatis and Neisseria Gonorrhoeae Amplified Dna…	Becton Dickinson Microbiology Systems	1999	2
0 (this device)	K052224	BD Probe Tec Urine Preservative Transport	Becton, Dickinson & CO	2005	—
+1	K080739	Abbott Realtime CT/NG Assay and Multi-Collect Specimen Collection Kit	Abbott Molecular, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

FIG. 1 — Lineage of K052224, 1999–2008Source: FDA 510(k) summaries, read by 510(k) Report · 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.

Planning a device in LSL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LSL device

#1 K231329 Aptima Neisseria gonorrhoeae Assayscore 6.7 · 1 generation · no Class I recall

Get a 510(k) Report

What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K984631	Bdprobetec ET Chlamydia Trachomatis and Neisseria Gonorrhoeae Amplified Dna Assay Summary page 1 …Neisseria gonorrhoeae(OC) ProbeTec ET Chlamydia trachomatis(CT) and Amplified DNA Assays (K98463 1) INTENDED USE: gonorrohoeaeAmplified DNA The BD ProbeTecm ET Ch…	Becton Dickinson Microbiology Systems	1999	2

Also cleared against K984631: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K080739	Abbott Realtime CT/NG Assay and Multi-Collect Specimen Collection Kit	Abbott Molecular, Inc.	2008	0

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.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K080739 (Abbott Molecular, Inc., 2008) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K984631.

How does its category compare?

All LSL devices

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

FDA decisions per year · LSL

1in 2024

2007high 3 (2009) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LSL

90in 2018

2007high 90 (2018) · low 62 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LSL

1in 2017

2007high 1 (2017) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LSL

41in 2025

2007high 41 (2025) · low 0 (2007)2025

MAUDE reports naming product code LSL, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	0
2008	1	—	0	0
2009	3	62	0	4
2010	0	—	0	1
2011	0	—	0	1
2012	2	—	0	0
2013	2	—	0	1
2014	3	86	0	4
2015	0	—	0	6
2016	0	—	0	6
2017	1	—	1	10
2018	3	90	0	7
2019	0	—	0	14
2020	0	—	0	3
2021	0	—	0	4
2022	0	—	0	11
2023	0	—	0	19
2024	1	—	0	17
2025	0	—	0	41
2026	0	—	0	—

What is it indicated for?

Read the full statement (126 words)

The BD ProbeTec ET Chlamydia trachomatis and Neisseria gonorrohoeae Amplified DNA Assays, when tested with the BD ProbeTec ET System, uses Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical swabs, male urethral swabs, and in female and male urine specimens as evidence of infection with C. trachomatis and N. gonorroheae, or of co-infection with both C. trachomatis and N. gonorroheae. Specimens may be from symptomatic and asymptomatic females and males. A separate Amplification Control is an option for inhibition testing (BD ProbeTec ET CT/GC/AC Reagent Pack). The BD ProbeTec ET CT/GC assays may be performed using either the BD ProbeTec ET System or a combination of the BD ProbeTec ET System and BD Viper instrument.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052224 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052224: BD Probe Tec Urine Preservative Transport.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052224

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Record history

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