510(k) · Cleared

Cleared

BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna Assay

K140448510(k) TraditionalCleared May 20, 201488-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 May 20, 2014 as substantially equivalent to K081825 (Becton, Dickinson & CO, 2008) after an 88-day review. Its family tree reaches back 2 generations to 2001.

Decided: May 20, 2014
Review: 88 days
Class: Class II
Product code: LSL
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K003395 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK003395 Gen-Probe Aptima Combo 2 AssayGen-Probe, Inc. · 2001 · Recalled
1 generation backK081825 BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified Dna AssayBecton, Dickinson & CO · 2008 · Recalled
This deviceK140448 BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna AssayBecton, Dickinson & CO · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K003395	Gen-Probe Aptima Combo 2 Assay	Gen-Probe, Inc.	2001	1
−1	K081825	BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified Dna Assay	Becton, Dickinson & CO	2008	1
0 (this device)	K140448	BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna Assay	Becton, Dickinson & CO	2014	—

FIG. 1 — Lineage of K140448, 2001–2014Source: 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

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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
*	K081825	BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified Dna Assay Summary page 1 …ice The RD ProbeTec Neisseriagonorrhoeae (CC) Q" Amplified DNA Assay (BD ProbeTec GCQ Assay) was cleared for use with the predicate RD Viper System in extracted mode via K08 1825. Device Description The BD ProbeTec GCQ Assay is based on the simultaneous amplification and detection of target DNA using ampl…	Becton, Dickinson & CO	2008	1

Also cleared against K081825: 6 other devices →

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.

What does this lineage say?

The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 7.6 years on median.
2 of the 2 ancestors have a recall of any class.
6 other devices also cite its predicate K081825.

How does its category compare?

All LSL devices

LSL Dna-Reagents, Neisseria: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

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 (125 words)

The BD ProbeTec Neisseria gonorrhoeae (GC) QX Amplified DNA Assay, when tested with either the BD Viper System in Extracted Mode or the BD Viper LT System, uses Strand Displacement Amplification technology for the direct, qualitative detection of Neisseria gonorrhoeae DNA in clinician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens (both UPT and Neat). The assay is also intended for use with gynecological specimens collected in BD SurePath Preservative Fluid or PreservCyt Solution using an aliquot that is removed prior to processing for either the BD SurePath or ThinPrep Pap test. The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of gonococcal urogenital disease.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K140448 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140448: BD Probetec Neisseria Gonorrhoeae (GC) QX 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/K140448

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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