510(k) · Cleared

Cleared

BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna Assay

K081824510(k) TraditionalCleared Dec 11, 2008167-day reviewClass I21 CFR 866.3120

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

Becton, Dickinson & CO · MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia

Cleared on Dec 11, 2008 as substantially equivalent to K984631 (Becton Dickinson Microbiology Systems, 1999) and 1 other predicate after a 167-day review. Its family tree reaches back 1 generation to 1999. 9 later devices descend from it.

Decided: Dec 11, 2008
Review: 167 days
Class: Class I
Product code: MKZ
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K984631 (1999). 2 ancestors in all. 9 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK984631 Bdprobetec ET Chlamydia Trachomatis and Neisseria Gonorrhoeae…Becton Dickinson Microbiology Systems · 1999 · Recalled
This deviceK081824 BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna AssayBecton, Dickinson & CO · 2008
Descendant · cites it directly · 6 of its ownK151589 BD Max CT/GC/TV, BD Max InstrumentBecton, Dickinson and Company · 2016 · Recalled
Descendant · 2 generations on · 3 of its ownK182692 BD MAX CTGCTV2, BD MAX SystemBecton, Dickinson and Company · 2019
Descendant · 3 generations on · 1 of its ownK210585 BD CTGCTV2Becton, Dickinson and Company · 2022 · Recalled
Descendant · 2 generations on · 1 of its ownK202977 Alinity m STI AssayAbbott Molecular, Inc. · 2022
Descendant · 4 generations on · 0 of its ownK243343 BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton, · 2025

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2009high 2 (2022) · low 0 (2010)2026

Most influential descendants

Showing 5 of 9 · See all

K151589BD Max CT/GC/TV, BD Max InstrumentBecton, Dickinson and Company · 2016 · cites it directly6descendants
K182692BD MAX CTGCTV2, BD MAX SystemBecton, Dickinson and Company · 2019 · 2 generations on3descendants
K210585BD CTGCTV2Becton, Dickinson and Company · 2022 · 3 generations on1descendant
K202977Alinity m STI AssayAbbott Molecular, Inc. · 2022 · 2 generations on1descendant
K243343BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton, · 2025 · 4 generations on0descendants

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)	K081824	BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna Assay	Becton, Dickinson & CO	2008	—
+1	K151589	BD Max CT/GC/TV, BD Max Instrument	Becton, Dickinson and Company	2016	2
+2	K182692	BD MAX CTGCTV2, BD MAX System	Becton, Dickinson and Company	2019	—
+3	K210585	BD CTGCTV2	Becton, Dickinson and Company	2022	1
+2	K202977	Alinity m STI Assay	Abbott Molecular, Inc.	2022	—
+4	K243343	BD CTGCTV2	Bd Integrated Diagnostic Solutions/Becton,	2025	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2014	1	0
2016	1	0
2019	1	0
2021	1	0
2022	2	0
2023	1	0
2025	1	0

FIG. 1 — Lineage of K081824, 1999–2025Source: 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 MKZ? 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 MKZ device

#1 K230451 Aptima® Chlamydia trachomatis Assayscore 6.4 · 1 generation · no Class I recall

Get a 510(k) Report

What was it cleared against? (2)

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 …ts Regulation Number 866.3120 Product Code MKZ Predicate Devices BD ProbeTec ET CT/GC Amplified DNA Assay (K984631), APTIMA Combo 2 Assay (K003395) Device Description The BD ProbeTec CT QX Amplified DNA As…	Becton Dickinson Microbiology Systems	1999	2
*	K003395	Gen-Probe Aptima Combo 2 Assay Summary page 1 …MKZ Predicate Devices BD ProbeTec ET CT/GC Amplified DNA Assay (K984631), APTIMA Combo 2 Assay (K003395) Device Description The BD ProbeTec CT QX Amplified DNA Assay is based on the simultaneous amplification and detection of targe…	Gen-Probe, Inc.	2001	1

Also cleared against K984631: 3 other devices →

What descends from it? (9)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K151589	BD Max CT/GC/TV, BD Max Instrument	Becton, Dickinson and Company	2016	6
K140446	BD Probetec Chlamydia Trachomatis (CT) QX Amplified Dna Assay	Becton, Dickinson & CO	2014	0
K090824	BD Probetec Chlamydia Trachomatis (CT) QX Amplified Dna Assay	Becton, Dickinson & CO	2009	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?

2 of the 2 ancestors have a recall of any class.
Of its descendants, K151589 (Becton, Dickinson and Company, 2016) has gone furthest, with 6 descendants of its own.
3 other devices also cite its predicate K984631.

How does its category compare?

All MKZ devices

MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · MKZ

1in 2023

2007high 2 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MKZ

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

Recalls per year · MKZ

1in 2010

2007high 1 (2009) · low 0 (2007)2026

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

Adverse event reports per year · MKZ

1in 2025

2007high 9 (2011) · low 0 (2007)2025

MAUDE reports naming product code MKZ, 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	2	—	0	0
2009	2	—	1	0
2010	0	—	1	1
2011	0	—	0	9
2012	1	—	0	1
2013	0	—	0	6
2014	1	—	0	2
2015	0	—	0	1
2016	0	—	0	1
2017	0	—	0	6
2018	0	—	0	3
2019	0	—	0	3
2020	0	—	0	7
2021	0	—	0	9
2022	0	—	0	2
2023	1	—	0	4
2024	0	—	0	7
2025	0	—	0	1
2026	0	—	0	—

What is it indicated for?

The BD ProbeTec Chlamydia trachomatis (CT) QX Amplified DNA Assay, when tested with the BD ViperTM System in Extracted Mode, uses Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Chlamydia trachomatis DNA in clinician-collected female endocervical and male urethral swabs, patient-collected vaginal swab specimens (in a clinical setting), and female and male urine specimens. The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial urogenital disease.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081824 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081824: BD Probetec Chlamydia Trachomatis (CT) Q 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/K081824

Report an extraction error

Are you the manufacturer?

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