510(k) · Cleared

Recalled · Class III · 2014

Gen-Probe Aptima Combo 2 Assay

K003395510(k) TraditionalCleared May 21, 2001201-day reviewClass II21 CFR 866.3390Recalls 1

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

Gen-Probe, Inc. · LSL Dna-Reagents, Neisseria

Cleared on May 21, 2001 after a 201-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 42 later devices descend from it. It has been recalled once.

Decided: May 21, 2001
Review: 201 days
Class: Class II
Product code: LSL
Recalls: 1
Predicates: 0

42 later devices descend from it, 4 citing it directly.

This deviceK003395 Gen-Probe Aptima Combo 2 AssayGen-Probe, Inc. · 2001
Descendant · cites it directly · 26 of its ownK081825 BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified Dna AssayBecton, Dickinson & CO · 2008 · Recalled
Descendant · cites it directly · 21 of its ownK043224 Gen-Probe Aptima Combo 2 AssayGen-Probe, Inc. · 2005
Descendant · 2 generations on · 13 of its ownK091724 BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna AssayBecton, Dickinson & CO · 2009
Descendant · 2 generations on · 13 of its ownK091730 BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna AssayBecton, Dickinson & CO · 2009 · Recalled
Descendant · 2 generations on · 11 of its ownK092704 Abbott Realtime CT/NG and Abbott Multi-Collect Specimen Collection…Abbott Molecular, Inc. · 2010 · Recalled

Showing 5 of 42 descendants. See all descendants

Descendants cleared per year

2003high 5 (2009) · low 0 (2004)2026

Most influential descendants

Showing 5 of 42 · See all

K081825BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified Dna AssayBecton, Dickinson & CO · 2008 · cites it directly26descendants
K043224Gen-Probe Aptima Combo 2 AssayGen-Probe, Inc. · 2005 · cites it directly21descendants
K091724BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna AssayBecton, Dickinson & CO · 2009 · 2 generations on13descendants
K091730BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna AssayBecton, Dickinson & CO · 2009 · 2 generations on13descendants
K092704Abbott Realtime CT/NG and Abbott Multi-Collect Specimen Collection Kit, Models 8L07-91…Abbott Molecular, Inc. · 2010 · 2 generations on11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003395	Gen-Probe Aptima Combo 2 Assay	Gen-Probe, Inc.	2001	—
+1	K081825	BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified Dna Assay	Becton, Dickinson & CO	2008	1
+1	K043224	Gen-Probe Aptima Combo 2 Assay	Gen-Probe, Inc.	2005	—
+2	K091724	BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna Assay	Becton, Dickinson & CO	2009	—
+2	K091730	BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna Assay	Becton, Dickinson & CO	2009	1
+2	K092704	Abbott Realtime CT/NG and Abbott Multi-Collect Specimen Collection Kit, Models…	Abbott Molecular, Inc.	2010	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	1	0
2008	3	0
2009	5	0
2010	1	0
2012	2	0
2013	1	0
2014	4	0
2015	1	0
2016	2	0
2017	1	0
2018	2	0
2019	3	0
2020	1	0
2021	3	0
2022	2	0
2023	2	0
2025	4	0
2026	3	0

FIG. 1 — Lineage of K003395, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (42)

See all 42

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

Number	Device	Applicant	Decided	Descendants
K081825	BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified Dna Assay	Becton, Dickinson & CO	2008	26
K043224	Gen-Probe Aptima Combo 2 Assay	Gen-Probe, Inc.	2005	21
K081824	BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna Assay	Becton, Dickinson & CO	2008	9
K032554	Gen-Probe Aptima Combo 2 Assay	Gen-Probe, Inc.	2003	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 17, 2014	Class III	Z-1793-2014	Labeling mix-ups	Incorrect labeling was used on each pouch of the affected lots of APTIMA Urine Specimen Collection Kits. The outer box of the kits are identified correctly as "APTIMA Urine Collection Kits"; however, the inner pouches are incorrectly…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K081825 (Becton, Dickinson & CO, 2008) has gone furthest, with 26 descendants of its own.

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	—

https://510kreport.com/device/K003395 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003395: Gen-Probe Aptima Combo 2 Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003395

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026