510(k) Report

510(k) · Cleared

Cleared

Gen-Probe Aptima Combo 2 Assay

K043224510(k) TraditionalCleared Aug 9, 2005260-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

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

Cleared on Aug 9, 2005 as substantially equivalent to K003395 (Gen-Probe, Inc., 2001) and 1 other predicate after a 260-day review. Its family tree reaches back 1 generation to 1996. 21 later devices descend from it.

Decided
Aug 9, 2005
Review
260 days
Class
Class II
Product code
LSL
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to P950039 (1996). 2 ancestors in all. 21 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2012: 2 descendants cleared2008: 1 descendant cleared2010: 1 descendant cleared2018: 2 descendants cleared2021: 2 descendants cleared2015: 1 descendant cleared2013: 1 descendant cleared2014: 1 descendant cleared2017: 1 descendant cleared2016: 1 descendant cleared2019: 1 descendant cleared2023: 1 descendant cleared2025: 3 descendants cleared2026: 3 descendants clearedP950039 · Thinprep (R) Processor, Model TP 2000 · Hologic, Inc. · 19961995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 6 descendants4 generations forward: 2 descendants5 generations forward: 3 descendants6 generations forward: 3 descendants P950039 · Thinprep (R) Processor, Model TP 2000 · Hologic, Inc. · 19960+5
  1. Root · 1 generation backP950039 Thinprep (R) Processor, Model TP 2000Hologic, Inc. · 1996
  2. This deviceK043224 Gen-Probe Aptima Combo 2 AssayGen-Probe, Inc. · 2005
  3. Descendant · cites it directly · 11 of its ownK092704 Abbott Realtime CT/NG and Abbott Multi-Collect Specimen Collection…Abbott Molecular, Inc. · 2010 · Recalled
  4. Descendant · 2 generations on · 10 of its ownK110923 Cobas 4800 CT / NG TestRoche Molecular Systems, Inc. · 2012 · Recalled
  5. Descendant · 3 generations on · 9 of its ownK132270 Cobas CT/NG V2.0 TestRoche Molecular Systems, Inc. · 2013
  6. Descendant · 3 generations on · 7 of its ownK163184 cobas® CT/NG v2.0 TestRoche Molecular Systems, Inc. · 2017
  7. Descendant · cites it directly · 7 of its ownK121710 Xpert CT/NGCepheid · 2012 · Recalled

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2008: 12010: 12012: 22013: 12014: 12015: 12016: 12017: 12018: 22019: 12021: 22023: 12025: 32026: 3
2008high 3 (2025) · low 0 (2009)2026

Most influential descendants

Showing 5 of 21 · See all
  • K092704Abbott Realtime CT/NG and Abbott Multi-Collect Specimen Collection Kit, Models 8L07-91…Abbott Molecular, Inc. · 2010 · cites it directly11descendants
  • K110923Cobas 4800 CT / NG TestRoche Molecular Systems, Inc. · 2012 · 2 generations on10descendants
  • K132270Cobas CT/NG V2.0 TestRoche Molecular Systems, Inc. · 2013 · 3 generations on9descendants
  • K163184cobas® CT/NG v2.0 TestRoche Molecular Systems, Inc. · 2017 · 3 generations on7descendants
  • K121710Xpert CT/NGCepheid · 2012 · cites it directly7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1P950039Thinprep (R) Processor, Model TP 2000Hologic, Inc.1996—
0 (this device)K043224Gen-Probe Aptima Combo 2 AssayGen-Probe, Inc.2005—
+1K092704Abbott Realtime CT/NG and Abbott Multi-Collect Specimen Collection Kit, Models…Abbott Molecular, Inc.20101
+2K110923Cobas 4800 CT / NG TestRoche Molecular Systems, Inc.20122
+3K132270Cobas CT/NG V2.0 TestRoche Molecular Systems, Inc.2013—
+3K163184cobas® CT/NG v2.0 TestRoche Molecular Systems, Inc.2017—
+1K121710Xpert CT/NGCepheid20123

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201010
201220
201310
201410
201510
201610
201710
201820
201910
202120
202310
202530
202630
FIG. 1 — Lineage of K043224, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K231329 Aptima Neisseria gonorrhoeae Assayscore 6.7 · 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.

TypeNumberDeviceApplicantDecidedRecalls
*K003395Gen-Probe Aptima Combo 2 Assay
Summary page 2
…Device Class 2 Regulation number 866.3390 Substantially Equivalent Devices: APTIMA Combo 2 Assay (K003395) Roche COBAS AMPLICORTM CT/NG Test (P950039/S008) Ge…
Gen-Probe, Inc.20011
*P950039Thinprep (R) Processor, Model TP 2000
Summary page 2
…APTIMA Combo 2 Assay (K003395) Roche COBAS AMPLICORTM CT/NG Test (P950039/S008) Gen-Probe Incorporated Confidential…
Hologic, Inc.1996—

Also cleared against K003395: 3 other devices →

What descends from it? (21)

See all 21

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

NumberDeviceApplicantDecidedDescendants
K092704Abbott Realtime CT/NG and Abbott Multi-Collect Specimen Collection Kit, Models 8L07-91…Abbott Molecular, Inc.201011
K121710Xpert CT/NGCepheid20127
K080739Abbott Realtime CT/NG Assay and Multi-Collect Specimen Collection KitAbbott Molecular, Inc.20080

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?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K092704 (Abbott Molecular, Inc., 2010) has gone furthest, with 11 descendants of its own.
  • 3 other devices also cite its predicate K003395.

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

2007: 22008: 12009: 32012: 22013: 22014: 32017: 12018: 32024: 1
2007high 3 (2009) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LSL

90in 2018

2009: 62 days median2014: 86 days median2018: 90 days median
2007high 90 (2018) · low 62 (2009)2026

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

Recalls per year · LSL

1in 2017

2017: 1
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

2009: 42010: 12011: 12013: 12014: 42015: 62016: 62017: 102018: 72019: 142020: 32021: 42022: 112023: 192024: 172025: 41
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
20081—00
200936204
20100—01
20110—01
20122—00
20132—01
201438604
20150—06
20160—06
20171—110
201839007
20190—014
20200—03
20210—04
20220—011
20230—019
20241—017
20250—041
20260—0—

What is it indicated for?

The APTIMA Combo 2 Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) in clinician-collected endocervical, vaginal, and male urethral swab specimens, patient-collected vaginal swab specimens*, and female and male urine specimens. The assay is also intended for use with…

Read the full statement (186 words)

The APTIMA Combo 2 Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) in clinician-collected endocervical, vaginal, and male urethral swab specimens, patient-collected vaginal swab specimens*, and female and male urine specimens. The assay is also intended for use with testing of gynecological specimens collected in the PreservCyt Solution and processed with the Cytyc ThinPrep 2000 System. The assay may be used to test specimens from symptomatic and asymptomatic individuals to aid in the diagnosis of gonococcal and/or chlamydial urogenital disease.

*Patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The vaginal swab specimen collection kit is not for home use.

The GEN-PROBE' APTIMA ® Specimen Transfer Kit is only for use with GEN-PROBE APTIMA assays for the detection of Chlamydia trachomatis and/or Neisseria gonorrhoeae. The GEN-PROBE APTIMA Specimen Transfer Kit allows for APTIMA Assay testing of gynecological specimens collected and processed by the Cytyc ThinPrep 2000 Processor according to the instructions provided.

Indications for use as stated in the FDA summary.

Also cleared against K003395

3 other devices cite the same predicate.

  • K081824BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna AssayBecton, Dickinson & CO · 2008
  • K081825BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified Dna AssayBecton, Dickinson & CO · 20081 recall
  • K032554Gen-Probe Aptima Combo 2 AssayGen-Probe, Inc. · 2003

More from Gen-Probe, Inc.

81 FDA decisions under this applicant name. See the company

  • K122062Aptima Trichomonas Vaginalis Assay - PantherGen-Probe, Inc. · 2013
  • P940034/S019Amplified MTD (Mycobacterium Tuberculosis Direct) TestGen-Probe, Inc. · 2012
  • K111409Aptima Combo 2 AssayGen-Probe, Inc. · 2012
  • P940034/S018Amplified MTD (Mycobacterium Tuberculosis Direct) TestGen-Probe, Inc. · 2010
  • P940034/S017Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test (MTD)Gen-Probe, Inc. · 2007

Recent decisions in LSL

The LSL category page

  • K231329Aptima Neisseria gonorrhoeae AssayHologic, Inc. · 2024
  • K180681Aptima Combo 2 Assay (Panther System)Hologic, Inc. · 2018
  • K173887cobas CT/NG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc. · 2018
  • K173840Xpert CT/NGCepheid · 2018
  • K163184cobas® CT/NG v2.0 TestRoche Molecular Systems, Inc. · 2017

https://510kreport.com/device/K043224 · printed Nov 5, 2026

Cite this page

510(k) Report. “K043224: Gen-Probe Aptima Combo 2 Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043224

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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