510(k) · Cleared
Recalled · 2010Abbott Realtime CT/NG and Abbott Multi-Collect Specimen Collection Kit, Models 8L07-91, 9K12-03
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Molecular, Inc. · LSK Dna-Reagents, Chlamydia
Cleared on May 28, 2010 as substantially equivalent to K043224 (Gen-Probe, Inc., 2005) and 1 other predicate after a 267-day review. Its family tree reaches back 2 generations to 1996. 11 later devices descend from it. It has been recalled once.
- Decided
- May 28, 2010
- Review
- 267 days
- Class
- Class I
- Product code
- LSK
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to P950039 (1996). 4 ancestors in all. 11 later devices descend from it, 1 citing it directly.
- Root · 2 generations backP950039 Thinprep (R) Processor, Model TP 2000Hologic, Inc. · 1996
- 1 generation backK043224 Gen-Probe Aptima Combo 2 AssayGen-Probe, Inc. · 2005
- This deviceK092704 Abbott Realtime CT/NG and Abbott Multi-Collect Specimen Collection…Abbott Molecular, Inc. · 2010
- Descendant · cites it directly · 10 of its ownK110923 Cobas 4800 CT / NG TestRoche Molecular Systems, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 9 of its ownK132270 Cobas CT/NG V2.0 TestRoche Molecular Systems, Inc. · 2013
- Descendant · 2 generations on · 7 of its ownK163184 cobas® CT/NG v2.0 TestRoche Molecular Systems, Inc. · 2017
- Descendant · 3 generations on · 6 of its ownK173887 cobas CT/NG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc. · 2018
- Descendant · 4 generations on · 3 of its ownK202408 cobas CTNG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc. · 2021
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K110923Cobas 4800 CT / NG TestRoche Molecular Systems, Inc. · 2012 · cites it directly10descendants
- K132270Cobas CT/NG V2.0 TestRoche Molecular Systems, Inc. · 2013 · 2 generations on9descendants
- K163184cobas® CT/NG v2.0 TestRoche Molecular Systems, Inc. · 2017 · 2 generations on7descendants
- K173887cobas CT/NG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc. · 2018 · 3 generations on6descendants
- K202408cobas CTNG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc. · 2021 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P950039 | Thinprep (R) Processor, Model TP 2000 | Hologic, Inc. | 1996 | — |
| −1 | K043224 | Gen-Probe Aptima Combo 2 Assay | Gen-Probe, Inc. | 2005 | — |
| 0 (this device) | K092704 | Abbott Realtime CT/NG and Abbott Multi-Collect Specimen Collection Kit, Models… | Abbott Molecular, Inc. | 2010 | — |
| +1 | K110923 | Cobas 4800 CT / NG Test | Roche Molecular Systems, Inc. | 2012 | 2 |
| +2 | K132270 | Cobas CT/NG V2.0 Test | Roche Molecular Systems, Inc. | 2013 | — |
| +2 | K163184 | cobas® CT/NG v2.0 Test | Roche Molecular Systems, Inc. | 2017 | — |
| +3 | K173887 | cobas CT/NG for use on cobas 6800/8800 systems | Roche Molecular Systems, Inc. | 2018 | — |
| +4 | K202408 | cobas CTNG for use on cobas 6800/8800 systems | Roche Molecular Systems, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 0 |
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 LSK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the 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 | Decided |
|---|---|---|---|
| * | K043224 | Gen-Probe Aptima Combo 2 AssaySummary page 4…Substantially Equivalent Devices Abbott RealTime CT/NG (List No. 8L07-91) Predicate Devices: GEN-PROBE APTIMA Combo 2 Assay (Assigned 510(k) No. K043224), Becton Dickenson ProbeTec ET Chlamydia trachomatis /Neisseria gonorrhoeae Amplified DNA Assay (Assigned 510(k) No.… | 2005 |
| * | K012351 | Bdprobetec ET CT/GC Amplified Dna AssaySummary page 4…bo 2 Assay (Assigned 510(k) No. K043224), Becton Dickenson ProbeTec ET Chlamydia trachomatis /Neisseria gonorrhoeae Amplified DNA Assay (Assigned 510(k) No. K01235 1). The Abbott RealTime CT/NO assay was also compared to cell culture methods intended for the qualitative detection of Neisseria… | 2001 |
| † | K940162 | Gonochek II Reagent Tubes | 1994 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110923 | Cobas 4800 CT / NG Test | 2012 | 10 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 20, 2010 | Not classified | Z-1397-2011 | Other | Internal testing identified the potential of under filled and over filled enzyme reagent vials which may result in obtaining less than the total number of tests per kit as described on the package insert. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K110923 (Roche Molecular Systems, Inc., 2012) has gone furthest, with 10 descendants of its own.
- 2 other devices also cite its predicate K043224.
How does its category compare?
All LSK devicesLSK Dna-Reagents, Chlamydia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · LSK
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · LSK
Too few LSK 510(k)s in any year since 2007 to give a median.
Recalls per year · LSK
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LSK
No MAUDE report names LSK since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 1 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Abbott RealTimne CT/NO (List No. 8L07-9l1) assay is anl in vitro polyrnerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA of Chlamydia trachomatis and thle genomic DNA of Neisseria gonorrhoeae. The assay may be used to test thle following specimens from symptomatic individuals: female endocervical swab, clinician-collected vaginal swab, and patient-collected vaginal swab specimens; male urethral swab specimens; and female and male urine specimens. The assay may be used to test the following specirriens from asymptornatic individuals: clinician-collected vagina! swab and patient-collected vaginal swab specimens; female and male~urine specimens.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K092704 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092704: Abbott Realtime CT/NG and Abbott Multi-Collect Specimen Collection Kit, Models 8L07-91, 9K12-03.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092704
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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