510(k) · Cleared
ClearedBdprobetec ET CT/GC Amplified Dna Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson & CO · LSL Dna-Reagents, Neisseria
Cleared on Sep 18, 2001 after a 55-day review. The FDA summary names its predicate without a number. 21 later devices descend from it.
- Decided
- Sep 18, 2001
- Review
- 55 days
- Class
- Class II
- Product code
- LSL
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 3 citing it directly.
- This deviceK012351 Bdprobetec ET CT/GC Amplified Dna AssayBecton, Dickinson & CO · 2001
- Descendant · cites it directly · 11 of its ownK092704 Abbott Realtime CT/NG and Abbott Multi-Collect Specimen Collection…Abbott Molecular, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 10 of its ownK110923 Cobas 4800 CT / NG TestRoche Molecular Systems, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 9 of its ownK132270 Cobas CT/NG V2.0 TestRoche Molecular Systems, Inc. · 2013
- Descendant · 3 generations on · 7 of its ownK163184 cobas® CT/NG v2.0 TestRoche Molecular Systems, Inc. · 2017
- 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
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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012351 | Bdprobetec ET CT/GC Amplified Dna Assay | Becton, Dickinson & CO | 2001 | — |
| +1 | K092704 | Abbott Realtime CT/NG and Abbott Multi-Collect Specimen Collection Kit, Models… | Abbott Molecular, Inc. | 2010 | 1 |
| +2 | K110923 | Cobas 4800 CT / NG Test | Roche Molecular Systems, Inc. | 2012 | 2 |
| +3 | K132270 | Cobas CT/NG V2.0 Test | Roche Molecular Systems, Inc. | 2013 | — |
| +3 | K163184 | cobas® CT/NG v2.0 Test | Roche Molecular Systems, Inc. | 2017 | — |
| +1 | K121710 | Xpert CT/NG | Cepheid | 2012 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 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 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
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 |
|---|---|---|---|
| * | — | Neisseria gonorrhoeae culture Named without a submission number | |
| * | — | Abbott LCx® Neisseria gonorrhoeae Assay Named without a submission number |
What descends from it? (21)
See all 213 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K092704 (Abbott Molecular, Inc., 2010) has gone furthest, with 11 descendants of its own.
How does its category compare?
All LSL devicesLSL Dna-Reagents, Neisseria: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LSL
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LSL
90in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LSL
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LSL
41in 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?
The BDProbeTec™ ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays, when tested with the BDProbeTec™ ET System, use Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical swabs, male urethral swabs, and in female and male urine specimens as evidence of infection with C. trachomatis, N. gonorrhoeae, or of co-infection with both C. trachomatis and N. gonorrhoeae. Specimens may be from symptomatic or asymptomatic females and males. A separate Amplification Control is an option for inhibition testing (BDProbeTec™ ET CT/GC/AC Reagent Pack).
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/K012351 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012351: Bdprobetec ET CT/GC 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/K012351
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026