510(k) · Cleared
Recalled · 2010Bdprobetec ET Chlamydia Trachomatis and Neisseria Gonorrhoeae Amplified Dna Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton Dickinson Microbiology Systems · LSL Dna-Reagents, Neisseria
Cleared on Nov 4, 1999 after a 309-day review. The FDA summary names its predicate without a number. 14 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 4, 1999
- Review
- 309 days
- Class
- Class II
- Product code
- LSL
- Recalls
- 2
- Predicates
- 0
14 later devices descend from it, 4 citing it directly.
- This deviceK984631 Bdprobetec ET Chlamydia Trachomatis and Neisseria Gonorrhoeae…Becton Dickinson Microbiology Systems · 1999
- Descendant · cites it directly · 9 of its ownK081824 BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna AssayBecton, Dickinson & CO · 2008
- Descendant · 2 generations on · 6 of its ownK151589 BD Max CT/GC/TV, BD Max InstrumentBecton, Dickinson and Company · 2016 · Recalled
- Descendant · 3 generations on · 3 of its ownK182692 BD MAX CTGCTV2, BD MAX SystemBecton, Dickinson and Company · 2019
- Descendant · 4 generations on · 1 of its ownK210585 BD CTGCTV2Becton, Dickinson and Company · 2022 · Recalled
- Descendant · 3 generations on · 1 of its ownK202977 Alinity m STI AssayAbbott Molecular, Inc. · 2022
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K081824BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna AssayBecton, Dickinson & CO · 2008 · cites it directly9descendants
- K151589BD Max CT/GC/TV, BD Max InstrumentBecton, Dickinson and Company · 2016 · 2 generations on6descendants
- K182692BD MAX CTGCTV2, BD MAX SystemBecton, Dickinson and Company · 2019 · 3 generations on3descendants
- K210585BD CTGCTV2Becton, Dickinson and Company · 2022 · 4 generations on1descendant
- K202977Alinity m STI AssayAbbott Molecular, Inc. · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984631 | Bdprobetec ET Chlamydia Trachomatis and Neisseria Gonorrhoeae Amplified Dna… | Becton Dickinson Microbiology Systems | 1999 | — |
| +1 | K081824 | BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna Assay | Becton, Dickinson & CO | 2008 | — |
| +2 | K151589 | BD Max CT/GC/TV, BD Max Instrument | Becton, Dickinson and Company | 2016 | 2 |
| +3 | K182692 | BD MAX CTGCTV2, BD MAX System | Becton, Dickinson and Company | 2019 | — |
| +4 | K210585 | BD CTGCTV2 | Becton, Dickinson and Company | 2022 | 1 |
| +3 | K202977 | Alinity m STI Assay | Abbott Molecular, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | — | Chlamydia cell culture Named without a submission number | |
| * | — | Neisseria gonorrhoeae culture Named without a submission number | |
| * | — | Abbott LCx® Chlamydia trachomatis Assay Named without a submission number | |
| * | — | Abbott LCx® Neisseria gonorrhoeae Assay Named without a submission number |
What descends from it? (14)
See all 144 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 29, 2010 | Not classified | Z-2658-2011 | Process control | In vitro diagnostic reagent packs may be underfilled and contribute to invalid quality control testing or false positive patient results. |
| Jul 21, 2003 | Not classified | Z-1094-03 | Other | Component of in vitro diagnostic device was incorrectly installed causing incorrect reporting of patient results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K081824 (Becton, Dickinson & CO, 2008) has gone furthest, with 9 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 (CT) and Neisseria gonorrhoeae (GC) 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…
Read the full statement (122 words)
The BDProbeTec™ ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) 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 for the BDProbeTec ET CT and GC Assays, from symptomatic or asymptomatic males for the BDProbeTec ET CT Assay, and from symptomatic males for the BDProbeTec ET GC Assay. 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/K984631 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984631: Bdprobetec ET Chlamydia Trachomatis and Neisseria Gonorrhoeae 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/K984631
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