# K012351: Bdprobetec ET CT/GC Amplified Dna Assay

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Sep 18, 2001 after 55 days
- Product code: LSL (Dna-Reagents, Neisseria)
- Device class: 2
- Regulation: 21 CFR 866.3390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
21 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Neisseria gonorrhoeae culture: named in the summary without a submission number
- (no number) Abbott LCx® Neisseria gonorrhoeae Assay: named in the summary without a submission number

## Most influential descendants
- K092704: Abbott Realtime CT/NG and Abbott Multi-Collect Specimen Collection Kit, Models 8L07-91, 9K12-03 (2010), 11 descendants of its own
- K110923: Cobas 4800 CT / NG Test (2012), 10 descendants of its own
- K132270: Cobas CT/NG V2.0 Test (2013), 9 descendants of its own
- K163184: cobas® CT/NG v2.0 Test (2017), 7 descendants of its own
- K121710: Xpert CT/NG (2012), 7 descendants of its own

## Indications for use
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).

Source page: https://510kreport.com/device/K012351
Methodology: https://510kreport.com/methodology