# K984631: Bdprobetec ET Chlamydia Trachomatis and Neisseria Gonorrhoeae Amplified Dna Assay

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Microbiology Systems
- Decided: Nov 4, 1999 after 309 days
- Product code: LSL (Dna-Reagents, Neisseria)
- Device class: 2
- Regulation: 21 CFR 866.3390
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 4 cite it directly.
0 of 15 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) Chlamydia cell culture: named in the summary without a submission number
- (no number) Neisseria gonorrhoeae culture: named in the summary without a submission number
- (no number) Abbott LCx® Chlamydia trachomatis Assay: 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
- K081824: BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna Assay (2008), 9 descendants of its own
- K151589: BD Max CT/GC/TV, BD Max Instrument (2016), 6 descendants of its own
- K182692: BD MAX CTGCTV2, BD MAX System (2019), 3 descendants of its own
- K210585: BD CTGCTV2 (2022), 1 descendant of its own
- K202977: Alinity m STI Assay (2022), 1 descendant of its own

## Recalls of this device
- Sep 29, 2010 · Not classified · Z-2658-2011: 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: Component of in vitro diagnostic device was incorrectly installed causing incorrect reporting of patient results.

## Indications for use
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).

Source page: https://510kreport.com/device/K984631
Methodology: https://510kreport.com/methodology