# K052224: BD Probe Tec Urine Preservative Transport

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson & CO
- Decided: Sep 12, 2005 after 27 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
Longest line of descent: 1 generation back to K984631 (1999). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984631: Bdprobetec ET Chlamydia Trachomatis and Neisseria Gonorrhoeae Amplified Dna Assay, Becton Dickinson Microbiology Systems (1999) Summary page 1.

## Most influential descendants
- K080739: Abbott Realtime CT/NG Assay and Multi-Collect Specimen Collection Kit (2008), 0 descendants of its own

## Indications for use
The BD ProbeTec ET Chlamydia trachomatis and Neisseria gonorrohoeae Amplified DNA Assays, when tested with the BD ProbeTec ET System, uses 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 and N. gonorroheae, or of co-infection with both C. trachomatis and N. gonorroheae. Specimens may be from symptomatic and asymptomatic females and males. A separate Amplification Control is an option for inhibition testing (BD ProbeTec ET CT/GC/AC Reagent Pack). The BD ProbeTec ET CT/GC assays may be performed using either the BD ProbeTec ET System or a combination of the BD ProbeTec ET System and BD Viper instrument.

Source page: https://510kreport.com/device/K052224
Methodology: https://510kreport.com/methodology