# K052481: BD Viper System

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson & CO
- Decided: Nov 28, 2005 after 80 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: 2 generations back to K940390 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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.
- K023955: BD Viper Instrument, Becton, Dickinson & CO (2003) Summary page 1.

## Indications for use
The BD ProbeTec ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) Amplified DNA Assays, when tested with the BD ProbeTec 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 (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. The BD Viper System, when used with BD ProbeTec ET amplified nucleic acid assays, is intended for the in vitro detection of targeted organisms from specimens as identified in the assay-specific reagent package insert(s).

Source page: https://510kreport.com/device/K052481
Methodology: https://510kreport.com/methodology