# K023955: BD Viper Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Jun 24, 2003 after 209 days
- Product code: JQW (Station, Pipetting And Diluting, For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2750
- 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 K940390 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
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.
- K940390: Impact, Matrix Technologies Corp. (1994) Summary page 1.
- K961694: Impact, Matrix Technologies Corp. (1996) Summary page 1.
- K970616: Mini Sampler Processor, Cavro Scientific Instruments, Inc. (1997) Summary page 1.

## Most influential descendants
- K052481: BD Viper System (2005), 0 descendants of its own

## Indications for use
The BD Viper instrument is intended for use as a sample processor designed for use with the BD ProbeTec ET system and the BD ProbeTec ET Chlamydia trachomatis and Neisseria gonorrhoeae assays. The BD Viper instrument automates the transfer and mixing of manually prepared and lysed samples. The BD Viper instrument incorporates heating blocks to perform assay priming and prewarming incubation steps prior to the removal and transfer of the microwells to the BD ProbeTec ET instrument for amplification and detection.

Source page: https://510kreport.com/device/K023955
Methodology: https://510kreport.com/methodology