# K140447: BD Viper LT System

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: May 20, 2014 after 88 days
- Product code: OOI (Real Time Nucleic Acid Amplification System)
- Device class: 2
- Regulation: 21 CFR 862.2570
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003395 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081825: BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified Dna Assay, Becton, Dickinson & CO (2008) Summary page 1.

## Recalls of this device
- Dec 14, 2015 · Class II · Z-1866-2017: BD has confirmed reports that lower than expected RFU values were generated on customer BD Viper LT Systems after the installation of software version 3.00H. As RFU values decrease, results approach t
- Nov 7, 2014 · Class II · Z-1816-2015: Potential for false positive Chlamydia trachomatis (CT) results and Neisseria gonorrhoeae (GC) results when processing the CT Qx and GC Qx Assays on the BD Viper LT Instrument.

## Indications for use
The BD Viper LT System is intended for in vitro diagnostic (IVD) use in clinical laboratories to perform automated extraction of nucleic acids from multiple specimen types, amplification of target nucleic acid sequences by Strand Displacement Amplification (SDA) and detection of amplified nucleic acid using a two color fluorescence detection system. The BD Viper LT is for use only with in vitro diagnostic tests labeled for use on the system.

Source page: https://510kreport.com/device/K140447
Methodology: https://510kreport.com/methodology