510(k) K140447

BD VIPER LT SYSTEM by Becton, Dickinson and Company — Product Code OOI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 20, 2014
Date Received: February 21, 2014
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Real Time Nucleic Acid Amplification System
Device Class: Class II
Regulation Number: 862.2570
Review Panel: CH
Submission Type

The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. The system is used with specific assays to comprise an assay test system.

Other clearances by Becton, Dickinson and Company

K252040 — BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Bloo (March 13, 2026)
K250884 — 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe (December 2, 2025)
K250358 — BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus fo (October 31, 2025)
K250059 — BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O) (September 12, 2025)
K251713 — BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) (August 8, 2025)
K251350 — BD Plastipak Syringe (July 29, 2025)
K243207 — BD Vacutainer® Eclipse Blood Collection Needle (July 3, 2025)
K243872 — BD Veritor System for SARS-CoV-2 (June 16, 2025)
K250447 — BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 1 (May 19, 2025)
K243649 — BD Vacutainer® Multiple Sample Luer Adapter (March 21, 2025)

Other clearances for product code OOI

K243922 — Revogene (March 20, 2025)
K222779 — Revogene (January 26, 2023)
K220480 — Revogene (July 11, 2022)
K170558 — revogene (May 25, 2017)
K161495 — ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 (June 30, 2016)
K160517 — ARIES System (April 12, 2016)
K151917 — ARIES System (October 6, 2015)
K151690 — Alere i Instrument, Alere i Influenza A & B, Alere i Strep A (July 16, 2015)
K123955 — QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT (March 8, 2013)
K113319 — ROTOR-GENE Q MDX (February 6, 2012)