Cleared Traditional

K140447 - BD VIPER LT SYSTEM (FDA 510(k) Clearance)

K140447 · Becton, Dickinson and Company · Microbiology device
May 2014
Decision
88d
Days
Class 2
Risk

K140447 is an FDA 510(k) clearance for the BD VIPER LT SYSTEM. This device is classified as a Real Time Nucleic Acid Amplification System (Class II - Special Controls, product code OOI).

Submitted by Becton, Dickinson and Company (Sparks, US). The FDA issued a Cleared decision on May 20, 2014, 88 days after receiving the submission on February 21, 2014.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 862.2570. 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..

Submission Details

510(k) Number K140447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2014
Decision Date May 20, 2014
Days to Decision 88 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code OOI — Real Time Nucleic Acid Amplification System
Device Class Class II - Special Controls
CFR Regulation 21 CFR 862.2570
Definition 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.