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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device real time nucleic acid amplification system
Regulation Description Instrumentation for clinical multiplex test systems.
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.
Product CodeOOI
Regulation Number 862.2570
Device Class 2


Premarket Reviews
ManufacturerDecision
BD
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
LUMINEX CORPORATION
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Device operates differently than expected 2
False positive result 1
Device displays error message 1
Total Device Problems 4

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 3 0 2 1 1 0
Class III 0 0 0 0 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Molecular II Oct-14-2011
2 Becton Dickinson & Co. II Jun-18-2015
3 Roche Diagnostics Operations, Inc. II Apr-01-2013
4 Roche Diagnostics Operations, Inc. II Mar-14-2011
5 Roche Molecular Systems, Inc. II Feb-26-2014
6 Roche Molecular Systems, Inc. II May-21-2013
7 Roche Molecular Systems, Inc. III Aug-08-2012
8 bioMerieux, Inc. II Jul-06-2011

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