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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instrumentation for clinical multiplex test systems
Regulation Description Instrumentation for clinical multiplex test systems.
Definition Instrumentation for clinical multiplex test systems is a device that is intended to measure and sort multiple signals generated by an assay from a clinical sample. The generated signals from multiple probes or other ligands may be measured by fluorescence, luminescence, or other physical or chemical properties. The device may integrate scanning, reagent handling, hybridization, washing, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. This instrumentation is used with specific assays to comprise an assay test system to measure multiple analytes of a similar chemical nature for de
Product CodeNSU
Regulation Number 862.2570
Device Class 2


Premarket Reviews
ManufacturerDecision
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 1
LUMINEX MOLECULAR DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Device operates differently than expected 15
Incorrect or inadequate result 6
Device displays error message 4
Data Issue 4
Overheating of device or device component 2
Device stops intermittently 2
Burn of device or device component 2
Contamination during use 1
Material discolored 1
Disconnection 1
Device emits odor 1
Incorrect or inadequate test results 1
Connection issue 1
Loss of Data 1
Device sensing issue 1
Improper device output 1
Output issue 1
No Information 1
Total Device Problems 46

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 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0


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