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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gastrointestinal pathogen panel multiplex nucleic acid-based assay system
Definition A gastrointestinal pathogen panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings.
Product CodePCH
Regulation Number 866.3990
Device Class 2


Premarket Reviews
ManufacturerDecision
APPLIED BIOCODE, INC.
  SUBSTANTIALLY EQUIVALENT 2
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 5
BIOFIRE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
BIOFIRE DIAGNOSTICS, LLC
  SUBSTANTIALLY EQUIVALENT 3
CEPHEID
  SUBSTANTIALLY EQUIVALENT 1
GEN-PROBE PRODESSE, INC.
  SUBSTANTIALLY EQUIVALENT 1
GREAT BASIN SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
LUMINEX MOLECULAR DIAGNOSTICS, INC.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 7
NANOSPERE,INC.
  SUBSTANTIALLY EQUIVALENT 1
NANOSPHERE, INC
  SUBSTANTIALLY EQUIVALENT 1
SEROSEP, LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2019 4 4
2021 26 26
2022 47 47
2023 64 64
2024 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 123 123
Incorrect, Inadequate or Imprecise Result or Readings 23 23
False Negative Result 10 10
Non Reproducible Results 2 2
Chemical Problem 1 1
Computer Software Problem 1 1
False Reading From Device Non-Compliance 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 147 147
Insufficient Information 5 5
No Consequences Or Impact To Patient 3 3
No Known Impact Or Consequence To Patient 3 3
No Information 1 1
Stroke/CVA 1 1
Death 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Aug-22-2019
2 BioFire Diagnostics, LLC II Feb-15-2024
3 BioFire Diagnostics, LLC II Jan-10-2024
4 BioFire Diagnostics, LLC II Apr-14-2023
5 BioFire Diagnostics, LLC II Mar-15-2023
6 BioFire Diagnostics, LLC II Mar-06-2020
7 BioFire Diagnostics, LLC II Apr-27-2019
8 Luminex Corporation II Jun-28-2023
9 Luminex Corporation II Jul-06-2022
10 Luminex Corporation II Sep-10-2021
11 Luminex Corporation II Apr-23-2021
12 Luminex Corporation II Oct-11-2018
13 Luminex Molecular Diagnostics II Jun-10-2019
14 Nanosphere, Inc. II Sep-23-2014
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