Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 2
BIOFIRE DIAGNOSTICS, LLC
  SUBSTANTIALLY EQUIVALENT 3
GENETIC SIGNATURES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
QIAGEN GMBH
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 26 26
2022 47 47
2023 64 64
2024 45 45

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 140 140
Incorrect, Inadequate or Imprecise Result or Readings 28 28
False Negative Result 11 11
Non Reproducible Results 2 2
Chemical Problem 1 1
Product Quality Problem 1 1
Computer Software Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 167 167
Insufficient Information 13 13
No Consequences Or Impact To Patient 3 3
Stroke/CVA 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BioFire Diagnostics, LLC II Sep-30-2024
2 BioFire Diagnostics, LLC II Aug-06-2024
3 BioFire Diagnostics, LLC II Feb-15-2024
4 BioFire Diagnostics, LLC II Jan-10-2024
5 BioFire Diagnostics, LLC II Apr-14-2023
6 BioFire Diagnostics, LLC II Mar-15-2023
7 BioFire Diagnostics, LLC II Mar-06-2020
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
-
-