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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device gram-negative bacteria and associated resistance markers
Regulation Description Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.
Definition A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures.
Product CodePEN
Regulation Number 866.3365
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOFIRE DIAGNOSTICS, LLC
  SUBSTANTIALLY EQUIVALENT 3
GENMARK DIAGNOSTICS, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ICUBATE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 5 5
2020 4 4
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 5 5
False Negative Result 3 3
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Insufficient Information 1 1
Electrical /Electronic Property Problem 1 1
Failure to Fold 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Death 5 5
Insufficient Information 3 3
Renal Failure 2 2
Sepsis 1 1
Septic Shock 1 1
Cardiogenic Shock 1 1
Unspecified Infection 1 1
Renal Disease, End Stage 1 1
Bacterial Infection 1 1
Cardiac Arrest 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BioFire Diagnostics, LLC II Nov-30-2021
2 BioFire Diagnostics, LLC II Aug-12-2021
3 BioFire Diagnostics, LLC II Jun-21-2021
4 BioFire Diagnostics, LLC II Mar-01-2021
5 BioFire Diagnostics, LLC II Jun-08-2020
6 BioFire Diagnostics, LLC II Apr-12-2019
7 BioFire Diagnostics, LLC II Apr-25-2018
8 Luminex Corporation II Nov-20-2020
9 Luminex Corporation II Aug-10-2020
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