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 gram-positive bacteria and their resistance markers
Definition A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures.
Product CodePAM
Regulation Number 866.3365
Device Class 2


Premarket Reviews
ManufacturerDecision
GENMARK DIAGNOSTICS, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
GREAT BASIN SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ICUBATE, INC
  SUBSTANTIALLY EQUIVALENT 1
NANOSPHERE, INC
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1
2020 2 2
2021 2 2
2022 1 1
2023 106 106
2024 334 334

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 407 407
False Negative Result 36 36
No Apparent Adverse Event 2 2
Volume Accuracy Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 400 400
Insufficient Information 42 42
Death 1 1
Fever 1 1
Unspecified Infection 1 1
Phlebitis 1 1
Renal Failure 1 1
Sepsis 1 1
Toxicity 1 1
Respiratory Failure 1 1
Heart Failure/Congestive Heart Failure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BioFire Diagnostics, Inc. II Jun-20-2014
2 BioFire Diagnostics, LLC II Oct-30-2018
3 Great Basin Scientific, Inc. II Jan-19-2017
4 Luminex Corporation II Dec-06-2023
5 Luminex Corporation II Nov-20-2020
6 Luminex Corporation II Aug-10-2020
7 Luminex Corporation III Feb-11-2019
8 Luminex Corporation II Nov-10-2018
9 Nanosphere, Inc. II Sep-30-2014
10 Nanosphere, Inc. II Sep-23-2014
-
-