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 303 303

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 380 380
False Negative Result 34 34
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 394 394
Insufficient Information 17 17
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
-
-