• 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 procalcitonin assay
Definition To aid in decision making on antibiotic therapy, including antibiotic initiation and discontinuation, for inpatients or patients in the Emergency Department, with suspected or confirmed lower respiratory tract infections (LRTI) defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD).
Product CodePRI
Regulation Number 866.3215
Device Class 2


Premarket Reviews
ManufacturerDecision
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 4 4
2020 3 3
2021 157 157
2022 16 16
2023 12 12
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Unable to Obtain Readings 144 144
High Test Results 19 19
Low Test Results 10 10
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Non Reproducible Results 5 5
False Positive Result 4 4
Failure to Calibrate 2 2
False Negative Result 2 2
Nonstandard Device 1 1
High Readings 1 1
Low Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 186 186
No Known Impact Or Consequence To Patient 4 4
No Consequences Or Impact To Patient 2 2
No Patient Involvement 2 2

Recalls
Manufacturer Recall Class Date Posted
1 bioMerieux, Inc. II Dec-28-2021
-
-