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 total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Product CodeMTF
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
8 14 6 5 10 1

MDR Year MDR Reports MDR Events
2019 21 21
2020 14 14
2021 46 46
2022 45 45
2023 30 30
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 89 89
Low Test Results 57 57
Incorrect Measurement 13 13
Non Reproducible Results 12 12
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Output Problem 2 2
No Apparent Adverse Event 2 2
Insufficient Information 2 2
Leak/Splash 1 1
No Device Output 1 1
Unable to Obtain Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 130 130
No Consequences Or Impact To Patient 23 23
No Known Impact Or Consequence To Patient 13 13
Osteopenia/ Osteoporosis 9 9
Insufficient Information 4 4
No Code Available 1 1

-
-