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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prostate-specific antigen (psa) for management of prostate cancers
Regulation Description Tumor-associated antigen immunological test system.
Product CodeLTJ
Regulation Number 866.6010
Device Class 2

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
1 2 0 2 3 1

MDR Year MDR Reports MDR Events
2020 4 4
2021 8 8
2022 11 11
2023 17 17
2024 8 8
2025 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 26 26
Incorrect Measurement 19 19
Low Test Results 15 15
Non Reproducible Results 10 10
Insufficient Information 1 1
Unable to Obtain Readings 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 42 42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
No Known Impact Or Consequence To Patient 3 3
No Consequences Or Impact To Patient 1 1

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