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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, test, carbohydrate antigen (ca19-9), for monitoring and management of pancreatic cancer
Regulation Description Tumor-associated antigen immunological test system.
Definition An in vitro diagnostic test for the quantitative measurement of the CA 19-9 tumor associated antigen in human serum or plasma. The test is intended as an aid in the management of patients with confirmed pancreatic cancer and serial monitoring of their response to therapy and disease progression. The test should only be used in patients with serum and plasma CA 19-9 values above the cut-off at the time of diagnosis and in conjunction with other clinical methods.
Product CodeNIG
Regulation Number 866.6010
Device Class 2


Premarket Reviews
ManufacturerDecision
ORTHO CLINICAL DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 69 69
2022 83 84
2023 129 129
2024 121 121
2025 100 100
2026 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 421 422
Low Test Results 60 60
Non Reproducible Results 51 51
Incorrect, Inadequate or Imprecise Result or Readings 29 29
Incorrect Measurement 4 5
Insufficient Information 3 3
Erratic Results 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Mechanical Problem 1 1
Unable to Obtain Readings 1 1
Product Quality Problem 1 1
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 502 503
Insufficient Information 5 5
No Known Impact Or Consequence To Patient 3 3
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc. II Sep-11-2024
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