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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
FUJIREBIO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO CLINICAL DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 93 95
2021 69 69
2022 83 83
2023 129 129
2024 122 122
2025 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 408 410
Low Test Results 62 62
Non Reproducible Results 35 35
Incorrect, Inadequate or Imprecise Result or Readings 19 19
No Apparent Adverse Event 13 13
Incorrect Measurement 4 4
Manufacturing, Packaging or Shipping Problem 2 2
Product Quality Problem 1 1
Erratic Results 1 1
Insufficient Information 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 418 418
No Known Impact Or Consequence To Patient 67 69
No Consequences Or Impact To Patient 14 14
Insufficient Information 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Jun-02-2020
2 Roche Diagnostics Operations, Inc. II Mar-05-2020
3 Siemens Healthcare Diagnostics, Inc. II Sep-11-2024
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