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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
FUJIREBIO DIANOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 69 69
2017 98 98
2018 58 58
2019 135 135
2020 93 95
2021 47 47

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 304 306
Low Test Results 50 50
No Apparent Adverse Event 50 50
Adverse Event Without Identified Device or Use Problem 41 41
Incorrect Or Inadequate Test Results 35 35
Non Reproducible Results 21 21
High Readings 8 8
Off-Label Use 7 7
Incorrect, Inadequate or Imprecise Resultor Readings 4 4
Incorrect Measurement 2 2
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 346 348
No Consequences Or Impact To Patient 80 80
No Clinical Signs, Symptoms or Conditions 59 59
No Code Available 13 13
Test Result 2 2
Misdiagnosis 2 2
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Jun-02-2020
2 Beckman Coulter Inc. II Jun-28-2017
3 Roche Diagnostics Operations, Inc. II Mar-05-2020
4 Siemens Healthcare Diagnostics, Inc II Nov-17-2016
5 Tosoh Bioscience Inc II Jun-05-2018
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