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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
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
ORTHO CLINICAL DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 117 117
2015 29 29
2016 69 69
2017 98 98
2018 58 58
2019 135 135
2020 93 95
2021 69 69
2022 83 83
2023 129 129
2024 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 625 627
Low Test Results 84 84
Incorrect Or Inadequate Test Results 54 54
No Apparent Adverse Event 50 50
Adverse Event Without Identified Device or Use Problem 44 44
Non Reproducible Results 37 37
Incorrect, Inadequate or Imprecise Result or Readings 22 22
High Readings 9 9
Off-Label Use 7 7
False Positive Result 5 5
Incorrect Measurement 4 4
False Negative Result 2 2
Insufficient Information 1 1
Mechanical Problem 1 1
Product Quality Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 403 405
No Clinical Signs, Symptoms or Conditions 308 308
No Consequences Or Impact To Patient 161 161
Test Result 23 23
No Code Available 16 16
Insufficient Information 3 3
Misdiagnosis 3 3
Death 2 2
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Jun-29-2012
2 Beckman Coulter Inc. II Jun-02-2020
3 Beckman Coulter Inc. II Jun-28-2017
4 BioCheck Inc II Mar-11-2011
5 ORTHO-CLINICAL DIAGNOSTICS II Aug-11-2014
6 Roche Diagnostics Operations, Inc. II Mar-05-2020
7 Siemens Healthcare Diagnostics, Inc II Nov-17-2016
8 Siemens Healthcare Diagnostics, Inc II Dec-11-2012
9 Siemens Healthcare Diagnostics, Inc II Jan-11-2012
10 Tosoh Bioscience Inc II Jun-05-2018
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