• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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

MDR Year MDR Reports MDR Events
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 398 400
Low Test Results 52 52
No Apparent Adverse Event 49 49
Non Reproducible Results 35 35
Incorrect, Inadequate or Imprecise Result or Readings 16 16
Off-Label Use 7 7
High Readings 7 7
Incorrect Measurement 4 4
Product Quality Problem 1 1
Mechanical Problem 1 1
Insufficient Information 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 308 308
No Known Impact Or Consequence To Patient 176 178
No Consequences Or Impact To Patient 39 39
Insufficient Information 3 3
Test Result 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Jun-02-2020
2 Roche Diagnostics Operations, Inc. II Mar-05-2020
-
-