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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, epithelial ovarian tumor associated antigen (he4)
Definition An enzyme immunometric assay for the quantitative determination of HE4 in human serum. The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer. It is not intended to estimate or assess the risk of disease outcomes of patients.
Product CodeOIU
Regulation Number 866.6010
Device Class 2


Premarket Reviews
ManufacturerDecision
FUJIREBIO DIAGNOSTICS, INC
  SUBSTANTIALLY EQUIVALENT 1
FUJIREBIO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1
2016 1 1
2019 1 1
2022 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 4 4
Low Readings 1 1
Audible Prompt/Feedback Problem 1 1
False Negative Result 1 1
High Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
No Known Impact Or Consequence To Patient 2 2
No Consequences Or Impact To Patient 1 1

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