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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cytomegalovirus (cmv) dna quantitative assay
Regulation Description Quantitative cytomegalovirus nucleic acid tests for transplant patient management.
Definition Cytomegalovirus (CMV) DNA Quantitative Assay is an in vitro nucleic acid assay for the quantitative measurement of CMV DNA in human plasma. The assay can be used to measure CMV DNA levels serially at baseline and during the course of antiviral treatment to assess virological response to treatment. The test results must be interpreted within the context of all relevant clinical and laboratory findings.
Product CodePAB
Regulation Number 866.3180
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MOLECULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE MOLECULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
4 9 14 16 0 0

MDR Year MDR Reports MDR Events
2022 1 1
2023 3 3
2024 2 2
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 4 4
Unable to Obtain Readings 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
False Positive Result 1 1
High Test Results 1 1
Low Test Results 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Electrolyte Imbalance 1 1
Dehydration 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hologic, Inc. II Mar-22-2024
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