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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, colorectal neoplasia, dna methylation and hemoglobin detection
Definition The colorectal neoplasia DNA methylation and hemoglobin detection system is a qualitative, non-invasive device used to screen for the detection of methylation of specific DNA markers associated with colorectal cancer and for the presence of occult hemoglobin in human specimens, including stool, blood, urine, and buccal swabs. It is intended as an aid in the detection of colorectal cancer or advanced adenomas in conjunction with diagnostic colonoscopy. It is indicated for use in adults 50 years or older, who are typical average-risk candidates for colorectal cancer (CRC) screening.
Product CodePHP
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
6 4 2 6 16 1

MDR Year MDR Reports MDR Events
2021 5 5
2022 5 5
2023 1 1
2024 4 4
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 4 4
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Product Quality Problem 2 2
False Negative Result 1 1
Incomplete or Missing Packaging 1 1
Device Markings/Labelling Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Missing Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 8 8
No Clinical Signs, Symptoms or Conditions 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Weight Changes 1 1
Anxiety 1 1
Cancer 1 1

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