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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)
2017 2018 2019 2020 2021 2022
7 4 13 9 6 4

MDR Year MDR Reports MDR Events
2017 1 1
2018 1 1
2019 3 3
2020 1 1
2021 5 5
2022 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 7 7
Incorrect, Inadequate or Imprecise Result or Readings 4 4
False Negative Result 3 3
Product Quality Problem 2 2
Labelling, Instructions for Use or Training Problem 1 1
Incorrect Or Inadequate Test Results 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Known Impact Or Consequence To Patient 2 2
Cancer 2 2
Test Result 1 1
No Code Available 1 1
Death 1 1
Pain 1 1
No Consequences Or Impact To Patient 1 1
Distress 1 1
Weight Changes 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Epigenomics Ag II Mar-16-2018
2 Exact Sciences Corporation II Jun-01-2017
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