Cologuard Test Definition v1.4

Cologuard Test Definition v1.4 - 1.4

An in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PHP

Device Name: System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

Device Class: 3

Physical State: The device may be intended for manual or automated assay preparation. It may include specimen collection and preparation kits or reagents, and may utilize an algorithm for result determination.

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.

Submission Type ID: 2

Review Panel: PA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The test uses bisulfite conversion of methylated DNA and polymerase chain reaction to detect methylation of specific DNA markers, and enzymatic detection is used to detect occult hemoglobin.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: human stool, blood, plasma

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 00858637005352

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A