Cologuard
FDA premarket approval P130017/S051 · decided 2022-04-13
Approval details
- PMA number
- P130017
- Supplement
- S051
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Cologuard
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Applicant
- Exact Sciences Corporation
- Date received
- 2022-03-02
- Decision date
- 2022-04-13
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- PHP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Medison, WI
- Statement
- Approval for a minor change in the wording of the Indications for Use. Cologuard Stool DNA-Based Colorectal Cancer Screening Test is indicated forCologuard is intended for the qualitative detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. Cologuard is for use with the Cologuard® collection kit and the following instruments: BioTek ELx808 Absorbance Microplate Reader; Applied Biosystems 7500 Fast Dx Real-Time PCR; Hamilton Microlab S
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