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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceIsoPSA® Assay
Generic NameMulti-analyte test system with algorithmic analysis for detection of prostate cancer
ApplicantCleveland Diagnostics, Inc.
3615 Superior Ave., Suite 4407b
Cleveland, OH 44114
PMA NumberP200048
Supplement NumberS001
Date Received04/29/2026
Decision Date07/28/2026
Product Code QRF 
Advisory Committee Immunology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
extension of the shelf-life of the IsoPSA Controls
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