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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.
 
DeviceElecsys free PSA Test System, Biotin remediation
Generic NameTest, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
ApplicantRoche Diagnostics Corp.
9115 Hague Rd.
Indianapolis, IN 46250
PMA NumberP000027
Supplement NumberS035
Date Received11/27/2019
Decision Date05/12/2020
Product Code MTG 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the update of the Elecsys free PSA immunoassay to improve the tolerance to biotin interference.
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