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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.
 
DeviceTANDEM-MP PSA IMMUNOENZYMETRIC ASSAY
Generic NamePROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
Regulation Number866.6010
ApplicantBeckman Coulter, Inc.
250 S. Kraemer Blvd. M/S
W-110
Brea, CA 92822
PMA NumberP850048
Supplement NumberS015
Date Received07/12/1999
Decision Date08/03/1999
Product Code LTJ 
Advisory Committee Immunology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The 30-day Notice requested a change in a raw material from bovine serum to bovine serum albumin, which is used in the manufacture of a component in the Tandem(R)-MP PSA kit to improve the consistency between lots. In addition, a change in the microplate vendor to permit an additional source of microplates and to reduce manufacturing costs.
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