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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.
 
DeviceAutoDELFIA hAFP Test System
Generic NameKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
ApplicantRevvity, Inc.
77 4th St.
Waltham, MA 02451
PMA NumberP970037
Supplement NumberS010
Date Received05/11/2017
Decision Date06/07/2017
Product Code LOK 
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  
Changes being made in the hAFP antibody production: 1) use of additional L-glutamine supplement during the production of the coating antibody to the medium that contains nutrients (glucose and glutamine), and setting a recommended minimum concentration of glutamine during the production of the hAFP antibodies; and 2) addition of glutamine and glutamate testing of the routine anti-hAFP antibody production samples to the presently performed glucose and lactate testing.
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