AutoDELFIA hAFP Test System
FDA premarket approval P970037/S010 · decided 2017-06-07
Approval details
- PMA number
- P970037
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AutoDELFIA hAFP Test System
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Revvity, Inc.
- Date received
- 2017-05-11
- Decision date
- 2017-06-07
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Waltham, MA
- 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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