ARCHITECT AFP,LN 3P36
FDA premarket approval P120008/S003 · decided 2013-06-12
Approval details
- PMA number
- P120008
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ARCHITECT AFP,LN 3P36
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Abbott Laboratories
- Date received
- 2013-05-13
- Decision date
- 2013-06-12
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- CHANGE FOR THE ADDITION OF A QUALITY CONTROL TEST FOR PROTEIN PURITY OF INCOMING RAW MATERIAL (ALBUMIN BOVINE 30% SOLUTION WITH 0.1% SODIUM AZIDE (BOVINE ALBUMIN SOLUTION) USED IN THE MANUFACTURING OF CONTROLS AND CALIBRATORS FOR THE ARCHITECT AFP ASSAY. DUE TO THE RAW MATERIAL DISTRIBUTOR NOT HAVING A VALIDATED QUALITY CONTROL TEST FOR PROTEIN PURITY, THE ADDITIONAL QUALITY CONTROL TEST WILL BE IMPLEMENTED TO ENSURE THE PROTEIN PURITY OF THE RAW MATERIAL MEETS THE MANUFACTURERS SPECIFICATIONS.
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