AUTODELFIA XPRESS HAFP TEST SYSTEM
FDA premarket approval P970037/S003 · decided 2011-01-12
Approval details
- PMA number
- P970037
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AUTODELFIA XPRESS HAFP TEST SYSTEM
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Revvity, Inc.
- Date received
- 2010-03-01
- Decision date
- 2011-01-12
- Days to decision
- 317 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Waltham, MA
- Statement
- APPROVAL TO EXTEND THE AUTODELFIA HAFP KIT ONTO THE DELFIA XPRESS INSTRUMENT. THE MODIFIED VERSION, NAMELY, DELFIA XPRESS HAFP KIT IS DESIGNED TO BE USED WITH THE 6000 DELFIA XPRESS CLINICAL RANDOM ACCESS SCREENING PLATFORM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DELFIA XPRESS HAFP KIT AND IS INDICATED FOR `THE QUANTITATIVE DETERMINATION OF HUMAN ALPHA-FETOPROTEIN (AFP) IN MATERNAL SERUM AND AMNIOTIC FLUID OBTAINED BETWEEN THE 15TH AND 20TH WEEKS OF GESTATION. THE ASSAY I
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