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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Classification Namekit, test, alpha-fetoprotein for neural tube defects
Generic Namechemiluminescent immunoassay for in vitro diagnostic quantitation of afp in maternal and amniotic fluid
ApplicantBECKMAN COULTER, INC.
PMA NumberP980041
Supplement NumberS021
Date Received01/08/2013
Decision Date02/06/2013
Product Code
LOK[ Registered Establishments with LOK ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the special clean maintenance procedure that mitigates vitamin b 12 carryover from a wash buffer/ methanol combination to a methanol/di combination and also to use ethanol and methanol interchangeably as part of the special clean maintenance procedure. This special clean procedure would be used with the access afp, hybritech free psa, hybritech psa and hybritech p2psa reagents on the access, access 2, synchron lxi 725, and unicel dxc 600i integrated clinical systems.
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