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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameACCESS AFP IMMUNOASSAY SYSTEM
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
Date Received10/16/1998
Decision Date02/08/1999
Product Code
LOK[ Registered Establishments with LOK ]
Docket Number 99M-0793
Notice Date 04/08/1999
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the access(r) afp reagents on the access(r) immunoassay analyzer. The access(r) afp assay is a paramagnetic particle, chemiluminescent immunoassay for use with the access(r) immunoassay system for the quantitative determination fo alpha-fetoprotein (afp) in: 1)human seru, as an aid in management of patients with non-seminomatous testicular cancer. 2) maternal serum and amniotic fluid at 15 to 20 weeks gestation, to aid in the detection of fetal open neural tube defects (ontd). The assay is intended for use in conjunction with other diagnostic tools such as ultrasound and amniography.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 
S021 S022 S023 
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