AutoDELFIA hAFP Test System

Kit, Test, Alpha-fetoprotein For Neural Tube Defects

FDA Premarket Approval P970037 S010

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

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.

DeviceAutoDELFIA hAFP Test System
Classification NameKit, Test, Alpha-fetoprotein For Neural Tube Defects
Generic NameKit, Test, Alpha-fetoprotein For Neural Tube Defects
ApplicantPerkinElmer, Inc.
Date Received2017-05-11
Decision Date2017-06-07
PMAP970037
SupplementS010
Product CodeLOK
Advisory CommitteeImmunology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address PerkinElmer, Inc. 940 Winter Street waltham, MA 02451

Supplemental Filings

Supplement NumberDateSupplement Type
P970037Original Filing
S012 2021-07-15 30-day Notice
S011 2018-08-09 30-day Notice
S010 2017-05-11 30-day Notice
S009 2016-07-27 30-day Notice
S008 2012-05-15 30-day Notice
S007 2011-09-23 135 Review Track For 30-day Notice
S006 2011-06-13 30-day Notice
S005 2011-03-17 30-day Notice
S004 2011-02-02 30-day Notice
S003 2010-03-01 Normal 180 Day Track
S002 2008-09-17 Normal 180 Day Track
S001 2002-10-18 Special (immediate Track)

NIH GUDID Devices

Device IDPMASupp
06438147321322 P970037 000
06438147321315 P970037 000

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