AUTODELFIA XPRESS HAFP TEST SYSTEM

Kit, Test, Alpha-fetoprotein For Neural Tube Defects

FDA Premarket Approval P970037 S003

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

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 is to be performed on the 6000 delfia xpress clinical random access screening platform and is intended for use only in conjunction with other diagnostic tools such as ultrasound and amniography as an aid in the detection of open neural tube defects (ontds).

DeviceAUTODELFIA XPRESS HAFP TEST SYSTEM
Classification NameKit, Test, Alpha-fetoprotein For Neural Tube Defects
Generic NameKit, Test, Alpha-fetoprotein For Neural Tube Defects
ApplicantPerkinElmer, Inc.
Date Received2010-03-01
Decision Date2011-01-12
PMAP970037
SupplementS003
Product CodeLOK
Advisory CommitteeImmunology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
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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