Atellica® IM Alpha Fetoprotein (AFP) Assay

FDA Premarket Approval P930036 S018

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 for an extension to the on-board stability claim for the assay on the atellica im analyzer

DeviceAtellica® IM Alpha Fetoprotein (AFP) Assay
Generic NameKit, Test, Alpha-fetoprotein For Neural Tube Defects
Date Received2021-08-11
Decision Date2021-11-09
Product CodeLOK 
Advisory CommitteeImmunology
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address SIEMENS HEALTHCARE DIAGNOSTICS INC. 333 Coney Street east Walpole, MA 02032

Supplemental Filings

Supplement NumberDateSupplement Type
P930036Original Filing
S018 2021-08-11 Real-time Process
S017 2021-07-26 30-day Notice
S016 2021-04-01 30-day Notice
S015 2020-07-31 30-day Notice
S014 2020-03-09 30-day Notice
S013 2020-02-21 30-day Notice
S011 2019-02-01 30-day Notice
S010 2018-12-06 Normal 180 Day Track
S009 2018-07-27 Real-time Process
S008 2017-09-01 Normal 180 Day Track
S007 2016-10-20 135 Review Track For 30-day Notice
S006 2015-07-17 Normal 180 Day Track
S005 2012-03-26 Normal 180 Day Track No User Fee
S004 2012-02-15 135 Review Track For 30-day Notice
S003 2005-07-22 Real-time Process
S002 2002-01-16 Real-time Process
S001 1998-05-01 Real-time Process


Device IDPMASupp
00630414597720 P930036 001
00630414124797 P930036 001
00630414124933 P930036 001
00630414124940 P930036 001
00630414126319 P930036 001
00630414177328 P930036 001
00630414177335 P930036 001
00630414022963 P930036 001
00630414238791 P930036 008
00630414238807 P930036 008

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