IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP

Kit, Test, Alpha-fetoprotein For Neural Tube Defects

FDA Premarket Approval P010007

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for immulite afp for use with the immulite analyzer and immulite 2000 afp for use with the immulite 2000 analyzer. These devices are indicated for in vitro diagnostic use for the quantitative measurement of alpha-fetoprotein (afp) in either of two contexts: a) serial measurements in human serum to aid in the management of patients with nonseminomatous testicular cancer: or b) measurement in maternal serum and amniotic fluid during gestational weeks 15 through 20 - used in conjunction with ultrasonography or amniography - to aid in detection of fetal open neural tube defects.

Device	IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP
Classification Name	Kit, Test, Alpha-fetoprotein For Neural Tube Defects
Generic Name	Kit, Test, Alpha-fetoprotein For Neural Tube Defects
Applicant	SIEMENS HEALTHCARE DIAGNOSTICS INC.
Date Received	2001-02-13
Decision Date	2001-11-09
Notice Date	2001-12-05
PMA	P010007
Supplement	S
Product Code	LOK
Docket Number	01M-0537
Advisory Committee	Immunology
Expedited Review	No
Combination Product	No
Applicant Address	SIEMENS HEALTHCARE DIAGNOSTICS INC. 511 Benedict Ave. tarrytown, NY 10591
Summary:	Summary of Safety and Effectiveness
Labeling:	Labeling Labeling Part 2
Approval Order:	Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P010007		Original Filing
S017	2022-09-15	30-day Notice
S016
S015	2022-02-28	30-day Notice
S014	2021-04-14	30-day Notice
S013	2020-08-12	30-day Notice
S012	2020-07-23	30-day Notice
S011	2019-11-25	30-day Notice
S010	2018-09-28	Real-time Process
S009	2012-05-30	135 Review Track For 30-day Notice
S008	2011-12-19	135 Review Track For 30-day Notice
S007	2011-08-16	30-day Notice
S006	2011-08-08	30-day Notice
S005	2011-02-18	Real-time Process
S004	2009-11-02	Normal 180 Day Track No User Fee
S003
S002	2003-12-12	Real-time Process
S001	2003-01-21	Real-time Process

NIH GUDID Devices

Device ID	PMA	Supp
00630414963594	P010007	001
00630414961040	P010007	001
00630414961033	P010007	001
00630414953519	P010007	001