|Trade Name||IMMULITE AFP AND IMMULITE 2000 AFP|
|Classification Name||kit, test, alpha-fetoprotein for neural tube defects|
|Applicant||SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS|
|Supplement Type||real-time process|
|Supplement Reason|| design change - minor|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for use of the immulite afp on the immulite 1000 automated analyzer. The device, as modified, will be marketed under the trade name immulite/ immulite 1000 afp and is indicated: for in vitro diagnostic use with the immulite and immulte 1000 analyzers - 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) measurements 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.