PMA P980041S002
- Device
- ACCESS AFP ASSAY ON THE SYNCHRON LXI 725 SYSTEM
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P980041
- Supplement
- S002
- Product code
- LOK
- Decision date
- 2002-12-06
- Classification
- Kit, Test, Alpha-fetoprotein For Neural Tube Defects
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- APPROVAL FOR EXPANDING THE USE OF THE AFP IMMUNOASSAY ON THE SYNCHRON LXI 725 SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADENAME ACCESS AFP IMMUNOASSAY SYSTEM AND IS INDICATED FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN: 1) HUMAN SERUM, AS AN AID IN THE MANAGEMENT OF PATIENTS WITH NON-SEMINOMATOUS TESTICULAR CANCER. 2) MATERNAL SERUM AND AMNIOTIC FLUID AT 15 TO 20 WEEKS GESTATION, TO AID IN THE DETECTION OF FETAL OPEN NEURAL TUBE DEFECTS (ONTD). TEST RESULTS, WHEN USED IN CONJUNCTION WITH ULTRASONOGRAPHY, ARE SAFE AND EFFECTIVE AIDS IN THE DETECTION OF FETAL ONTD. THE ASSAY IS INTENDED FOR USE IN CONJUNCTION WITH OTHER DIAGNOSTIC TOOLS SUCH AS ULTRASOUND AND AMNIOGRAPHY.
Current openFDA PMA Record#
- Device
- ACCESS AFP ASSAY ON THE SYNCHRON LXI 725 SYSTEM
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P980041
- Supplement
- S002
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2002-12-06
- Decision code
- APPR
- Date received
- 2002-07-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR EXPANDING THE USE OF THE AFP IMMUNOASSAY ON THE SYNCHRON LXI 725 SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADENAME ACCESS AFP IMMUNOASSAY SYSTEM AND IS INDICATED FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN: 1) HUMAN SERUM, AS AN AID IN THE MANAGEMENT OF PATIENTS WITH NON-SEMINOMATOUS TESTICULAR CANCER. 2) MATERNAL SERUM AND AMNIOTIC FLUID AT 15 TO 20 WEEKS GESTATION, TO AID IN THE DETECTION OF FETAL OPEN NEURAL TUBE DEFECTS (ONTD). TEST RESULTS, WHEN USED IN CONJUNCTION WITH ULTRASONOGRAPHY, ARE SAFE AND EFFECTIVE AIDS IN THE DETECTION OF FETAL ONTD. THE ASSAY IS INTENDED FOR USE IN CONJUNCTION WITH OTHER DIAGNOSTIC TOOLS SUCH AS ULTRASOUND AND AMNIOGRAPHY.