PMA P090026S004

Device: ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Applicant: Beckman Coulter, Inc.
PMA number: P090026
Supplement: S004
Product code: OYA
Decision date: 2013-02-06
Classification: P2psa
Generic name: P2psa
Approval order statement: CHANGE TO THE SPECIAL CLEAN MAINTENANCE PROCEDURE THAT MITIGATES VITAMIN B 12 CARRYOVER FROM A WASH BUFFER/ METHANOL COMBINATION TO A METHANOL/DI COMBINATION AND ALSO TO USE ETHANOL AND METHANOL INTERCHANGEABLY AS PART OF THE SPECIAL CLEAN MAINTENANCE PROCEDURE. THIS SPECIAL CLEAN PROCEDURE WOULD BE USED WITH THE ACCESS AFP, HYBRITECH FREE PSA,HYBRITECH PSA AND HYBRITECH P2PSA REAGENTS ON THE ACCESS, ACCESS 2, SYNCHRON LXI 725, AND UNICEL DXC 600I INTEGRATED CLINICAL SYSTEMS.

Current openFDA PMA Record#

Device: ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Applicant: Beckman Coulter, Inc.
PMA number: P090026
Supplement: S004
Product code: OYA
Generic name: P2psa
Decision date: 2013-02-06
Decision code: OK30
Date received: 2013-01-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO THE SPECIAL CLEAN MAINTENANCE PROCEDURE THAT MITIGATES VITAMIN B 12 CARRYOVER FROM A WASH BUFFER/ METHANOL COMBINATION TO A METHANOL/DI COMBINATION AND ALSO TO USE ETHANOL AND METHANOL INTERCHANGEABLY AS PART OF THE SPECIAL CLEAN MAINTENANCE PROCEDURE. THIS SPECIAL CLEAN PROCEDURE WOULD BE USED WITH THE ACCESS AFP, HYBRITECH FREE PSA,HYBRITECH PSA AND HYBRITECH P2PSA REAGENTS ON THE ACCESS, ACCESS 2, SYNCHRON LXI 725, AND UNICEL DXC 600I INTEGRATED CLINICAL SYSTEMS.