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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Generic NameP2psa
ApplicantBeckman Coulter, Inc.
1000 Lake Hazeltine Dr.
Chaska, MN 55318
PMA NumberP090026
Supplement NumberS007
Date Received04/12/2013
Decision Date08/20/2013
Product Code OYA 
Advisory Committee Immunology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR UPDATING THE LABELING OF UNICEL DX1 INSTRUCTIONS FOR USE, OPERATOR'S GUIDE, REFERENCE MANUAL AND ONBOARD SYSTEM HELP. REQUESTED CHANGES TO THE LABELING INCLUDE CHANGING CURRENT CAUTION STATEMENTS TO WARNING STATEMENTS (TO ENHANCE THESAFETY OF THE OPERATOR, AND REMOVING REDUNDANT CAUTION STATEMENTS), ADDING NEW CAUTION STATEMENTS (NOTES FOR PROCEDURE CLARIFICATION), ADDING NEW WARNING STATEMENTS, CHANGING WARNINGTO CAUTION AND RELOCATING EXISTING WARNING/CAUTION STATEMENTS IN ORDER TO ENHANCE THE SAFETY IN THE USE OF THE REAGENTS ON THE UNICEL DXL 800/600 IMMUNOASSAY SYSTEMS AND UNICEL DXC 880I/860I/680I/ 660I SYNCHRON ACCESS INTEGRATED CLINICAL SYSTEMS.
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