COBAS INTEGRA 400 PLUS CYCLOSPORINE

Cyclosporine

FDA Premarket Approval P920031 S003

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.

Pre-market Approval Supplement Details

Approval for expanding the use of the cobas integra cyclosporine reagent to the cobas integra 400 plus analyzer. The device, as modified, will be marketed under the trade name cobas integra cyclosporine and is indicated for quantitative determination of cyclosporine in whole blood as an aid in the management of cyclosporine therapy in kidney, heart and liver transplant patients.

• Device: COBAS INTEGRA 400 PLUS CYCLOSPORINE
• Classification Name: Cyclosporine
• Generic Name: Cyclosporine
• Applicant: DADE BEHRING, INC.
• Date Received: 2002-05-17
• Decision Date: 2002-07-24
• PMA: P920031
• Supplement: S003
• Product Code: MKW
• Advisory Committee: Toxicology
• Supplement Type: Normal 180 Day Track
• Expedited Review: No
• Combination Product: No
• Applicant Address: DADE BEHRING, INC. po Box 6101 newark, DE 19714-6101

Supplemental Filings

Supplement Number	Date	Supplement Type
P920031		Original Filing
S003	2002-05-17	Normal 180 Day Track
S002	2002-02-20	Real-time Process
S001	1999-07-02	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
00842768001475	P920031	000
00842768001468	P920031	000
00842768001482	P920031	001