CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5

K030616 · Microgenics Corp. · LAS · Mar 31, 2003 · Clinical Toxicology

Device Facts

• Record ID: K030616
• Device Name: CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5
• Applicant: Microgenics Corp.
• Product Code: LAS · Clinical Toxicology
• Decision Date: Mar 31, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Intended Use

The CEDIA® Cyclosporine Plus High Range Controls 4 and 5 are in-vitro diagnostic medical devices intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine.

Device Story

CEDIA® Cyclosporine Plus High Range Controls 4 and 5 are in-vitro diagnostic quality control materials. Used by laboratory personnel to monitor precision of cyclosporine testing procedures. Controls are assayed, providing known values to verify assay performance and ensure accuracy of patient test results. Used in clinical laboratory environments as part of standard quality assurance protocols.

Clinical Evidence

No clinical data provided; device is an in-vitro diagnostic quality control material.

Technological Characteristics

In-vitro diagnostic quality control material; assayed for cyclosporine; liquid form; intended for use with clinical laboratory testing procedures.

Indications for Use

Indicated for use as an assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine in clinical laboratory settings.

Regulatory Classification

Identification

A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 3 1 2003

Rueyming Loor, Ph.D. Senior Director, Research and Development Microgenics Corporation 46360 Fremont Blvd Fremont, CA 94538

k030616 Re: Trade/Device Name: CEDIA® Cyclosporine Plus High Range Controls 4 and 5 Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: LAS Dated: February 25, 2003 Received: February 26, 2003

Dear Dr. Loor:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## ATTACHMENT E

## INDICATIONS FOR USE STATEMENT

KO30616

510(K) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: CEDIA® Cyclosporine Plus High Range Controls 4 and 5

Indications For Use:

The CEDIA® Cyclosporine Plus High Range Controls 4 and 5 are in-vitro diagnostic medical devices intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine.

T. Can Cooper

(Diyision Sign-Off) Division of Clinical Laboratory De 510(k) Number --

Prescription Use X