MICROGENICS CYCLOSPORINE CONTROL KIT

K032842 · Microgenics Corp. · LAS · Oct 17, 2003 · Clinical Toxicology

Device Facts

• Record ID: K032842
• Device Name: MICROGENICS CYCLOSPORINE CONTROL KIT
• Applicant: Microgenics Corp.
• Product Code: LAS · Clinical Toxicology
• Decision Date: Oct 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Intended Use

The Microgenics Cyclosporine Controls, consisting of levels 1 through 5, are in-vitro diagnostic medical devices intended for use as assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine.

Device Story

Microgenics Cyclosporine Controls are lyophilized human whole blood-based quality control materials; used to monitor precision of cyclosporine laboratory testing procedures. Device consists of five levels with target concentrations ranging from 70 to 1600 ng/mL. Intended for use by laboratory personnel to verify assay performance. Value assignment performed via replicate analysis using CEDIA Cyclosporine Plus Assay on Hitachi 900 series analyzers. Users are advised to establish laboratory-specific means and ranges.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and comparison of physical properties and intended use to legally marketed predicate devices.

Technological Characteristics

Matrix: Processed human whole blood. Form: Lyophilized. Analytes: Cyclosporine. Stability: 14 days at 2°C to 8°C when reconstituted. Storage: 2°C to 8°C until expiration. Five levels provided.

Indications for Use

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

Predicate Devices

• CEDIA® Cyclosporine Plus High Range Controls 4 and 5 (K030616)
• Lyphochek Whole Blood Control (K022041)

Submission Summary (Full Text)

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K032842

7

# OCT 17 2003

## 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

#### 510(k) Number:

#### Submitter:

Microgenics Corporation 46360 Fremont Blvd Fremont, CA 94538 Telephone: [phone] Facsimile: [phone]

#### Contact Person:

David Casal, Ph.D. Vice-President, Clinical, Regulatory and Quality Affairs Telephone: [phone] Facsimile: [phone]

#### Preparation Date:

September 10, 2003

#### Device Information:

| Device Classification Name: | Drug Specific Contr |
|-----------------------------|---------------------|
| Common/Usual Name: | Cyclosporine Immu |
| Proprietary Name: | Microgenics Cyclos |
| Regulation Number: | 21 CFR§862.3280 |
| Regulatory Name: | Clinical toxicology |
| Product Code: | LAS |
| Regulatory Class: | Class I |

trol Materials unosuppressive Drug Control sporine Controls control material

#### Predicate Devices:

CEDIA® Cyclosporine Plus High Range Controls 4 and 5 (K030616) Lyphochek Whole Blood Control (K022041) manufactured by Bio-Rad Laboratories.

#### Device Description:

The Microgenics Cyclosporine Controls are prepared from whole human blood, with pure chemicals stabilizers added. The control kit includes five separate controls known as C1, C2, C3, C4 and C5 with target concentrations of approximately 70, 200, 350, 700 and 1600

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ng cyclosporine/mL. The Microgenics Cyclosporine Controls are provided in lyophilized form for increased stability.

#### Intended Use:

The Microgenics Cyclosporine Controls, consisting of levels 1 through 5, are in-vitro diagnostic medical devices intended for use as assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine.

#### Comparison to Predicate Device(s):

The Microgenics Cyclosporine Controls are substantially equivalent to the CEDIA® Cyclosporine Plus High Range Controls 4 and 5 (K030616) and the Lyphochek® Whole Blood Control (K022041) manufactured by Bio-Rad Laboratories. Moreover, the Microgenics Cyclosporine Controls are manufactured using methods virtually identical to those used for manufacture of the CEDIA® Cyclosporine Plus High Range Controls 4 and 5.

| Device<br>Characteristics | Subject Device | Predicate Device<br>(K030616) | Predicated Device<br>(K022041) |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Microgenics Cyclospor-<br>ine Controls, consisting<br>of levels 1 through 5, are<br>in-vitro diagnostic<br>medical devices intended<br>for use as assayed quality<br>control material to<br>monitor the precision of<br>laboratory testing<br>procedures for<br>cyclosporine. | CEDIA® Cyclosporine<br>Plus High Range Controls<br>are intended for use as an<br>assayed quality control<br>material to monitor the<br>precision of laboratory<br>procedures for<br>cyclosporine. | Lyphochek® Whole<br>Blood Control is intended<br>for use as an assayed<br>quality control material to<br>monitor the precision of<br>laboratory testing<br>procedures for<br>cyclosporine. |
| Matrix | Processed Human Whole<br>Blood | Processed Human Whole<br>Blood | Processed Human Whole<br>Blood |
| Form | Lyophilized | Lyophilized | Lyophilized |
| Analytes | Cyclosporine | Cyclosporine | Cyclosporine, Lead, Red<br>Call Folate, and<br>Tacrolimus |
| Levels | Five (5) Levels | Two (2) Levels | Three (3) Levels |
| Reconstituted Vial<br>Claim | 14 days at 2°C to 8°C | 14 days at 2°C to 8°C | 14 days at 2°C to 8°C.<br>Exception: Red cell folate<br>is stable for 3 days at 2°C<br>to 8°C |
| Storage | 2°C to 8°C until<br>expiration date | 2°C to 8°C until<br>expiration date | 2°C to 8°C until<br>expiration date |
| Stability | Until expiration date<br>noted on vial label | Until expiration date<br>noted on vial label | Until expiration date<br>noted on vial label |

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### Summary:

The information provided in this pre-market notification demonstrates that the Microgenics Cyclosporine Controls (Assayed and Unassayed) are substantially equivalent to the previously cleared predicate devices. Substantial equivalence was demonstrated through comparison of intended use and physical properties to commercially available devices. The information supplied in this pre-market notification provides reasonable assurance the Microgenics Cyclosporine Controls are safe and effective for the stated intended use.

CEDIA® is a registered trademark of Roche Diagnostics.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with wavy lines below them.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# OCT 17 2003

David Casal, Ph.D. Vice President, Clinical, Regulatory and Quality Affairs Microgenics Corporation 46360 Fremont Blvd. Fremont, CA 94538

Re: k032842

> Trade/Device Name: Microgenics Cyclosporine Controls Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: LAS Dated: September 10, 2003 Received: September 16, 2003

Dear Dr. Casal:

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 (QS) regulation (21 CFR Part 820).

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### Page 2 -

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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# INDICATIONS FOR USE STATEMENT

Ko32842

510(k) Number (if known):

Microgenics Cyclosporine Controls Device name:

#### Indications for Use:

The Microgenics Cyclosporine Controls, consisting of levels 1 through 5, are in-vitro diagnostic medical devices intended for use as assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine.

### PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-the Counter Use_

(per 21 CFR §801.109

9
(Optional Format 1-2-96)

Albert Cooper
**Division Sign-Off** for Tear Cooper

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 303 2842