MAS IMMUNOSUPPRESSANT CONTROLS

K051074 · Microgenics Corp. · LAS · Jun 6, 2005 · Clinical Toxicology

Device Facts

• Record ID: K051074
• Device Name: MAS IMMUNOSUPPRESSANT CONTROLS
• Applicant: Microgenics Corp.
• Product Code: LAS · Clinical Toxicology
• Decision Date: Jun 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Intended Use

The MAS Immunosuppressant Controls, consisting of levels 1 through 3, are in-vitro diagnostic medical devices intended for use as assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine, sirolimus, and tacrolimus.

Device Story

MAS Immunosuppressant Controls are liquid, processed human whole blood-based quality control materials; used by laboratory professionals to monitor precision of clinical assays for cyclosporine, sirolimus, and tacrolimus. Device consists of three levels with specific analyte concentrations; targets established via gravimetric primary reference standards and confirmed by LC-MS/MS. Controls are stored at -20°C; once thawed, stable for 14 days at 2-8°C. Healthcare providers use these controls to verify assay performance; results ensure reliability of patient immunosuppressant drug monitoring.

Clinical Evidence

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

Technological Characteristics

Processed human whole blood matrix; liquid form; contains cyclosporine, sirolimus, and tacrolimus; three levels; 14-day open-vial stability at 2°C to 8°C; stored at -20°C until expiration.

Indications for Use

Indicated for use as an assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine, sirolimus, and tacrolimus. Intended for prescription use 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.

Predicate Devices

• Lyphochek® Whole Blood Control (K022041)

Submission Summary (Full Text)

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K051074

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]

#### Contact Person:

Lisa Charter Research and Development 46360 Fremont Blvd. Telephone: [phone] Facsimile: [phone]

## Preparation Date:

April 25, 2005

#### Device Information:

| Device Classification Name: | Drug Specific Control Materials |
|-----------------------------|--------------------------------------|
| Common/Usual Name: | Immunosuppressive Drug Control |
| Proprietary Name: | MAS® Immunosuppressant Controls |
| Regulation Number: | 21 CFR§862.3280 |
| Regulatory Name: | Clinical toxicology control material |
| Product Code: | LAS |
| Regulatory Class: | Class I |

## Predicate Devices:

Lyphochek® Whole Blood Control (K022041) manufactured by Bio-Rad Laboratories.

## Device Description:

MAS Immunosuppressant Controls is prepared from human whole blood, with pure chemicals and stabilizers. The control is provided in a liquid form containing Cyclosporine, Sirolimus, and Tacrolimus.

#### Intended Use:

The MAS Immunosuppressant Controls, consisting of levels 1 through 3, are in-vitro diagnostic medical devices intended for use as assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine, sirolimus, and tacrolimus.

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# Comparison to Predicate Device(s):

The Microgenics Cyclosporine Controls are substantially equivalent to Lyphochek® Whole Blood
States and Children of States Also Die Rodd Charatariae The Microgenios Oyeloopenhoed by Bio-Rad Laboratories.

| Device | Subject Device | Predicated Device |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | | (K022041) |
| Intended Use | The MAS<br>Immunosuppressant<br>Controls, consisting<br>of levels 1 through<br>3, are in-vitro<br>diagnostic medical<br>devices intended for<br>use as assayed<br>quality control<br>material to monitor<br>the precision of<br>laboratory testing<br>procedures for<br>cyclosporine,<br>sirolimus, and<br>tacrolimus. | Lyphochek® Whole<br>Blood Control is<br>intended for use as<br>an assayed quality<br>control material to<br>monitor the<br>precision of<br>laboratory testing<br>procedures for<br>cyclosporine, lead,<br>red cell folate,<br>tacrolimus, and<br>sirolimus. |
| Matrix | Processed Human<br>Whole Blood | Processed Human<br>Whole Blood |
| Form | Liquid | Lyophilized |
| Analytes | Cyclosporine,<br>Sirolimus,<br>Tacrolimus | Cyclosporine,<br>Lead, Red Cell<br>Folate, Tacrolimus,<br>Sirolimus |
| Levels | Three (3) Levels | Three (3) Levels |
| Open Vial<br>Claim | 14 days at 2°C to<br>8°C | 14 days at 2°C to<br>8°C. Exception:<br>Red cell folate is<br>stable for 3 days at<br>2°C to 8°C |
| Storage | -20°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<br>date noted on vial<br>label. |

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#### Summary:

The information provided in this pre-market notification demonstrates that the MAS Immunosuppressant Controls 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 premarket notification provides reasonable assurance the MAS Immunosuppressant Controls are safe and effective for the stated intended use.

MAS® is a registered trademark of Medical Analysis Systems, Inc.

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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 stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 6 - 2005

Ms. Lisa Charter Research and Development Microgenics Corporation 46360 Fremont Blvd Fremont, CA 94538

k051074 Re: Trade/Device Name: MAS Immunosuppressant Controls Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: LAS Dated: April 25, 2005 Received: April 29, 2005

Dear Ms. Charter:

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/industry/support/index.html.

Sincerely yours,

Carol C. Benem

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): Kos S 10 7 4

Device Name: MAS Immunosuppressant Controls

Indications For Use:

The MAS Immunosuppressant Controls, consisting of levels 1 through 3, are in-vitro The MAG inimal our less intended for use as assayed quality control material to ulughoutio modifical us no folaboratory testing procedures for cyclosporine, sirolimus, and tacrolimus.

X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Q. Chalu

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K051074

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