LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC

K072721 · Bio-Rad, Diagnostics Grp. · DIF · Dec 11, 2007 · Clinical Toxicology

Device Facts

• Record ID: K072721
• Device Name: LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC
• Applicant: Bio-Rad, Diagnostics Grp.
• Product Code: DIF · Clinical Toxicology
• Decision Date: Dec 11, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Intended Use

Lyphochek Whole Blood Immunosuppressant Controls or Abbott Immunosuppressant MCC is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Device Story

Lyphochek Whole Blood Immunosuppressant Controls and Abbott Immunosuppressant MCC are lyophilized, human whole blood-based quality control materials. They contain added chemicals and stabilizers to support the monitoring of laboratory testing precision for immunosuppressant drugs (Cyclosporine, Sirolimus, Tacrolimus). The product is intended for professional use in clinical laboratories. Users reconstitute the lyophilized material and use it to verify the performance of analytical testing procedures. The output is a control value used by laboratory personnel to assess the accuracy and precision of patient sample testing, ensuring reliable clinical decision-making regarding immunosuppressant therapy.

Clinical Evidence

No clinical data. Stability studies were performed to establish shelf life (3 years at 2-8°C) and open-vial stability (14 days at 2-8°C or 30 days at -20 to -70°C).

Technological Characteristics

Lyophilized human whole blood matrix with added chemicals and stabilizers. EDTA anticoagulant. Storage: 2-8°C. Reconstitution required. Analyte panel: Cyclosporine, Sirolimus, Tacrolimus.

Indications for Use

Indicated for use as an assayed quality control material to monitor the precision of laboratory testing procedures for immunosuppressant analytes (Sirolimus, Tacrolimus, 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.

Predicate Devices

• Lyphochek Whole Blood Control (K022041)

Submission Summary (Full Text)

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## Bio-Rad Laboratories Whole Blood Immunosuppressant Controls Summary of Safety and Effectiveness

KO7272|

#### 1.0 Submitter

Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: [phone] [phone] Fax:

### Contact Person

DEC 1 1 2007

Suzanne S. Parsons Regulatory Affairs Specialist Telephone: [phone]

## Date of Summary Preparation

September 13, 2007

#### 2.0 Device Identification

| Product Name: | - Lyphochek Whole Blood Immunosuppressant Control<br>- Abbott Immunosuppressant MCC |
|---------------|-------------------------------------------------------------------------------------|
| Common Name: | Drug mixture control materials<br>Clinical toxicology control material. |

Classification: Product Code: Regulation Number:

Class I DIF 21 CFR 862.3280

#### 3.0 Device to Which Substantial Equivalence is Claimed

Lyphochek Whole Blood Control Bio-Rad Laboratories Irvine, California 92618

510 (k) Number: K022041

#### 4.0 Description of Device

Lyphochek Whole Blood Immunosuppressant Controls and Abbott Immunosuppressant MCC are both prepared from human whole blood, with added chemicals, and stabilizers.

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#### 5.0 Intended Use

Lyphochek Whole Blood Immunosuppressant Controls or Abbott Immunosuppressant MCC is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

#### 1.0 Comparison of the new device with the Predicate Device

Whole Blood Immunosuppressant Controls claim substantial equivalence to the Lyphochek Whole Blood Control currently in commercial distribution (K022041).

| Characteristics | Bio-Rad<br>Lyphochek Whole Blood Immunosuppressant Controls<br>Abbott Immunosuppressant MCC<br>(New Device) | Bio-Rad<br>Lyphochek Whole Blood Control<br>(Predicate Device K022041) |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Lyphochek Whole Blood Immunosuppressant Control or Abbott<br>Immunosuppressant-MCC is intended for use as an assayed<br>quality control serum to monitor the precision of laboratory testing<br>procedures for the analytes listed in the package insert. | Lyphochek Whole Blood Control is<br>intended for use as an assayed quality<br>control serum to monitor the precision<br>of laboratory testing procedures for the<br>analytes listed in the package insert. |
| Form | Lyophilized | Lyophilized |
| Storage (Unopened) | 2-8°C until expiration date | 2-8°C until expiration date |
| Open vial after<br>Reconstitution<br>(Refrigerated) | 14 days at 2 to 8°C. | 14 days at 2 to 8°C with the following<br>exceptions: Red cell folate will be stable<br>for 3 days at 2 to 8°C. |
| Open vial after<br>Reconstitution<br>(Frozen) | 30 days at -20 to -70°C. | 30 days at -10 to -20°C. |
| Differences | | |
| Matrix | EDTA Whole blood | Citrated Whole blood |
| Analytes | Cyclosporine<br>Sirolimus<br>Tacrolimus | Cyclosporine<br>Sirolimus<br>Tacrolimus<br><br>Red Cell<br>Folate<br>Lead<br>Serotonin |

Table 1: Similarities and Differences between new and predicate device

#### 6.0 Statement of Supporting Data

Stability studies have been performed to determine the open vial stability and shelf life for this control. Product claims are as follows:

- . Open vial Stability:
- ▶ After reconstituting, all analytes will be stable for 14 days at 2 to 8°C or 30 days at -20 to -70°C.
- . Shelf Life: 3 Years at 2 to 8°C

All supporting data is retained on file at Bio-Rad Laboratories.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is encircled by the words "U.S. Department of Health and Human Services" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

BioRad Laboratories Inc. Diagnostics Group c/o Ms. Elizabeth Platt 9500 Jeronimo Road Irvine, CA 92618-2017

DEC 1 1 2007

k072721 Re:

Trade/Device Name: Lyphochek Whole Blood Immunosuppressant Control Regulation Number: 21 CFR§862.3280 Regulation Name: Clinical Toxicology Control Material Regulatory Class: Class I, reserved Product Code: DIF Dated: September 21, 2007 Received: September 26, 2007

Dear Ms. Platt:

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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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 1 ogally marketed predicate device results in a classification for your device on thus, perroits 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 &ct from the Division of Small Manufacturers, International and Consumer Assistance at its toll free number [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Yéan M. Cooper, M.S., D.V.M. 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): | K072721 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Lyphochek Whole Blood Immunosuppressant Control |
| Indications For Use: | Lyphochek Whole Blood Immunosuppressant Controls is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. |
| | The following analytes are listed in the package insert: |
| | <ul><li>Sirolimus</li><li>Tacrolimus</li><li>Cyclosporine</li></ul> |
| Device Name: | Abbott Immunosuppressant MCC |

Indications For Use:

Abbott Immunosuppressant MCC is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

The following analytes are listed in the package insert:

- Sirolimus ▲
- Tacrolimus ▶

Prescription Use _ X (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)

| Division Sign-Off | |
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Office of In Vitro Diagnostic Device
Evaluation and Safety

| 510(k) | K072721 |
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