LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)

K121143 · Bio-Rad Laboratories · DIF · May 18, 2012 · Clinical Toxicology

Device Facts

• Record ID: K121143
• Device Name: LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)
• Applicant: Bio-Rad Laboratories
• Product Code: DIF · Clinical Toxicology
• Decision Date: May 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Intended Use

Liquichek Whole Blood Immunosuppressant Control 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

Liquichek Whole Blood Immunosuppressant Control is a liquid, human whole blood-based quality control material containing preservatives and stabilizers. It is designed for use in clinical laboratories to monitor the precision of testing procedures for immunosuppressant drugs (Cyclosporine, Tacrolimus, Sirolimus, Everolimus). The device is provided with mean values for four control levels, derived from replicate analyses. Laboratory personnel use the control to establish their own means and acceptable ranges based on their specific test systems and tolerance limits. By comparing observed results against these established ranges, clinicians and laboratory staff can assess the performance and precision of their analytical methods, ensuring the reliability of patient test results.

Clinical Evidence

Bench testing only. Stability studies were performed to determine open vial stability (10 days for Tacrolimus, 14 days for other analytes at 2-8°C) and shelf life (40 months at -20°C to -70°C).

Technological Characteristics

Human whole blood matrix with added preservatives and stabilizers. Liquid form. Analyte content: Cyclosporine, Tacrolimus, Sirolimus, Everolimus. Storage: -20°C to -70°C. Open vial stability: 10-14 days at 2-8°C.

Indications for Use

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

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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K121143

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## Summary of Safety and Effectiveness Liquichek Whole Blood Immunosuppressant control

MAY 1 8 2012

#### 1.0 Submitter

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

## Contact Person

Suzanne Parsons Regulatory Affairs Manager Telephone: [phone]

## Date of Summary Preparation

May 17, 2012

#### 2.0 Device Identification

Liguichek Whole Blood Immunosuppressant Control Product Trade Name: Drug Mixture Control Materials Common Name: Class I, Reserved Classifications: DIF Product Code: 21 CFR 862.3280 Regulation Number:

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

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

510 (k) Number: K072721

#### Description of Device 4.0

This product is prepared from human whole blood with added preservatives and stabilizers. The control is provided in liquid form for convenience.

Mean values for control levels 1-4 of each analyte, derived from replicate analyses, are listed in the package insert. Each laboratory should establish its own means and acceptable ranges based on their own test system and tolerance limits.

#### 5.0 Intended Use

# Confidential

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Liquichek Whole Blood Immunosuppressant Control 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.

### Comparison of the new device with the Predicate Device 6.0

## Table 1: Similarities and Differences between new and predicate device

| Characteristics | Liquichek Whole Blood<br>Immunosuppressant Control<br>(New Device) | Lyphochek Whole Blood<br>Immunosuppressant Control<br>(Predicate Device, K072721) |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Liquichek Whole Blood<br>Immunosuppressant Control is intended<br>for use as an assayed quality control<br>material to monitor the precision of<br>laboratory testing procedures for the<br>analytes listed in the package insert. | Lyphochek Whole Blood<br>Immunosuppressant Controls are<br>intended for use as an assayed quality<br>control material to monitor the precision<br>of laboratory testing procedures for the<br>analytes listed in the package insert. |
| Matrix | Whole Blood | Whole Blood |
| Open Vial Stability | Tacrolimus : 10 days at 2 to 8 °C<br>All other analytes: 14 days at 2 to 8 °C | 14 days at 2 to 8 °C (reconstituted) |
| Shelf Life Storage & Stability | Until expiration date at -20°C to -70°C | Until expiration date at -20°C to -70°C |
| Differences | | |
| Form | Liquid | Lyophilized |
| Reconstituted & Frozen<br>Stability | No claim | 30 days when stored at -20°C to -70°C |
| Analytes | Contains:<br>Cyclosporine<br>Tacrolimus<br>Sirolimus<br>Everolimus | Contains:<br>Cyclosporine<br>Tacrolimus<br>Sirolimus<br>Does not contain:<br>Everolimus |

#### Statement of Supporting Data 7.0 ·

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

| 7.1 | Open Vial Stability: Tacrolimus will be stable for 10 days at 2 to 8 °C. All other analytes will be stable for 14 days. |
|-----|-------------------------------------------------------------------------------------------------------------------------|
|-----|-------------------------------------------------------------------------------------------------------------------------|

40 months at -20°C to -70° C 7.2 Shelf Life Stability:

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## 8.0 Conclusion

. .

.

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Liquichek Whole Blood Immunosuppressant Control is intended to be used for the same purposes as the predicate device. It has the whole blood matrix and performs similarly as the predicate device.

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

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized caduceus, a staff with two snakes entwined around it, which is a common symbol associated with medicine and healthcare. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

## Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Bio-Rad Laboratories c/o Suzanne Parsons Regulatory Affairs/QA/QC Manager 9500 Jeronimo Road Irvine, CA 92618-2017, USA

MAY 1 8 2012

k121143 Re:

Trade Name: Liquichek Whole Blood Immunosuppressant Control Regulation Number: 21 CFR §862.3280 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I, reserved Product Codes: DIF Dated: April 12, 2012 Received: April 16, 2012

Dear Ms. Parsons:

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 moun that 1 Dr mas mass 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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## Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...

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/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

N

Courtney H. Lias, Ph.D.

Director

Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use Form

510(k) Number (if known): K121143

Device Name:

Liquichek Whole Blood Immunosuppressant Control

Indications for Use:

Liquichek Whole Blood Immunosuppressant Control 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
- Cyclosporine
- Everolimus

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)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(K) K12 11 43

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