CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS;QALIB

K061182 · Cliniqa Corporation · JJY · May 25, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061182
• Device Name: CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS;QALIB
• Applicant: Cliniqa Corporation
• Product Code: JJY · Clinical Chemistry
• Decision Date: May 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

CLINIQA Liquid QC Lipid Controls Levels 1 and 2 are intended for use as assayed quality control material for Apolipoprotein A-1, Apolipoprotein B, Cholesterol (total), High Density Lipoprotein, Low Density Lipoprotein, and Triglyceride analysis. CLINIQA LiniCAL Lipid Calibration Verifiers Levels A - E for Olympus AU Systems are assayed, liquid, quality control products which may be used to evaluate the performance of the Olympus AU Systems for Cholesterol (total), High Density Lipoprotein, Low Density Lipoprotein, and Triglyceride at five useful concentrations. CLINIQA QALIBRATE - Lipid Calibrator is intended for use in assay method calibration for clinical chemistry analyzers listed in the product insert.

Device Story

CLINIQA Lipid products consist of human serum-based liquid controls, calibration verifiers, and calibrators. These products are used in clinical laboratories to monitor the performance of automated chemistry analyzers and calibrate lipid assays (Apolipoprotein A-1, Apolipoprotein B, Cholesterol, HDL, LDL, Triglycerides). The products are ready-to-use, containing preservatives and stabilizers. Calibration verifiers are specifically designed for Olympus AU systems to assess performance across the reportable range (Levels A-E). Healthcare providers use the output (control/calibration results) to verify the accuracy and precision of patient sample testing, ensuring reliable clinical decision-making regarding lipid management.

Clinical Evidence

No clinical data. Bench testing only. Stability was validated using the Arrhenius model of accelerated elevated temperature studies to predict storage stability at 2-8°C. Value assignment was performed using consensus testing across multiple laboratories with a minimum of 12 data points per lot.

Technological Characteristics

Liquid, assayed, multi-level control and calibration materials. Formulated for specific clinical chemistry analytes (Apolipoprotein A-1, B, Cholesterol, HDL, LDL, Triglycerides). Designed for use with clinical chemistry analyzers (e.g., Olympus AU systems).

Indications for Use

Indicated for use as quality control material and calibrators for lipid-related clinical chemistry assays. Intended for professional use in clinical laboratory settings on automated chemistry analyzers.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's emblem, which is a stylized representation of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the emblem.

## Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## MAY 2 5 2006

Ms. Carol Ruggiero Director of Regulatory Affairs Cliniqa Corporation 1432 South Mission Road Fallbrook, CA 92028

k061182 Re:

> Trade/Device Name: CLINIQA® Liquid QC™ Lipid Controls Levels 1 and 2 CLINIQA® LiniCAL® Lipid Calibration Verifiers Levels A-E for Olympus CLINIQA® QALIBRATE™ - Lipid Calibrator Regulation Number: 21 CFR§ 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JJY, JIX Dated: April 25, 2006 Received: April 27, 2006

Dear Ms. Ruggiero;

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 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,

Alberto G. A.

Alberto Gutierrez, Ph.D. 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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510(k) Number (if known): KOGl (82

Device Name: CLINIQA® Liquid QC™ Lipid Controls Levels 1 and 2

Indications For Use:

CLINIQA Liquid QC Lipid Controls Levels 1 and 2 are intended for use as assayed quality control material for Apolipoprotein A-1, Apolipoprotein B, Cholesterol (total), High Density Lipoprotein, Low Density Lipoprotein and Triglyceride analysis.

510(k) Number (if known):

Device Name: CLINIQA® Lipid Calibration Verifiers Levels A - E for Olympus AU Systems

Indications For Use:

CLINIQA LiniCAL Lipid Calibration Verifiers Levels A - E for Olympus AU Systems are assayed, liquid, quality control products which may be used to evaluate the performance of the Olympus AU Systems for Cholesterol (total), High Density Lipoprotein. Low Density Lipoprotein and Triglyceride at five useful concentrations.

510(k) Number (if known):

Device Name: CLINIQA QALIBRATE™ - Lipid Calibrator

Indications For Use:

CLINIQA QALIBRATE™ - Lipid Calibrator is intended for use in assay method calibration for clinical chemistry analyzers listed in the product insert.

Prescription Use _ X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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