CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3

K070741 · Cliniqa Corporation · JJY · May 4, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070741
• Device Name: CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3
• Applicant: Cliniqa Corporation
• Product Code: JJY · Clinical Chemistry
• Decision Date: May 4, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

CLINIQA® Liquid QC™ Assayed is intended for use as an assayed quality control material for the constituents listed in this package insert.

Device Story

CLINIQA Liquid QC Assayed General Chemistry Control is a ready-to-use liquid control material prepared from human serum, purified extracts of human and animal origin, chemicals, and drugs. It is used in clinical laboratories to monitor the performance of various clinical chemistry assays. The product is provided in three levels to cover different concentration ranges. Healthcare professionals use the control by running it alongside patient samples on clinical chemistry analyzers. The output is a measured value for specific analytes, which the laboratory compares against the provided target values to verify the accuracy and precision of their testing systems. This process helps ensure the reliability of patient test results.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Serum-based control material containing human/animal extracts, chemicals, and drugs. Ready-to-use liquid form; no reconstitution required. Includes preservatives and stabilizers. Storage requirements: -20°C unopened; 2-8°C once opened. Standard: CLSI EP6-P (linearity evaluation).

Indications for Use

Indicated for use as an assayed quality control material for general chemistry constituents in clinical laboratory settings.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and service. The eagle is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged around the border of the circle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

MAY - 4 2007

k070741 Re:

Trade Name: Cliniqa Liquid QC Assayed and Unassayed General Chemistry Control Levels 1, 2 & 3 Regulation Number: 21 CFR §862.1660 Quality control material (assayed and unassayed). Regulation Name: Regulatory Class: Class I (Reserved) Product Code: JJY Dated: March 08, 2007 Received: March 16, 2007

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 80.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tollit the [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): KO70 0 74

Device Name: CLINIQA Liquid QC Assayed General Chemistry Control, Levels 1, 2, & 3

Indications For Use:

CLINIQA® Liquid QC™ Assayed General Chemistry Control is intended for use as an assayed quality control material for the contituents listed in this package insert.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 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)

167

vision Sign-Off

office of In Vitro Diagnostic Device ustion and Safety

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