CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2

K082107 · Cliniqa Corporation · JJY · Sep 17, 2008 · Clinical Chemistry

Device Facts

• Record ID: K082107
• Device Name: CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2
• Applicant: Cliniqa Corporation
• Product Code: JJY · Clinical Chemistry
• Decision Date: Sep 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

CLINIQA® Liquid QC™ Urine Chemistry Controls, Levels 1 and 2 are intended for use as an assayed quality control material. It is not intended for use as a standard. Assay values for analytes listed in this product insert are provided for both levels.

Device Story

CLINIQA® Liquid QC™ Urine Chemistry Controls are liquid, assayed quality control materials used in clinical laboratories to monitor the performance of urine chemistry test systems. The device consists of two levels of control material, each with established assay values for specific analytes. Laboratory personnel use these controls to verify the accuracy and precision of analytical procedures. By comparing observed results against the provided assay values, clinicians can assess the reliability of patient test results. The device does not serve as a calibration standard.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Liquid, assayed quality control material. Two levels provided. Intended for use with urine chemistry analyzers. No specific materials of construction, energy sources, or software algorithms described.

Indications for Use

Indicated for use as an assayed quality control material for urine chemistry testing. No specific patient population, age, or gender restrictions apply as this is an in vitro diagnostic control product.

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/12 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 7 2008

Climiqa Corporation c/o Ms. Carol Ruggiero Director of Regulatory Affairs/Quality 288 Distribution Street San Marcos, CA 92078

Re: k082107

Trade Name: Cliniqa® Liquid QC™ Urine Chemistry Controls, Levels 1 and 2 Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, reserved Product Code: JJY Dated: July 22, 2008 Received: July 25, 2008

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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

Jéan 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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## Indication for Use

510(k) Number (if known): k082107

Device Name: Device Name: CLINIQA® Liquid QC™ Urine Chemistry Controls, Levels 1 and 2

Indication For Use::

CLINIQA® Liquid QC™ Urine Chemistry Controls, Levels 1 and 2 are intended for use as an assayed quality control material. It is not intended for use as a standard. Assay values for analytes listed in this product insert are provided for both levels.

Prescription Use __ X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Ann Chappo
Division Sign Off

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

510(k) Kokz107