CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2

K081908 · Cliniqa Corporation · JJW · Jan 16, 2009 · Clinical Chemistry

Device Facts

• Record ID: K081908
• Device Name: CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2
• Applicant: Cliniqa Corporation
• Product Code: JJW · Clinical Chemistry
• Decision Date: Jan 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

CLINIQA® Liquid QC™ DipScopics Urinalysis Control is intended for use as an assayed quality control material for various urinalysis reagent strips, qualitative hCG methods as well as confirmatory tests such as Acetest®, Clinitest®, and Ictotest®. This control is also intended to evaluate microscopic examination test procedures.

Device Story

CLINIQA® Liquid QC™ Urinalysis Controls (Levels 1 and 2) are ready-to-use liquid quality control materials; composed of human urine base blended with salts, stabilizers, preservatives, buffers, plant-based materials, and purified human proteins. Designed to mimic clinical urine samples containing specific analytes: Glucose, Bilirubin, Ketones, specific gravity, blood, pH, protein, Urobilinogen, Nitrite, leukocytes, hCG, Microalbumin, Creatinine, Galactose, red blood cells, white blood cells, and crystals. Used by laboratory personnel to verify performance of urinalysis reagent strips, qualitative hCG assays, confirmatory tests (e.g., Acetest, Clinitest, Ictotest), and microscopic examination procedures. Controls are donor-tested for infectious diseases (HBsAg, HIV, HCV). Healthcare providers compare test results obtained using these controls against lot-specific expected values provided in the product insert to ensure analytical accuracy and reliability of patient testing.

Clinical Evidence

No clinical data. Bench testing only. Stability claims supported by Arrhenius model accelerated temperature studies and real-time stability testing (1.5 years closed-vial at 2-8 °C; 90 days open-vial at 2-8 °C or 30 days at 20-25 °C).

Technological Characteristics

Liquid-based quality control material; assayed for urinalysis reagent strips, hCG, and confirmatory tests. Class I (Reserved) device under 21 CFR 862.1660.

Indications for Use

Indicated for use as an assayed quality control material for urinalysis reagent strips, qualitative hCG methods, confirmatory tests, and microscopic examination test procedures in clinical 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 & Human Services. The logo consists of a stylized eagle or bird-like symbol, with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

CLINIQA Corporation c/o Ms Dawn Gast Quality Manager 288 Dıstrıbutıon Street San Marcos, CA 92078

JAN 1 6 2009

Re k081908

> CLINIQA Liquid QC Urinalysis Controls, Levels 1 and 2 Trade Name Regulation Number 21 CFR 862 1660 Regulation Name Quality Control Material (Assayed and Unassayed) Regulatory Class Class I (Reserved) Product Codes JJW Dated September 03, 2008 Received October 29, 2008

Dear Ms Gast

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 undications 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, Insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteratıon

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 (OS) 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/dsma/dsmamaın html

Sincerely yours,

Corg C. He

Courtney C Harper, Ph D Acting Director DIvision of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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## Indication for Use

510(k) Number (if known) K081908

Device Name CLINIQA® Liquid QCTM Urinalysis Controls, Levels 1 and 2

Indication For Use

CLINIQA® Liquid QC™ DipScopics Urinalysis Control is intended for use as an assayed quality control material for various urinalysis reagent strips, qualitative hCG methods as well as confirmatory tests such as Acetest®, Clinitest", and Ictotest This control is also intended to evaluate microscopic examination test procedures

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)

Carol C. Benom

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

510(k) K081908

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