URISCAN OPTIMA II URINE ANALYZER

K050801 · Yd Diagnostics · JIL · Apr 20, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050801
• Device Name: URISCAN OPTIMA II URINE ANALYZER
• Applicant: Yd Diagnostics
• Product Code: JIL · Clinical Chemistry
• Decision Date: Apr 20, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1340
• Device Class: Class 2

Intended Use

The UriScan Optima II Urine Analyzer is an automated system for use with UriScan for routine urinalysis through the analysis of blood, bilirubin, urobilinggen, ketones, protein, nitrite, glucose, pH, specific gravity, and leukocytes, as well as the determination of color.

Device Story

Uriscan Optima II Urine Analyzer; automated system for urine analysis. Modification adds capability for urine color determination. Device processes urine samples; utilizes optical sensing technology to measure color and other parameters. Operated by clinical laboratory personnel. Output provided to healthcare providers for diagnostic assessment of patient urine samples. Modification verified via design control activities, risk analysis, and validation protocols to ensure fundamental scientific technology remains unchanged from predicate.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Automated urine analyzer; utilizes colorimetric reflectance photometry to measure urine test strips. System is designed for professional clinical use. Connectivity and specific software architecture details are not provided in the source document.

Indications for Use

Indicated for use as a urine analyzer for the determination of urine color and other parameters in clinical settings.

Regulatory Classification

Identification

A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three wavy lines emanating from its body, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

APR 2 0 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

YD Diagnostics c/o Jerri Hoi US Agent Biosys Laboratories, Inc. 707 Foothill Blvd Suite 200 La Canada, CA 91011

Re: k050801

Trade/Device Name: UriScan Optima 11 Urine Analyzer Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (nonquantitative) test system Regulatory Class: Class II Regulatory Olass: Class: Class : JIN, JIR, JJB, JMT, JRE, KQO, LJX Dated: March 22, 2005 Received: March 30, 2005

Dear Jerri Hoi:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for assossion in the 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, de noos mat have been 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 I va may, alores vrovisions 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 n may or bund 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 r rease of actived a determination that your device complies with other requirements of the Act that i Drivatal statutes and regulations administered by other Federal agencies. You must or any I 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) I this lotter will and in you to bogan finding of substantial equivalence of your device to a legally premated 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,

Sean M. Cooper, MS, DUM

Jean M. Cooper, MS, 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

K050801 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: UriScan Optima II Urine Analyzer

Indications For Use:

The UriScan Optima II Urine Analyzer is an automated system for use with UriScan The OnOod Topina Tr of For routine urinalysis through the analysis of blood, bilirubin, urobilinggen, ketones, protein, nitrite, glucose, pH, specific gravity, and leukocytes, as well as the determination of color.

Prescription Use_ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Carol Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K050801

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