(21 days)
The UriScan Optima II Urine Analyzer is an automated system for use with UriScan Strip. For routine urinalysis through the analysis of blood, bilirubin, urobilinogen, ketones, protein, nitrite, glucose, pH, specific gravity, and leukocytes, as well as the determination of color.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA for a device called "UriScan Optima II Urine Analyzer." It broadly approves the device for marketing and mentions its intended use. However, it does not contain any information regarding acceptance criteria, study details, or performance metrics that would allow me to answer your specific questions.
The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the device was deemed substantially equivalent to existing devices, but the specific studies and acceptance criteria that led to this determination are not included in the provided text.
Therefore, I cannot provide the requested information based on the given input.
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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 (240)276-0484. 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 (800) 638-2041 or (301) 443-6597 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
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§ 862.1340 Urinary glucose (nonquantitative) test system.
(a)
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.(b)
Classification. Class II.