(244 days)
The Uritek-151 Urine Analyzer is intended for use with Teco Urine Reagent Strips for Urinalysis The Offick 19 Print Thialy Lermination of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity, and leukocytes in urine.
Not Found
This document is a 510(k) clearance letter for a medical device (Uritek-151 Urine Analyzer) and does not contain the detailed information required to describe acceptance criteria and a study proving the device meets those criteria. The letter confirms that the device is substantially equivalent to a predicate device and can be marketed, but it does not include the actual study data, acceptance criteria, or performance metrics.
Therefore, I cannot provide the requested information based on the provided text. The document is essentially an FDA approval letter, not a scientific study report.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY - 9 2005
Mr. Tong S. Chiah FDA Coorespondent Teco Diagnostics 1268 North Lakeview Avenue Anaheim, CA 92807
Re: K042421
Trade/Device Name: Uritek-151 Urine Analyzer Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (non-quantitative) test system Regulatory Class: Class II Product Code: JIL, JIO LIX, JRE, CEN, JMT, JIR, JIN, CDM, JJB, KQO Dated: February 25, 2005 Received: March 2, 2005
Dear Mr. Chiah:
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 n may 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 (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,
Jean 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
510(k) Number (if known): K042421
Device Name: Uritek-151 Urine Analyzer
Indications For Use:
The Uritek-151 Urine Analyzer is intended for use with Teco Urine Reagent Strips for Urinalysis The Offick 19 Print Thialy Lermination of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity, and leukocytes in urine.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 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)
vision Sign-Off
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Office of In Vitro Diagnostic
Device Evaluation and Safety
Stork: K04242
§ 862.2900 Automated urinalysis system.
(a)
Identification. An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.