(69 days)
The Uritek-720+ Urine Analyzer is intended for use with Teco Urine Reagent Strips for Urinalysis such as URS-10, used in the determination of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity, and leukocytes in urine.
Not Found
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving device performance. The document is a 510(k) clearance letter from the FDA for the Uritek-720+ Urine Analyzer, which primarily states that the device is substantially equivalent to legally marketed predicate devices.
The letter mentions:
- Trade/Device Name: Uritek-720+ Urine Analyzer
- Regulation Number: 21 CFR 862.1340
- Regulation Name: Urinary glucose (non-quantitative) test system
- Product Codes: JIL, JIO, LJX, JRE, CEN, JMT, JIR, JIN, CDM, JJB, KQO
- Indications for Use: The Uritek-720+ Urine Analyzer is intended for use with Teco Urine Reagent Strips for Urinalysis (e.g., URS-10) for the determination of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity, and leukocytes in urine.
However, it does not include:
- A table of acceptance criteria or reported device performance.
- Sample sizes used for test sets or data provenance.
- Number or qualifications of experts for establishing ground truth.
- Adjudication methods.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Results from standalone (algorithm-only) performance studies.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This kind of detailed study information is typically found in the 510(k) submission itself (which is not provided here) or in peer-reviewed publications, not in the FDA clearance letter.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 6 2005
Ms. Stephanie Low FDA Correspondent Teco Diagnostics 1268 N. Lakeview Ave Anaheim, CA 92807
Re: K051526
Trade/Device Name: Uritek-720+Urine Analyzer Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (non-quantitative) test system Regulatory Class: Class II Product Code: JIL, JIO, LJX, JRE, CEN, JMT, JIR, JIN, CDM, JJB, KQO Dated: April 26, 2005 Received: June 8, 2005
Dear Ms. Low:
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, Trug, 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, l'isting 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 De-gister.
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 manufagturing 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,
Carol C. Benam
Carol C. Benson, M.A. Acting 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): K051526.
Device Name: Uritek-720+ Urine Analyzer
Indications For Use:
The Uritek-720+ Urine Analyzer is intended for use with Teco Urine Reagent Strips for Urinalysis such as URS-10, used in the determination of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity, and leukocytes in urine.
Prescription Use (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)
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Office of In Vitro Diagnostic Device Evaluation and __ ety
510(k) K051526
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§ 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.