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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.

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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:

1. A table of acceptance criteria or reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Number or qualifications of experts for establishing ground truth.
4. Adjudication methods.
5. Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
6. Results from standalone (algorithm-only) performance studies.
7. Type of ground truth used.
8. Sample size for the training set.
9. 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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