(78 days)
The URYXXON® Relax is intended for use as an in vitro diagnostic aid using urine specimens for screening for diabetes metabolic abnormalities, liver diseases, biliary and hepatic obstructions of the kidneys and urinary tract.
The test provided on MACHEREY-NAGEL Reagent strips for the determination of specific gravity, leucocytes, glucose, protein, blood, nitrite, pH, ketones, bilirubin, ascorbic acid and urobilinogen and urine color are considered routine urinalysis.
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I am sorry, but the provided text does not contain the detailed information necessary to complete the table and answer all the questions about acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter for a medical device (UARYXXON) and primarily focuses on its regulatory classification and substantial equivalence to predicate devices, rather than a detailed report of performance studies.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- Information on an MRMC comparative effectiveness study or its effect size.
- Information on a standalone algorithm performance study.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.