(49 days)
The Foresight™ U120 Urine Analyzer is intended for use in conjunction with the Foresight Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, pH, Blood, Protein, Urobilinogen, Leukocytes and Ascorbic Acid as well as the qualitative detection of Nitrite. The instrument is intended for professional, in vitro diagnostic use only. The measurement can be used in general evaluation of health, and aids in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function, endocrine disorders and diseases or disorders of the urinary tract.
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This is an FDA 510(k) clearance letter for the Foresight U120 Urine Analyzer. It confirms that the device is substantially equivalent to a legally marketed predicate device. The letter also includes the Indications for Use form. However, it does not contain the detailed study information required to answer your questions about acceptance criteria or device performance.
Therefore, I cannot provide the information requested in points 1-9 based on the provided text. This document is a regulatory approval, not a performance study report.
§ 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.