(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.
§ 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.