(12 days)
The Urisys 1100 Urine Analyzer is a reflectance photometer designed to automatically read and evaluate the results of Chemstrip 5 OB, Chemstrip 7 and Chemstrip 10 MD urine test strips for various urine analytes: specific gravity, pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin and blood.
The Urisys 1100 Urine Analyzer is a modification of the previously cleared Chemstrip 101. The external housing was made smaller to give it a more modern design look. A new integrated, fast and silent thermal printer with automatic paper feed is being introduced with the Urisys 1100. The test strip transport has been improved by incorporating a new cog wheel drive and improved test strip tray. The measurement head will still contain 6 LEDs, and the LEDs (green and orange) used for measurement purposes will not change. However, the red LED, which is not used as part of the measurement function, is being replaced with a more common LED.
The provided text is a 510(k) summary for the Roche Diagnostics Urisys 1100™ Urine Analyzer, indicating substantial equivalence to a predicate device. It focuses on the device's intended use, technological similarities, and minor modifications, but does not contain information about specific acceptance criteria, study design, or performance metrics used to validate the device's accuracy or effectiveness.
Therefore, I cannot extract the requested information to fill the table and answer the detailed questions about acceptance criteria and the study proving the device meets them. The document primarily addresses the regulatory approval process based on substantial equivalence.
§ 864.6550 Occult blood test.
(a)
Identification. An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)(b)
Classification. Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.