(136 days)
The cobas u 411 urine analyzer is a semi-automated, benchtop analyzer which is designed to read the Chemstrip 10 UA (Combur' Test M) test strips for urinalysis for the measurement of bilirubin, blood, glucose, ketone, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen and color (if selected). These measurements are useful in the evaluation of renal, urinary and metabolic disorders. Tests performed using the cobas u411 are intended for prescription, in vitro diagnostic use only.
The cobas u 411 urine analyzer is a semi-automated, benchtop analyzer which is designed to read Chemstrip 10 UA (Combur10 Test M) test strips for urinalysis for the measurement of bilirubin, blood, glucose, ketone, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen and color (if selected). These measurements are useful in the evaluation of renal, urinary and metabolic disorders. Tests performed using the cobas u411 are intended for prescription, in vitro diagnostic use only. The functions of the cobas u 411 analyzer includes: o Sample identification (with optional barcode scanner) o Controlled incubation period o Photometric measurements o Result memory o Optional formats for data output
The provided text is a 510(k) Summary for the cobas u 411 Urinalysis Test System. While it describes the device's intended use, its components, and compares it to a predicate device, it does not contain information about acceptance criteria, specific study designs, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance data.
The document states that the cobas u 411 urinalysis test system is "substantially equivalent to other devices legally marketed in the United States" and claims equivalence to the Chemstrip Urine Analyzer (K921087 and K931602). This implies that the device likely met performance criteria comparable to the predicate device, but the details of those criteria and the specific study proving their achievement are not included in this summary.
Therefore, I cannot provide the requested table or answer the specific questions about the study design, sample sizes, and expert involvement as the information is not present in the provided text.
The text focuses on classifying the device, describing its technology, and comparing its features to an existing, legally marketed device to establish substantial equivalence. It does not delve into the detailed clinical or analytical performance study results that typically include acceptance criteria and their verification.
§ 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.