(195 days)
For the quantitative determination of Total Protein in urine and cerebrospinal fluid (CSF). For IN VITRO diagnostic use.
Total Protein (Micro) Assay
The provided text is an FDA 510(k) clearance letter for the "Total Protein (Micro) Assay" device. It does not contain information about acceptance criteria, device performance, specific study details, or ground truth establishment.
The letter confirms that the device is substantially equivalent to a legally marketed predicate device for the quantitative determination of Total Protein in urine and cerebrospinal fluid (CSF) for in vitro diagnostic use. It outlines the regulatory classification, general controls, and other regulatory information but does not include the type of detailed study information requested.
Therefore, I cannot provide the requested table and study details based on the input text.
§ 862.1635 Total protein test system.
(a)
Identification. A total protein test system is a device intended to measure total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.