(63 days)
THE Albumin BCG reagent is intended for Invitro diagnostic in the quantitative determination of albumin in serum use or plasme.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to A.P. Total Care, Inc. regarding their "Albumin BCG" reagent. This document is a regulatory approval letter and does not contain the detailed information necessary to answer the questions about acceptance criteria and study design for a device.
The letter confirms the device is substantially equivalent to legally marketed predicate devices and is intended for in vitro diagnostic use in the quantitative determination of albumin in serum or plasma. It mentions general regulatory compliance but does not include any specific performance data, study designs, sample sizes, or expert qualifications.
Therefore, I cannot provide the requested information based on the provided text. To answer these questions, a different type of document, such as a summary of safety and effectiveness, a clinical study report, or the 510(k) submission itself, would be required.
§ 862.1035 Albumin test system.
(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.