(168 days)
The Poly-Chem 90 Albumin test system is an in vitro diagnostic procedure intended to measure the albumin concentration in human serum on the Poly-Chem 90 analyzer. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
The Poly-Chem 90 BUN test system is an in vitro diagnostic procedure intended to measure urea nitrogen (an end-product of nitrogen metabolism) in human serum on the Poly-Chem 90 analyzer. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
The Poly-Chem 90 Calcium test system is an in vitro diagnostic procedure intended to measure the total calcium level in human serum on the Poly-Chem 90 analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
The Poly-Chem 90 Carbon Dioxide test system is an in vitro diagnostic procedure intended to measure bicarbonate/carbon dioxide in human serum on the Poly-Chem 90 analyzer. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
The Poly-Chem 90 Creatinine test system is an in vitro diagnostic procedure intended to measure creatinine levels in human serum on the Poly-Chem 90 analyzer. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
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This document is a 510(k) clearance letter for an in vitro diagnostic device, the Poly-Chem 90 Albumin, BUN, Calcium, Carbon Dioxide, and Creatinine tests. It is not a study report or clinical trial document. Therefore, it does not contain the specific information requested about acceptance criteria, device performance, study design, or ground truth establishment.
A 510(k) clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, not typically on a new clinical study with acceptance criteria and performance metrics described in detail within the clearance letter itself. The types of studies referenced in your request (e.g., sample size for test set, expert involvement, MRMC studies, standalone performance) are more common for novel or higher-risk devices that require a PMA (Premarket Approval) or for performance studies conducted by the manufacturer that are submitted as part of the 510(k) but not fully detailed in the FDA's clearance summary.
Therefore, I cannot provide the requested information from the provided text. The document primarily confirms that the FDA has reviewed the manufacturer's submission and found the device substantially equivalent to existing devices, allowing it to be marketed.
§ 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.