(20 days)
BUN Reagent is intended for the quantitative determination of urea nitrogen in serum using Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of certain renal and metabolic diseases.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a Blood Urea Nitrogen (BUN) Reagent. This document is a regulatory approval letter for an in vitro diagnostic (IVD) device, not an AI/ML medical device. Therefore, the specific questions regarding acceptance criteria, study details, ground truth, and expert involvement for AI/ML performance evaluation are not applicable to this document.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act)."
This indicates a process of demonstrating substantial equivalence to a predicate device, which relies heavily on comparing the new device's characteristics and performance to an already legally marketed device, often through analytical and clinical performance studies specific to IVDs (e.g., precision, accuracy, linearity, interferences).
Therefore, I cannot provide the requested information as it pertains to AI/ML device evaluation, as this document is not about such a device.
§ 862.1770 Urea nitrogen test system.
(a)
Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.(b)
Classification. Class II.