(21 days)
For the Kinetic Quantitative determination of Urea Nitrogen (MUN) in serum. Urea Nitrogen determination is an indicator of liver and kidney functions, such as; Mephritis, Acute Liver Destruction and Urinary Obstruction.
Urea Nitrogen (BUN) Liquid Reagent - Kinetic Method
This document is a 510(k) clearance letter from the FDA for a Urea Nitrogen (BUN) Liquid Reagent Set. It confirms that the device is substantially equivalent to legally marketed predicate devices.
The document does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the context of device performance as typically discussed for AI/ML-driven medical devices. Instead, it focuses on the regulatory clearance process for an in vitro diagnostic reagent set.
Therefore, I cannot provide the requested information for the following reasons:
- No acceptance criteria: The letter itself does not state specific performance acceptance criteria for the reagent set. It refers to the device being "substantially equivalent" to predicate devices, implying that its performance is comparable, but doesn't quantify specific metrics like sensitivity, specificity, or accuracy targets.
- No study details: The letter does not describe any specific study conducted to demonstrate the device's performance against detailed acceptance criteria. It's a regulatory clearance, not a clinical or performance study report.
- Nature of the device: This is a diagnostic reagent set, not an AI/ML-driven device that would typically involve test sets, ground truth derived from experts, MRMC studies, or standalone algorithm performance.
The "study" referenced in the context of this document is the 510(k) submission itself, where the manufacturer provides data (e.g., analytical performance, comparison to predicate) to demonstrate substantial equivalence, but the details of such a study are not included in this FDA clearance letter.
§ 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.