(136 days)
The Randox Laboratories Limited Creatinine Test Kit is an in vitro diagnostic reagent for the quantitative determination of creatinine in human serum and plasma. The method is based on the reaction of creatinine with picrate in an alkaline environment (Jaffe) to produce a coloured complex. Creatinine is measured primarily to assess kidney function.
The Randox Laboratories Limited Creatinine Test Kit is an in vitro diagnostic reagent for the quantitative determination of creatinine in human serum and plasma. The method is based on the reaction of creatinine with picrate in an alkaline environment (Jaffe) to produce a coloured complex.
The provided text is a 510(k) premarket notification letter from the FDA regarding a Creatinine test kit. It acknowledges the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
FDA 510(k) clearance primarily focuses on demonstrating substantial equivalence to a predicate device, not necessarily on presenting a detailed performance study against predefined acceptance criteria in the format requested. While the manufacturer (Randox Laboratories) would have conducted studies to demonstrate the device's performance for their 510(k) submission, the provided FDA letter and enclosed "Indications For Use" statement do not include the specific details about those studies, such as sample size, ground truth establishment, or expert qualifications.
Therefore, I cannot provide the requested information based solely on the text provided. The document confirms the FDA clearance but doesn't detail the underlying performance data and how it met acceptance criteria.
If such information were present in a different document (e.g., the actual 510(k) summary submitted by Randox Laboratories), I would be able to extract it.
§ 862.1225 Creatinine test system.
(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. 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.(b)
Classification. Class II.