(7 days)
The cassette COBAS INTEGRA Creatinine plus ver.2 (CREP2) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.
The COBAS Integra Creatinine plus ver. 2 Assay is an enzymatic method based on the determination of hydrogen peroxide after conversion of creatinine with the aid of creatininase, creatinase, and sarcosine oxidase. The liberated hydrogen peroxide reacts to form a quinone imine dye, the color intensity of which is directly proportional to the creatinine concentration.
The provided document does not contain information about acceptance criteria or a study proving the device meets them. It's a 510(k) summary for a diagnostic assay, focusing on its substantial equivalence to a predicate device, intended use, and technical specifications, rather than performance studies with acceptance criteria commonly found in AI/ML device submissions.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details. The document primarily establishes the device's technical characteristics and intended use in comparison to an existing product.
§ 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.