(114 days)
This Cystatin C kit is intended for the quantitative determination of Cystatin C in human serum, lithium heparin, plasma and EDTA plasma by turbidimetry using the Roche Modular P analyser. Cystatin C measurements in serum and plasma are used as an aid in the diagnosis and treatment of renal diseases in conjunction with other laboratory and clinical findings.
Human Cystatin C kit For Use on the Modular P
The provided document is a 510(k) premarket notification letter from the FDA for a medical device called "Human Cystatin C kit For Use on the Modular P." This document primarily focuses on regulatory approval and does not contain detailed information regarding the acceptance criteria, study design, or performance metrics of the device as requested in the prompt.
Therefore, it is not possible to provide the requested information based solely on the provided text. The document confirms market clearance based on substantial equivalence to a predicate device, but it does not describe the specific studies or performance data used to support that claim beyond what is typically presented in a 510(k) summary (which is not fully included here).
To fulfill the request, a more comprehensive document, such as the 510(k) summary or the full submission, would be required.
§ 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.