(132 days)
The Diazyme Cystatin C Assay is an in-vitro diagnostic test for the quantitative determination of Cystatin C in serum or plasma by latex enhanced immunoturbidimetric method. The measurement of Cystatin C is used as an aid in the diagnosis and treatment of renal disease.
Not Found
The provided document is a 510(k) clearance letter for the Diazyme Cystatin C Assay. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed study information, acceptance criteria, or performance data typically found in a 510(k) summary or the full submission.
Therefore, I cannot provide a complete answer to your request based solely on the provided text. The document confirms the device's purpose as an in-vitro diagnostic test for Cystatin C to aid in the diagnosis and treatment of renal disease, but it lacks the specific performance data you are asking for.
To answer your questions, I would need access to the 510(k) summary (which usually includes performance data) or the full 510(k) submission for K093680.
§ 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.