(414 days)
Creatinine Enzymatic Reagent Kit is a device which is intended for measurement of creatinine level in human serum, in vitro diagnostic use only. Test results may provide information regarding the status of kidney function and the diagnosis of renal diseases, and also serve as a component of several calculations for determination of creatinine clearance or glomerular filtration rate (GFR).
Creatinine Enzymatic Reagent Kit is a dual reagent one contains Good's buffer, creatine amidinohydrolase, sarcosine oxidase and ESPMT (3-(N-Ethyl-3methylanilino) propanesulfonic acid sodium salt). Reagent two contains Good's buffer, creatinine amidohydrolase, Peroxidase and 4-aminoantipyrine.
The provided text describes the performance characteristics and acceptance criteria for the Teco Creatinine Enzymatic Reagent Kit, but it does not detail a study involving human readers or AI assistance. The device is a diagnostic test kit, not an AI-powered diagnostic system requiring human interpretation.
Therefore, questions related to human reader performance, AI assistance, multi-reader multi-case studies, and human interpretation of ground truth are not applicable to this document. The information provided focuses solely on the analytical performance of the diagnostic reagent kit.
Here's the breakdown of the information that is applicable from your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list acceptance criteria in a dedicated table, but it presents performance data against established guidelines (CLSI standards) and compares it to a predicate device. The "acceptance criteria" are implied by meeting CLSI standards and demonstrating comparable performance to the predicate.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Teco Creatinine Enzymatic Reagent Kit) |
|---|---|---|
| Intended Use | Quantitative determination of creatinine in human serum | Quantitative determination of creatinine in human serum |
| Specimen | Serum | Serum |
| Methodology | Enzymatic | Enzymatic |
| Linearity (Measuring Range) | Comparable to predicate (0.04 to 5.1 mg/dL for serum) | 0.37 - 5.06 mg/dL |
| Correlation (R²) | High correlation with predicate (R closer to 1.0) | R² = 0.9986 (compared to predicate) |
| Storage | 2-8 °C | 2-8 °C |
| Intra-assay Repeatability | Low CV% (e.g., |
§ 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.