(127 days)
The ATAC Creatinine Reagent Kit, the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of creatinine in serum, plasma and urine. Creatinine results are used in the diagnosis and treatment of renal dialysis and as a calculation basis for measuring other urine analytes.
The ATAC PAK Creatinine Reagent Kit is intended for the quantitative determination of creatinine in serum, plasma and urine. Creatinine results are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis and as a calculation basis for measuring other urine analytes. The ATAC PAK Creatinines creatinine through the reaction of creatinine with alkaline picrate. The initial rate of absorbance increase at 510 nm is proportional to the creatinine concentration of the sample.
The provided text describes the ATAC PAK Creatinine Reagent Kit and its performance characteristics. This is a medical device for in vitro diagnostic use, specifically a reagent kit for measuring creatinine levels. The information presented is typical for a 510(k) submission, demonstrating substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of in vitro diagnostic device (reagent kit), regulatory acceptance criteria typically revolve around accuracy, precision, linearity, and stability, often in comparison to a legally marketed predicate device. The document does not explicitly state "acceptance criteria" but rather presents the results of studies designed to demonstrate the device's performance.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Linearity | Creatinine recovery should be linear across the usable range. | Linear from 0.2 to 25 mg/dL. |
| Regression statistics forced through origin: (ATAC Recoveries) = 0.997 x (Standard Value), Sy.x = 0.19 mg/dL. | ||
| Precision | Demonstrated by replicate assay of control serum. (Implicitly, comparable to predicate). | Serum 1 (0.7 mg/dL): Within Run 1SD = 0.05, %CV = 6.9%; Total 1SD = 0.05, %CV = 7.4% |
| Serum 2 (4.1 mg/dL): Within Run 1SD = 0.06, %CV = 1.6%; Total 1SD = 0.10, %CV = 2.5% | ||
| Serum 3 (7.2 mg/dL): Within Run 1SD = 0.18, %CV = 2.5%; Total 1SD = 0.24, %CV = 3.3% | ||
| Urine 1 (3.6 mg/dL): Within Run 1SD = 0.10, %CV = 2.8%; Total 1SD = 0.12, %CV = 3.3% | ||
| Urine 2 (14.8 mg/dL): Within Run 1SD = 0.42, %CV = 2.9%; Total 1SD = 0.60, %CV = 4.0% | ||
| Method Comparison | Results should correlate well with a commercially available method for serum/plasma and urine. | Serum/Plasma: ATAC 8000 = 0.07 mg/dL + 0.956 x Competitive Reagent, r = 0.998 |
| Urine: ATAC 8000 = 0.02 mg/dL + 0.960 x Competitive Reagent, r = 0.998 | ||
| Calibration Stability | Total imprecision of creatinine recoveries over the claimed period should be low. | Total imprecision |
§ 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.