(50 days)
The ATAC Direct LDL Reagent Kit, the ATAC Direct LDL Calibrator and the ATAC 8000 Random Access Chemistry System are intended for the quantitative determination of LDL-cholesterol in serum and plasma. LDL-cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease.
The ATAC Direct LDL Reagent determines LDL-cholesterol through a two step reaction, which specifically consumes non-LDL cholesterol in a series of reactions without producing color. In the second reaction step, the chromogen is added, and a second detergent solubilizes the LDL-cholesterol, allowing it to react with cholesterol oxidase, cholesterol esterase and peroxidase in the reagent to produce a color that is proportional to the amount of LDL-cholesterol in the sample.
Here's a breakdown of the acceptance criteria and the study details for the ATAC Direct LDL Reagent Kit, ATAC Direct LDL Calibrator, and ATAC 8000 Random Access Chemistry System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance (ATAC System) |
|---|---|
| Linearity Range | 5 to 700 mg/dL |
| Linearity (Regression Equation - forced through origin) | (ATAC Recoveries) = 0 mg/dL + 1.023 x (Standard Factors) |
| Precision (Within Run) - Low LDL (Serum 1, ~93 mg/dL) | 1SD = 1.4 mg/dL (1.5% CV) |
| Precision (Within Run) - Medium LDL (Serum 2, ~184 mg/dL) | 1SD = 3.3 mg/dL (1.8% CV) |
| Precision (Within Run) - High LDL (Serum 3, ~555 mg/dL) | 1SD = 11.9 mg/dL (2.2% CV) |
| Precision (Total) - Low LDL (Serum 1, ~93 mg/dL) | 1SD = 2.7 mg/dL (2.9% CV) |
| Precision (Total) - Medium LDL (Serum 2, ~184 mg/dL) | 1SD = 4.9 mg/dL (2.7% CV) |
| Precision (Total) - High LDL (Serum 3, ~555 mg/dL) | 1SD = 19.2 mg/dL (3.5% CV) |
| Correlation with Competitive Reagent (Regression Equation) | ATAC 8000 = -1.7 mg/dL + 1.078 x Competitive Reagent |
| Correlation with Competitive Reagent (Correlation Coefficient) | r = 0.996 |
| Correlation with Competitive Reagent (Range) | 19 - 265 mg/dL |
| Accuracy (Correlation with Beta-Quantification Reference Method - Regression Equation) | ATAC 8000 = -4.2 mg/dL + 1.035 x reference method |
| Accuracy (Correlation with Beta-Quantification Reference Method - Correlation Coefficient) | r = 0.986 |
| Accuracy (Correlation with Beta-Quantification Reference Method - Range) | 59 - 178 mg/dL |
| Detection Limit Claim | 5 mg/dL |
| Observed Detection Limit | 0.73 mg/dL (calculated as 2 SD of 30 replicate within run precision) |
| On-board Reagent Stability | 14 days (total imprecision |
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.