(78 days)
This in vitro method is intended to quantitatively measure HDL Cholesterol in human serum and plasma on the Bayer ADVIA® IMS systems. Measurements of HDL Cholesterol are used in assessing cardiovascular risk.
The Bayer ADV/A IMS Direct HDL Cholesterol (D-HDL) method is for in vitro diagnostic use to measure HDL Cholesterol in human serum and plasma. Such measurements are used in the risk assessment of cardiovascular diseases.
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Here's a breakdown of the acceptance criteria and study information for the Direct HDL Cholesterol Method for ADVIA® Modular System (IMS), based on the provided 510(k) summary:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (ADVIA IMS) |
|---|---|
| Imprecision | |
| Level ~37 mg/dL | Total CV (%) = 3.3 |
| Level ~55 mg/dL | Total CV (%) = 1.9 |
| Level ~83 mg/dL | Total CV (%) = 1.8 |
| Correlation | |
| Regression Slope | 0.986 |
| Intercept | 1.16 |
| R-value | 0.988 |
| Syx (mg/dL) | 2.29 |
| Analytical Range | 7 to 90 mg/dL |
Note: The document does not explicitly state numerical "acceptance criteria" values (e.g., "CV must be
§ 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.