(35 days)
HiChem Cholesterol Reagent is intended for the quantitative determination of total cholesterol in serum and plasma for the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
The HiChem Cholesterol Reagent determines cholesterol through the enzymatic action of cholesterol esterase, cholesterol oxidase and peroxidase. The resulting increase in absorbance at one of interested estable concessed on concentration in the sample.
Here's an analysis of the acceptance criteria and the studies performed for the HiChem Cholesterol Reagent, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The document describes two scenarios: the HiChem Cholesterol Reagent as a manual procedure and the HiChem Cholesterol Reagent used as a secondary reagent on Beckman® SYNCHRON CX® Systems. The acceptance criteria are largely implied by the reported performance figures, as specific pre-defined thresholds aren't explicitly stated as "acceptance criteria." However, the comparisons to the predicate device and specified ranges (e.g., linearity) serve as the de facto criteria.
Scenario 1: HiChem Cholesterol Reagent (Manual Procedure)
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Linearity | Performance should be linear from 5 mg/dL to 750 mg/dL. | Linear from 5 mg/dL to 750 mg/dL. |
| Regression: (HiChem Recoveries) = 3.7 mg/dL + 0.975 × (Standard Factors), r² = 1.000 Sv.x = 4.11 mg/dL. df = 11 | ||
| Precision (Within-run) | Not explicitly stated, but expected to be low for control sera. | Serum control 1 (109 mg/dL): 0.85 mg/dL |
| Serum control 2 (226 mg/dL): 1.46 mg/dL | ||
| Serum control 3 (501 mg/dL): 3.12 mg/dL | ||
| Precision (Total) | Not explicitly stated, but expected to be low for control sera. | Serum control 1 (109 mg/dL): 0.92 mg/dL |
| Serum control 2 (226 mg/dL): 1.90 mg/dL | ||
| Serum control 3 (501 mg/dL): 4.47 mg/dL | ||
| Method Comparison | Results should be equivalent to the Beckman® Cholesterol Reagent. | (HiChem Results) = 12 mg/dL + 0.957 × (Beckman® Results) |
| r² = 0.966 S(y.x) = 8.1 | ||
| Anticoagulant Interference | Bias due to additives should be minimal. | Bias |
§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(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.