(45 days)
The Cholesterol Profile test system is useful in monitoring LDL, VIDI, and Lp(a)-C cholesterol when present in concentrations HDL. However in some patients Lp(a)-C may not be greater than 2.5 mg/dL. present at concentrations detectable by electrophoresis. Patients at risk include males over the age of 45 years and females over 55 years, those with family history of coronary heart disease, strokes, hypertension or diabetes and those who smoke. Depending on a patient's number of risk factors, treatment can be medication or diet restrictions.
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The provided text is a letter from the FDA regarding the clearance of the "REP® Cholesterol Profile Kit" and does not contain details about acceptance criteria or specific study data proving the device meets them. This type of document typically confirms that a device has been found substantially equivalent to a legally marketed predicate device, rather than providing the detailed performance study results.
Therefore, I cannot extract the requested information based on the input text. The document states that the device is "substantially equivalent" to predicate devices, implying that its performance is considered comparable, but it does not describe the specific studies or acceptance criteria used to establish that equivalence.
§ 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.