(186 days)
Eon Cholesterol Reagent is an in vitro diagnostic device intended for the quantitative determination of total cholesterol in human plasma and serum using the Eon 100 Clinical Chemistry Analyser. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
Not Found
This is a 510(k) clearance letter for the Eon Cholesterol Reagent, an in vitro diagnostic device. This type of document typically provides regulatory approval based on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies and acceptance criteria as might be seen for novel or higher-risk devices, especially those involving AI/ML.
Therefore, the specific information requested in the prompt, especially regarding AI/ML aspects like training sets, expert adjudication, MRMC studies, and standalone performance, is not present in the provided document because it describes a chemical reagent, not an AI/ML device.
However, I can extract what is available about performance and acceptance criteria for this specific type of device.
1. A table of acceptance criteria and the reported device performance
For in vitro diagnostic reagents like the Eon Cholesterol Reagent, acceptance criteria typically involve demonstrating analytical performance characteristics (e.g., accuracy, precision, linearity) that are comparable to a legally marketed predicate device. The document states that the device is "substantially equivalent" to predicate devices, implying that its performance meets the regulatory expectations for such a comparison. However, the specific numerical acceptance criteria (e.g., ±X% accuracy, CV
§ 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.