(97 days)
The ActiMed ENA C.T™ Total Cholesterol Test is a non-instrumented, enzymatic assay intended for the in vitro quantitative determination of total cholesterol in fingerstick whole blood. It is indicated for professional use in settings such as clinical laboratories and physician office laboratories (POLs) to screen for elevated cholesterol as a risk factor in coronary heart disease (CHD).
The ENA-C-T™ Total Cholesterol Test is based on stable, dry chemistry reagents embedded in a flow device with a factory calibrated scale. The device provides a direct visual read-out of test results. It has built-in controls to indicate that a sufficient volume of whole blood has been added as sample, to verify that the reagents are functioning, and to confirm when the test has been completed. The test device is self-actuating, requiring neither timing nor handling between addition of the sample and reading the result.
The ENA.C.T™ Total Cholesterol Test starts when a sufficient amount of whole blood has been introduced into the sample well. A self-actuating siphon, in turn, transfers the blood to an absorbent pad located immediately below the "START" window. The blood saturated pad shows through the clear window as a red indicator, signaling that enough sample has been added and that the analytical process has been initiated. The absorbent pad and a second filter separate red cells from plasma. The plasma subsequently flows into an enzyme pad containing cholesterol esterase and cholesterol oxidase which completely convert cholesterol and cholesterol esters into cholestenone and hydrogen peroxide. A flow delay pad restricts passage of the plasma to permit completion of the enzymatic reactions. Subsequently, the plasma flows into the measurement zone which acts as a capillary. In this zone, colorless dyes and the enzyme peroxidase are immobilized on a thin fabric layer. The hydrogen peroxide converted from cholesterol in the plasma converts the colorless dye layer into a blue color bar, the length of which is proportional to the amount of hydrogen peroxide, and in turn, cholesterol in the sample. The bar extends until a precise amount of plasma has completely filled the measurement zone and "END/QA" draw zone. This draw zone turns green at the end of the procedure when the cholesterol converting enzymes dissolved in the plasma react with control cholesterol contained in the draw zone. The appearance of a green color signals that the test is complete and that reagents were active. The total cholesterol concentration is directly read from the factory calibrated scale on the device. The entire process typically requires 12 to 15 minutes. The color bar formed is stable and may be read at any time within 48 hours.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
ENA·C·T™ Total Cholesterol Test: Acceptance Criteria and Study Details
The provided text details the 510(k) summary for the ENA·C·T™ Total Cholesterol Test, comparing it to the predicate device, the ChemTrak, Inc. AccuMeter® Cholesterol Test (K905405). The primary goal is to demonstrate substantial equivalence to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a dedicated section with specific numerical thresholds. Instead, the document discusses performance in relation to the predicate device and national recommendations (NRS/CHOL, LSP). I've inferred the "acceptance criteria" based on these comparisons and stated recommendations.
| Performance Characteristic | Acceptance Criteria (Inferred from comparisons & recommendations) | Reported ENA·C·T™ Performance |
|---|---|---|
| Linear Range | Comparable to predicate device (125-400 mg/dL) | 120 mg/dL to 360 mg/dL |
| Interfering Substances | No interference comparable to predicate device | No interference: up to 8 mg/dL ascorbic acid, 1 mg/dL acetaminophen, 14 mg/dL bilirubin, 200 mg/dL hemoglobin, 800 mg/dL triglycerides. (Comparable to AccuMeter's reported limits) |
| Precision (CV) | Generally less than 5% for controls at medical decision points (Comparable to predicate device) | Within-run CVs |
§ 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.