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510(k) Data Aggregation
(68 days)
ENA C T™ Assayed Total Cholesterol Controls are intended for exclusive use with the ENA-C.T™ Total Cholesterol Test to monitor the performance of the test at the medical decision points in the determination of elevated cholesterol. The ENA-C-T™ Total Cholesterol Test is an instrumentfree enzymatic assay for the quantitative determination of cholesterol in fingerstick whole blood for use by physicians to screen for elevated cholesterol as a risk factor in coronary heart disease (CHD).
The ENA·C·T™ Assayed Total Cholesterol Controls are ready to use polymer solutions containing cholesterol from non-human (bovine) plasma. There are two levels of control included with each set: Level I is approximately 200 mg/dL and Level II is approximately 240 mg/dL. Assay range values for the ENA·C·T™ Assayed Total Cholesterol Controls are determined by testing the materials on multi-lot ENA·C·T™ Total Cholesterol devices which have been calibrated to produce results correlating to the Abell-Kendall reference method and are thus, traceable to the National Reference System for Cholesterol (NRS/CHOL). The controls are intended for exclusive use with the ENA·C·T™ Total Cholesterol Test.
The controls are used to ensure proper performance of the ENA·C·T™ Total Cholesterol Test and are tested in the same manner as a patient sample. Sufficient volume of the control is added to the ENA C TM Total Cholesterol Test device in the sample well. A self-actuating siphon, in turn, transfers the control to an absorbent pad located immediately below the "START" window. The control-saturated pad shows through the clear window as a yellow indicator, signaling that enough volume has been added and that the analytical process has been initiated. The control solution 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 control solution to permit completion of the enzymatic reactions. Subsequently, the control solution flows into the measurement zone where colorless dyes and the enzyme peroxidase are immobilized on a thin fabric layer.
The hydrogen peroxide generated from the cholesterol in the control solution converts the colorless dyes into a blue color bar, the length of which is proportional to the amount of hydrogen peroxide, and in turn, cholesterol in the control. The bar grows until a precise amount of solution has completely filled the measurement zone and "End/Q. A." draw zone. This draw zone turns green at the end of the procedure when the cholesterol converting enzymes dissolved in the solution 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. Results outside the linear measurement range of the ENA·C·T™ Total Cholesterol Test cannot be reported since the printed scale on the device only covers the range between 120 and 360 mg/dL. The color formed is stable and may be read at any time within 48 hours.
Acceptance Criteria and Device Performance Study for ENA·C·T™ Assayed Total Cholesterol Controls
This document describes the acceptance criteria and the study that demonstrates the performance of the ENA·C·T™ Assayed Total Cholesterol Controls, based on the provided 510(k) summary.
1. Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for the control materials themselves. Instead, the performance is described in terms of their intended use with the ENA·C·T™ Total Cholesterol Test, which is calibrated to the Abell-Kendall reference method and traceable to the National Reference System for Cholesterol (NRS/CHOL).
The key performance described relates to the determination of assay range values for the controls and their ability to monitor the performance of the ENA·C·T™ Total Cholesterol Test.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| I. Control Levels Representative of Medical Decision Points: | Level I is approximately 200 mg/dL and Level II is approximately 240 mg/dL. These levels are explicitly stated to be "at the medical decision points in the determination of elevated cholesterol," indicating they fulfill this criterion. |
| II. Controls Provide Reliable Assay Range Values: | "Assay range values for the ENA·C·T™ Assayed Total Cholesterol Controls are determined by testing the materials on multi-lot ENA·C·T™ Total Cholesterol devices which have been calibrated to produce results correlating to the Abell-Kendall reference method and are thus, traceable to the National Reference System for Cholesterol (NRS/CHOL)." This indicates a robust process for establishing the expected range of results when the controls are used. |
| III. Controls Ensure Proper Performance of the Test: | "The controls are used to ensure proper performance of the ENA·C·T™ Total Cholesterol Test and are tested in the same manner as a patient sample." The detailed description of the assay mechanism (color change, timing, green "End/Q.A." draw zone) implies that abnormal results from the controls would signal a malfunction of the test device or reagents. |
| IV. Controls are Substantially Equivalent to Predicate Device: | "The ENA·C·T™ Assayed Total Cholesterol Controls are substantially equivalent in design and intended use to other products which are used as controls in total cholesterol test systems. Most notably, it is substantially equivalent to the AccuMeter® Cholesterol Controls, manufactured for ChemTrak Incorporated, Sunnyvale, CA (K905405)." This refers to the overall equivalence claim, which is a regulatory acceptance criterion. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not explicitly state the sample size used for determining the assay range values of the ENA·C·T™ Assayed Total Cholesterol Controls. It mentions "multi-lot ENA·C·T™ Total Cholesterol devices," implying multiple devices from different manufacturing lots were used.
The data provenance is not specified regarding country of origin. The study appears to be prospective in nature, involving active testing of the control materials with the ENA·C·T™ Total Cholesterol Test devices to establish their expected performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The concept of "experts" as in "radiologist with 10 years of experience" is not applicable here. The ground truth for the control materials is derived from their chemical composition and their interaction with the immunoassay system (ENA·C·T™ Total Cholesterol Test). The "ground truth" for cholesterol values is traceable to the Abell-Kendall reference method and the National Reference System for Cholesterol (NRS/CHOL). This is a highly standardized and globally recognized reference method for cholesterol determination, established by expert consensus in clinical chemistry over many years.
4. Adjudication Method
The concept of an "adjudication method" (e.g., 2+1, 3+1) is not applicable in this context. Adjudication methods are typically used in studies involving human interpretation of data where consensus among multiple reviewers is needed to establish ground truth (e.g., pathology slide review, image interpretation). Here, the "ground truth" for control values is based on a definitive chemical reference method (Abell-Kendall) and the performance characteristics of the diagnostic test itself.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as this device is a quality control material and not an interpretive or diagnostic device requiring human reader input or comparison of reader performance. The purpose of the controls is to monitor the performance of an instrument-free enzymatic assay, not to assist human readers in making diagnoses.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The performance described here is inherently "standalone" in the sense that the control material is assayed by the ENA·C·T™ Total Cholesterol Test without human intervention during the analytical process itself. The product is not an algorithm or AI; it is a chemical control material. The "algorithm" is the enzymatic reaction and colorimetric measurement built into the test device. The controls are designed to assess the functionality of this built-in assay process.
7. Type of Ground Truth Used for the Test Set
The ground truth for the control materials' expected cholesterol values is established through two primary mechanisms:
- Reference Method Traceability: The ENA·C·T™ Total Cholesterol Test devices, with which the controls are used, are calibrated to produce results correlating to the Abell-Kendall reference method and are thus, traceable to the National Reference System for Cholesterol (NRS/CHOL).
- Intended Performance: The physical properties and chemical composition of the control materials (polymer solutions containing bovine plasma cholesterol) define their inherent cholesterol levels, which are then verified against the calibrated test system.
8. Sample Size for the Training Set
The concept of a "training set" in the context of machine learning or AI is not applicable to this device. This is a chemical control material, not a software algorithm that is "trained" on data.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" and associated "ground truth" establishment is not applicable to this quality control material.
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