ENA-C-T ASSAYED TOTAL CHOLESTEROL CONTROLS

K960378 · Actimed Laboratories, Inc. · JJX · Apr 3, 1996 · Clinical Chemistry

Device Facts

• Record ID: K960378
• Device Name: ENA-C-T ASSAYED TOTAL CHOLESTEROL CONTROLS
• Applicant: Actimed Laboratories, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Apr 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

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 instrument-free 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).

Device Story

ENA-C-T™ Assayed Total Cholesterol Controls are ready-to-use polymer solutions containing bovine-derived cholesterol; provided in two levels (approx. 200 mg/dL and 240 mg/dL). Used by physicians in clinical settings to verify performance of the ENA-C-T™ Total Cholesterol Test. Controls are applied to the test device sample well; a self-actuating siphon transfers the solution to an absorbent pad. Enzymatic reaction (cholesterol esterase/oxidase) converts cholesterol to hydrogen peroxide, which reacts with immobilized dyes to produce a blue color bar proportional to cholesterol concentration. A green indicator signals test completion. Healthcare providers visually compare the color bar length against a factory-calibrated scale on the device to ensure the test system is functioning correctly at medical decision points.

Clinical Evidence

Bench testing only. Assay range values were determined by testing materials on multi-lot ENA-C-T™ Total Cholesterol devices calibrated to the Abell-Kendall reference method, ensuring traceability to the National Reference System for Cholesterol (NRS/CHOL).

Technological Characteristics

Ready-to-use polymer solutions containing bovine plasma-derived cholesterol. Two levels: ~200 mg/dL and ~240 mg/dL. Instrument-free, lateral flow-style enzymatic assay mechanism using cholesterol esterase, cholesterol oxidase, and peroxidase. Colorimetric readout via blue dye bar proportional to cholesterol concentration. Traceable to NRS/CHOL.

Indications for Use

Indicated for use by physicians to monitor the performance of the ENA·C·T™ Total Cholesterol Test, which screens for elevated cholesterol as a risk factor for coronary heart disease (CHD) in patients.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• ChemTrak, Inc. AccuMeter® Cholesterol Controls (K905405)

Submission Summary (Full Text)

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K960378
U960378
APT. - 3

# 510(k) SUMMARY

## ACTIMED LABORATORIES, INC.
### ENA-C-T™ Assayed Total Cholesterol Controls

**Submitter’s Name, Address, Telephone Number, Contact Person and Date Prepared**

Susan McGeehan
Manager, Quality Assurance
ActiMed Laboratories, Inc.
5 Terri Lane
Burlington, NJ 08016
Phone: [phone], Ext. 119
Facsimile: [phone]

Contact Person: same as above
Date Prepared: January 25, 1996

**Name of Device and Name/Address of Sponsor**

ENA-C-T™ Assayed Total Cholesterol Controls
ActiMed Laboratories, Inc.
5 Terri Lane
Burlington, NJ 08016

**Classification Name**

Quality Control Material

**Predicate Device**

ChemTrak, Inc. AccuMeter® Cholesterol Controls (K905405)

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V. 466.378

# Intended Use and Indications for Use

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 instrument-free 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).

# Technological Characteristics and Substantial Equivalence

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·T™ 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

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U400375

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 $ENA\cdot C\cdot T^{TM}$ Total Cholesterol Test cannot be reported since the printed scale on the device only covers the range between 120 and $360~\mathrm{mg/dL}$. The color formed is stable and may be read at any time within 48 hours.

The $ENA\cdot C\cdot T^{TM}$ 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.

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