ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE)

K981181 · Actimed Laboratories, Inc. · CHH · Aug 3, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981181
• Device Name: ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE)
• Applicant: Actimed Laboratories, Inc.
• Product Code: CHH · Clinical Chemistry
• Decision Date: Aug 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1175
• Device Class: Class 1

Intended Use

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 physician directed use (PDU) by the patient for screening and monitoring cholesterol. In a PDU monitoring application, the patient's physician (or other medical professional under the direction of a physician) initially trains the patient to use the test properly and provides information on the proper interpretation of results and limitations of the test. With the physician directed indication for use, patients on cholesterol lowering therapy can test their own total cholesterol at home and provide the results to their physician or other healthcare organization which works with the physician to maintain compliance on the therapy. In a PDU screening application, a physician (or other medical professional under the direction of a physician) initially trains a group of individuals to use the test properly and provides information on the proper interpretation of results and limitations of the test. The physician directed use version of the ENA.C.T™ Total Cholesterol Test kits are then distributed to the group of individuals who can use the test at home and then communicate their results to the physician or healthcare organization.

Device Story

Device is a non-instrumented, dry-chemistry enzymatic assay for quantitative total cholesterol determination in fingerstick whole blood. Patient applies blood sample to flow device; reaction occurs without external timing or handling. Device features factory-calibrated scale for direct visual readout of results in mg/dL within 15-20 minutes. Built-in controls verify sufficient sample volume, reagent function, and test completion. Used at home by patients under physician direction; patients communicate results to healthcare providers to monitor cholesterol-lowering therapy or screening programs. Benefits include improved patient compliance and convenient monitoring of cholesterol levels outside clinical settings.

Clinical Evidence

Clinical study conducted at three sites with 136 paired fingerstick whole blood and venous samples. Comparison performed against CRMLN serum reference method and ENA-C-T™ (POL) device. Results: correlation coefficient (r) of 0.917 vs. CRMLN and 0.899 vs. POL device. Bias at 200 mg/dL and 240 mg/dL was 2.86% and 2.69%, respectively, meeting the <3% bias recommendation. Precision studies showed average CV of 6.9% across all sites, demonstrating reproducibility in patient hands.

Technological Characteristics

Non-instrumented, dry-chemistry enzymatic assay. Flow device with factory-calibrated scale. Visual readout. Built-in controls for sample volume, reagent function, and test completion. Linear range: 120-360 mg/dL. Standalone device; no connectivity.

Indications for Use

Indicated for patients requiring screening or monitoring of total cholesterol levels. Intended for home use by patients following initial training by a physician or medical professional. Not for use by patients without physician direction.

Regulatory Classification

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.

Predicate Devices

• ActiMed Laboratories, Inc., ENA-C-T™ Total Cholesterol Test (POL) (K960377)
• ChemTrak AccuMeter® Cholesterol Test (K905405)

Submission Summary (Full Text)

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AUG 3 1998

# 198118

#### 510(k) SUMMARY

### ACTIMED LABORATORIES, INC. ENA-C.T™ Total Cholesterol Test Physicians Directed Use

## 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], Ext. 119 Phone: [phone] Facsimile:

Contact Person: same as above

March 27, 1998 Date Prepared:

#### Name of Device and Name/Address of Sponsor

ENA-C-T™ Total Cholesterol Test

ActiMed Laboratories, Inc. 5 Terri Lane Burlington, NJ 08016

#### Classification Name

Cholesterol (total) test system

#### Predicate Device

ActiMed Laboratories, Inc., ENA-C-T™ Total Cholesterol Test (POL) (K960377) and ChemTrak AccuMeter® Cholesterol Test (K905405).

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#### Intended Use and Indications for Use

The ActiMed ENA-C'T™ Total Cholesterol Test is a noninstrumented, enzymatic assay intended for the in vitro quantitative determination of total cholesterol in fingerstick whole blood. It is indicated for physician directed use (PDU) by the patient for screening and monitoring cholesterol.

In a PDU monitoring application, the patient's physician (or other medical professional under the direction of a physician) initially trains the patient to use the test properly and provides information on the proper interpretation of results and limitations of the test. With the physician directed indication for use, patients on cholesterol lowering therapy can test their own total cholesterol at home and provide the results to their physician or other healthcare organization which works with the physician to maintain compliance on the therapy.

In a PDU screening application, a physician (or other medical professional under the direction of a physician) initially trains a group of individuals to use the test properly and provides information on the proper intervretation of results and limitations of the test. The physician directed use version of the ENA C.T™ Total Cholesterol Test kits are then distributed to the group of individuals who can use the test at home and then communicate their results to the physician or healthcare organization.

#### Technological Characteristics and Substantial Equivalence

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 - Physicians Directed Use (PDU) is substantially equivalent to the ENA-C-T™ Total Cholesterol Test (POL) in terms of intended use, design, materials, operational features, and performance. Both devices are based upon an enzymatic reaction that occurs when whole blood is added to dry chemistry reagents embedded in a flow device. Both devices are standardized to the National Reference System for Cholesterol (NRS/CHOL). Results from both devices are read visually within approximately 15-20 minutes of addition of sample to the device. For both

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versions of the ENA.C.T™ Total Cholesterol Test, results in mg/dL are read directly from a lot-specific, factory-calibrated scale printed on the device.

Both the ENA.C.T™ Total Cholesterol Test (PDU) and the ENA.C.T™ Total Cholesterol Test (POL) have built-in controls. Both versions of the ENA·C·T™ Total Cholesterol test have 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.

Performance characteristics generated during analytical and clinical studies on the ENA.C.T™ Total Cholesterol Test (PDU) are comparable to those generated in the same study for the ENA-C T™ Total Cholesterol Test (POL). The linear range of both versions of the ENA-C-T™ Total Cholesterol Test is 120 mg/dL to 360 mg/dL. The recovery of cholesterol in the presence of potentially interfering substances was determined for the ENA.C.T™ device. No interference was found in samples containing up to 10 mg/dL ascorbic acid. 11 mg/dL uric acid, 250 mg/dL of hemoglobin, 850 mg/dL of triglycerides, or 20 mg/dL bilirubin. Acetaminophen interferes at a level of 1 mg/dL. The test is affected by high concentrations of ascorbic acid.

Precision results for these two visually read tests are comparable, with percent coefficients of variation generally less than 6.9% for paired fingerstick whole blood samples.

In clinical studies at three POL sites, ENA-C-T™ Total Cholesterol Test (PDU), ENA C T™ Total Cholesterol Test (POL), and CRMLN results were generated on 136 paired fingerstick whole blood and venous samples. Correlation's between the ENA-CT™ Total Cholesterol Test (PDU) and the CRMLN methods and between the ENAC TTM Total Cholesterol Test (PDU)and the ENA-C T™ Total Cholesterol Test (POL) were acceptable. Thus, the ENA C T™ Total Cholesterol Test (PDU) is substantially equivalent to the ENA-C.T™ Total Cholesterol Test (POL) in terms of performance characteristics, as well as intended use, design, materials, and operational features.

#### Analytical and Clinical Testing

#### Linear Range

Results from NCCLS Linearity Protocol testing and from testing 40 normal and abnormal clinical samples demonstrated that the linear range of the ENA C TTM Total Cholesterol Test is 120 mg/dL to 360 mg/dL.

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K981181

#### Interfering Substances

Studies of the recovery of cholesterol in the presence of potentially interfering substances were carried out. No interference was found in samples containing up to 10 mg/dL ascorbic acid, 11 mg/dL uric acid, 250 mg/dL of hemoglobin, 850 mg/dL of triglycerides, or 20 mg/dL bilirubin. Acetaminophen interferes at a level of 1 mg/dL.

#### Precision

The precision of the devices has been established by using data for the ENA C T™ device from the clinical studies. Precision was determined by obtaining the differences between self test/self read and professional test/professional read devices for each subject at each site. The CVs were 5.2%, 6.7%, and 8.8% for Site 1, 2, and 3 respectively, with an average CV for all sites of 6.9%. These results demonstrate that the visually read ENA-C-T™ Total Cholesterol Test was reproducible in the hands of patients trained in the use of the device.

#### Clinical Studies

A total of 136 paired fingerstick whole blood and venous samples were tested during clinical studies at three POL sites. Fingerstick whole blood samples were assayed at the sites by the ENA.C.T™ Total Cholesterol Test and venous samples were assayed at a Cholesterol Reference Method Network Laboratory (CRMLN) by the Abell-Kendall serum reference method or enzymatic method. For the comparison between the ENA-C-T™ Total Cholesterol Test (PDU) and the CRMLN method, the least squares regression equation for all sites was y = 1.018x + 2.13, with a correlation coefficient of r = 0.917. Bias at 200 mg/dL and at 240 mg/dL was 2.86% and 2.69%, respectively. For the comparison between the ENACT™ Total Cholesterol Test (PDU) and the ENA-C-T™ Total Cholesterol Test (POL), the least squares regression equation for all sites was y = 0.931x + 13.8, with a correlation coefficient of r = 0.899.

Precision studies conducted at three POL sites have demonstrated that the visually read ENA-C-T™ Total Cholesterol Test is reproducible, with an average CV of 6.9% for paired fingerstick whole blood samples from a total of 136 subjects. Clinical studies compared the ENA-C-T™ Total Cholesterol Test (PDU) to the CRMLN serum reference method and the ENA CT™ Total Cholesterol Test (PDU) to the ENA-C-T™ Total Cholesterol Test (POL) on samples from 136 patients. Bias of the ENA-C-T™ device (PDU), compared to the CRMLN serum reference method was 2.86% at the 200 mg/dL level and

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# K 981181

2.69% at the 240 mg/dL for the combined sites. These figures are well within the recommendation of the Laboratory Standardization Panel (LSP) on Blood Cholesterol Measurement that bias not exceed 3%. Correlations between the ENA-C-T™ device (PDU) and the CRMLN Method and between the ENA C T™ device (PDU) and the ENA C T™ device (POL) were within 10%. Thus, the ENA C TTM Total Cholesterol Test (PDU) has demonstrated acceptable precision, bias and accuracy, and has been shown to be substantially equivalent to the ENA.C.Tmm Total Cholesterol Test (POL).

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three interconnected shapes.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 3 1998

Susan McGeehan · Manager - Quality Assurance ActiMed Laboratories, Inc. 5 Terri Lane Burlington, New Jersey 08016

Re : K981181 ENA-C-T™ Total Cholesterol Test Model F 20000, (Physician Directed Use) Regulatory Class: I Product Code: СНН Dated: March 27, 1998 Received: April 1, 1998

Dear Ms. McGeehan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:

Indications for Use:

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 physician directed use (PDU) by the patient for screening and monitoring cholesterol.

In a PDU monitoring application, the patient's physician (or other medical professional under the direction of a physician) initially trains the patient to use the test properly and provides information on the proper interpretation of results and limitations of the test. With the physician directed indication for use, patients on cholesterol lowering therapy can test their own total cholesterol at home and provide the results to their physician or other healthcare organization which works with the physician to maintain compliance on the therapy.

In a PDU screening application, a physician (or other medical professional under the direction of a physician) initially trains a group of individuals to use the test properly and provides information on the proper interpretation of results and limitations of the test. The physician directed use version of the ENA.C.T™ Total Cholesterol Test kits are then distributed to the group of individuals who can use the test at home and then communicate their results to the physician or healthcare organization.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

| | Concurrence of CDRH, Office of Device Evaluation |
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|--|--------------------------------------------------|

(Division Sign-Off)

Division of Clinical Laboratory Devices

| 510(k) Number | k981181 |
|---------------|---------|
|---------------|---------|

| Prescription Use | <div style="display:inline-block;"> <img alt="Tick" src="tick.png"/> </div> | OR | Over-The Counter Use |
|--------------------|-----------------------------------------------------------------------------|----|----------------------|
| Per 21 CFR 801.109 | | | |

(Optional Format 1-2-96)