ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM

K992851 · Roche Diagnostics Corp. · JBP · Jan 14, 2000 · Hematology

Device Facts

• Record ID: K992851
• Device Name: ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM
• Applicant: Roche Diagnostics Corp.
• Product Code: JBP · Hematology
• Decision Date: Jan 14, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7140
• Device Class: Class 2

Intended Use

The CoaguChek Pro ACT test cartridge is for the quantitative determination of the activated clotting time of freshly drawn whole blood, using the CoaguChek Pro System. It is intended for health care professional use only.

Device Story

Device measures activated clotting time (ACT) to monitor heparin therapy. Input: 45 µL fresh whole blood sample applied to rigid plastic cartridge. Operation: Blood drawn into reagent chamber via capillary action; mixes with tissue factor and sulfatide reagents; moves along reaction path. Laser optical system monitors blood flow; endpoint detected when blood stops moving due to clot formation. Instrument automatically reads cartridge code for lot-specific calibration. Used at point-of-care by healthcare professionals. Output: Quantitative ACT result displayed on instrument. Clinical utility: Enables rapid heparin dose adjustment during procedures like PTCA, cardiac catheterization, hemodialysis, and ECMO; helps prevent bleeding or thrombosis complications.

Clinical Evidence

Bench testing only. Performance evaluated via precision studies using liquid controls and arterial whole blood. Accuracy compared to Hemochron predicate (N=539, Y=0.953X + 5.3, R=0.883). Hematocrit range verified at 27–54%. Precision (CV) for liquid controls: Level 1 (5.79%), Level 2 (10.34%). Precision for arterial blood: CV 6% or better.

Technological Characteristics

Rigid plastic test cartridge containing tissue factor and sulfatide reagents. Sensing principle: Laser optical flow monitoring. Energy source: Instrument-powered heating and optical detection. Connectivity: Lot-specific code key for electronic calibration. Dimensions: 45 µL sample volume. Software: Embedded firmware for clot detection and lot-specific calibration.

Indications for Use

Indicated for quantitative determination of activated clotting time (ACT) in freshly drawn venous or arterial whole blood. Intended for use by healthcare professionals at the point of care to monitor heparin effectiveness during procedures such as PTCA, cardiac catheterization, hemodialysis, and ECMO. Not for over-the-counter or self-testing.

Regulatory Classification

Identification

An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood.

Predicate Devices

• Hemochron Whole Blood Coagulation System (K832189, K913861, K960749)

Submission Summary (Full Text)

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K992851

# JAN 1 4 2000

510(k) Summary

| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Submitter name, address, contact | Roche Diagnostics Corporation<br>9115 Hague Rd.<br>P.O. Box 50457<br>Indianapolis, IN 46250-0457<br>[phone]<br><br>Contact Person: Luann Ochs<br>Date Prepared: August 23, 1999 |
| 2) Device name | Proprietary name: ACT Test and Controls for the CoaguChek Pro System<br><br>Common name: activated clotting time test<br><br>Classification name: activated whole blood clotting time test |
| 3) Predicate device | We claim substantial equivalence to the International Technidyne Corporation ACT Test and controls for the Hemochron Whole Blood Coagulation System, K832189, K913861, K960749. |

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### 510(k) Summary

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| 4) Device<br>Description | The activated clotting time test is used to measure coagulation by activating<br>the clotting pathway. The ACT test monitors the effectiveness of heparin<br>during several types of medical procedures. Many procedures such as<br>Percutaneous Transluminal Coronary Angioplasty (PTCA), cardiac<br>catheterization, hemodialysis, and Extracorporeal Membrane Oxygenation<br>(ECMO) require the administration of low to moderate heparin doses.<br>Sensitivity to heparin can vary significantly from patient to patient, and lack<br>of adequate control of the heparin dose can lead to either bleeding or<br>thrombosis.<br><br>The ACT test is initiated by inserting a CoaguChek Pro ACT test cartridge<br>into the instrument. The instrument reads a code on the test cartridge to<br>determine test identity and lot number. The test cartridge contains a sample<br>application well, a reagent chamber, and a reaction path. After the instrument<br>heats the test cartridge, a drop of fresh, whole blood is placed on the test<br>cartridge sample application well. Blood is drawn into the reagent chamber<br>by capillary action, where it mixes with the reagent to initiate coagulation.<br>The blood sample moves along the reaction path until a clot forms. The laser<br>optical system detects the clot by monitoring blood flow; endpoint is reached<br>when the blood stops moving. The time from sample application to clot<br>detection is the activated clotting time. The displayed result is equivalent to<br>the ACT result obtained from a commercially available system. Because each<br>newly-manufactured lot is calibrated to an internal reference lot, any lot-to-lot<br>variability between reagents is corrected electronically using information<br>coded on the lot-specific code key. |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5) Intended use | The CoaguChek Pro ACT test is for the quantitative determination of the<br>activated clotting time of freshly drawn whole blood, using the CoaguChek<br>Pro System. |
| 6) Comparison<br>to predicate<br>device | The Roche Diagnostics ACT Test and controls for the CoaguChek Pro<br>System is substantially equivalent to other products in commercial<br>distribution intended for similar use. Most notably it is substantially<br>equivalent to the currently marketed ACT Test and controls for the<br>Hemochron Whole Blood Coagulation System. |

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| Topic | Comment |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Both are intended for the measurement of<br>activated clotting time in whole blood<br>samples. |
| Closed System | Both systems use instrument, reagent<br>carriers, and controls that are intended to be<br>used together. |
| Sample types | Both systems require nonanticoagulated<br>whole blood samples, either venous or<br>arterial. |
| Professional use | Both systems are indicated for use by health<br>care professionals at the point of care, not<br>for over-the-counter or prescription self-<br>testing. |

The CoaguChek Pro ACT Test and Controls is similar to the Hemochron

ACT test and controls in the following items:

Similarities to predicate device

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Roche Diagnostics August 23, 1999

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#### Differences from predicate device

The following table lists the major differences between the CoaguChek Pro ACT Test and Controls and the predicate Hemochron ACT Test and Controls device:

| Topic | Hemochron ACT | CoaguChek Pro ACT |
|------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating principal | Dislocation of a<br>precision aligned<br>magnetic rod by fibrin<br>fibers in the forming<br>clot. | Blood is drawn into the<br>reagent chamber by<br>capillary action, where<br>it mixes with the<br>reagent. The blood<br>sample moves along the<br>reaction path until a<br>clot forms. |
| Detection system | Clot formation detected<br>by a magnetic sensor | A laser optical system<br>detects the clot by<br>monitoring blood flow. |
| Reagent carriers | Test tube containing an<br>activator | Rigid plastic cartridge<br>containing the reagents<br>in a reagent well |
| Sample volume | 2 mL | 45 µL drop of blood |
| ACT based on | Intrinsic pathway | Extrinsic pathway |
| Activator | Kaolin, celite, or glass | Tissue factor + sulfatide |
| Initiation of ACT | Surface activation of<br>Factor XI via Factor<br>XIIa | Tissue factor / Factor<br>VIIa complex |
| Sample/reagent mixing | Mixed manually by<br>agitating the test tube<br>for 10 seconds | Automatic mixing<br>while blood is<br>traversing the reagent<br>well |
| Heparin range | Every level of heparin<br>anticoagulation, from<br>prophylaxis to intensive | 0-3 U/mL |
| Maximal test time | 1,500 seconds | 500 seconds |
| Sensitive to aprotinin | Yes (Celite ACT only) | No |

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The following chart shows a comparison of performance Performance characteristics characteristic claims for the CoaguChek Pro ACT test and the Hemochron ACT test.

| Claim | Hemochron ACT Test<br>(Predicate) | CoaguChek Pro<br>ACT Test |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Mean Normal | 132 seconds (Celite, healthy<br>participants) | 112 seconds<br>1.0 INR |
| Verified Hematocrit<br>Range | Not in product labeling | 27 – 54% |
| Precision with liquid<br>controls | Not in product labeling, our<br>studies gave:<br>Control Mean CV<br>Between-Day<br>Level 1 125.45 sec 12.36%<br>Level 2 261.08 sec 6.15% | Control Mean CV<br>Between-Day<br>Level 1 115.06 sec 5.79%<br>Level 2 401.02 sec 10.34% |
| Precision with blood | Not in product labeling | Using arterial whole blood,<br>duplicate results gave CVs of 6%<br>or better. |
| Accuracy | Not in product labeling | Arterial Whole Blood:<br>CoaguChek Pro vs. Hemochron:<br>N=539<br>Y=0.953X + 5.3<br>R=0.883 |

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Image /page/5/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines, which are meant to represent the human form.

### JAN 1 4 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Luann Ochs Regulatory Program Manager Roche Diagnostics Corporation 9115 Hague Road Indianapolis, Indiana 46250-0457

Re: K992851

> Trade Name: ACT Test and Controls for the CoaguChek® Pro System Regulatory Class: II Product Code: JBP Dated: December 2, 1999 Received: December 3, 1999

Dear Ms. Ochs:

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 legally marketed predicate 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 against 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 action. In addition, FDA may publish further announcements 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 at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

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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510(k) Number (if known): Device Name: ACT Test and Controls for the CoaguChek Pro System Indications for Use:

The CoaguChek Pro ACT test cartridge is for the quantitative determination of the activated clotting time of freshly drawn whole blood, using the CoaguChek Pro System. It is intended for health care professional use only.

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

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Petu E. Madin

(Division Sign-Off)
Division of Clinical Laboratory Devices K992851
510(k) Number.

Prescription Use Y (Per 21 CFR 801.109)

:

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Roche Diagnostics August 23, 1999

CONFIDENTIAL

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