COAGUCHEK S SYSTEM, MODEL 2138280

K994349 · Roche Diagnostics Corp. · JPA · Sep 6, 2000 · Hematology

Device Facts

• Record ID: K994349
• Device Name: COAGUCHEK S SYSTEM, MODEL 2138280
• Applicant: Roche Diagnostics Corp.
• Product Code: JPA · Hematology
• Decision Date: Sep 6, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The CoaguChek S System is used for the quantitative determination of prothrombin time (PT) in fresh capillary or venous whole blood by professional health care providers.

Device Story

CoaguChek S System is a point-of-care diagnostic device for professional use; measures prothrombin time (PT) in fresh capillary or venous whole blood. Input: drop of blood applied to a test strip containing reagents and iron particles. Operation: monitor applies an oscillating magnetic field to the test strip; iron particles move within the sample; coagulation causes clot formation, stopping particle movement. Output: PT result displayed on monitor. Healthcare providers use results to monitor patients on oral anticoagulants (e.g., warfarin) to ensure therapeutic range maintenance. Benefits: rapid, accurate PT monitoring in clinical settings.

Clinical Evidence

Bench testing only. Comparison of CoaguChek S vs. predicate CoaguChek System using venous whole blood (N=219 vs N=81). Accuracy correlation (R=0.904). Precision evaluated with controls and blood samples; CVs for capillary blood were 2.2% and venous blood 2.7%. Factor sensitivity (II, V, VII, X), hematocrit range (32-52%), and reportable range (0.6-8.0 INR) are identical to the predicate.

Technological Characteristics

System consists of a monitor and test strips. Principle: "dancing particle" magnetic oscillation. Materials: test strips contain reagents and iron particles. Connectivity: standalone monitor. Power: battery-operated. Software: embedded firmware for timing and result calculation. Calibration: traceable to WHO reference method.

Indications for Use

Indicated for professional healthcare providers to perform quantitative prothrombin time (PT) testing in patients requiring oral anticoagulant monitoring (e.g., warfarin/Coumadin therapy) using fresh capillary or venous whole blood.

Regulatory Classification

Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• CoaguChek System (K930454)

Reference Devices

• MLA700
• MLA1600

Submission Summary (Full Text)

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K994349

SEP - 6 2000

# 510(k) Summary

.

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Submitter<br>name, address,<br>contact | Roche Diagnostics Corporation<br>9115 Hague Rd.<br>P.O. Box 50457<br>Indianapolis, IN 46250-0457<br>[phone] |
| | Contact Person: Jennifer Tribbett<br>Date Prepared: December 23, 1999 |
| 2) Device name | Proprietary name: CoaguChek ® S System<br>Common name: prothrombin time test<br>Classification name: Prothrombin time test |
| 3) Predicate<br>device | We claim substantial equivalence to the Roche Diagnostics Corporation<br>CoaguChek System, K930454. |
| 4) Device<br>Description | The CoaguChek S System is used for the quantitative determination of<br>prothrombin time (PT) in fresh capillary or venous whole blood by<br>professional health care providers. |
| | Blood coagulation is one of the body's protective responses. Blood clots<br>(thrombi) form as a direct response to vessel injury, preventing excessive loss<br>of blood. Certain disease conditions require oral anticoagulants, sometimes<br>known as blood thinners. Warfarin, sometimes known as Coumadin ®, is a<br>commonly used anticoagulant. People on warfarin must be carefully<br>monitored to ensure the anticoagulant level is maintained in the therapeutic<br>range. One method for monitoring the anticoagulant level is by using the<br>one-stage Prothrombin Time (PT) Test. The CoaguChek Test Strip uses a<br>modified version of this method. |
| | The test strip, used as directed with the CoaguChek S monitor, will accurately<br>measure blood PT values. After placing a drop of fresh whole blood on the<br>test strip, the blood is drawn into the reaction chamber and mixed with<br>reagents that cause coagulation to begin. In the test strip, tiny iron particles<br>are mixed with the sample. Alternating magnetic fields cause the iron<br>particles to move within the sample. The endpoint is reached when the blood<br>clot stops the iron particles from moving. The PT result is then displayed by<br>the monitor. |
| 5) Intended use | The CoaguChek S System is used for the quantitative determination of<br>prothrombin time (PT) in fresh capillary or venous whole blood by<br>professional health care providers. |
| 6) Comparison<br>to predicate<br>device | The Roche Diagnostics CoaguChek S System is substantially equivalent to<br>other products in commercial distribution intended for similar use. Most<br>notably, it is substantially equivalent to the currently marketed Roche<br>Diagnostics CoaguChek System (K930454). |
| | Continued on next page |

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Similaritics to predicate device

The CoaguChek S System is similar to the predicate CoaguChek System in the following items:

| Topic | Comment |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Both are intended for quantitative prothrombin time<br>(PT) testing in fresh capillary or venous whole blood. |
| Principle of Operation | Both systems utilize the same “dancing particle”<br>principle of operation. The PT test strip contains<br>reagents and iron particles. Blood mixes with these<br>reagents and particles on the test strip. At the same<br>time, the monitor starts a timer. The iron particles<br>move in response to an oscillating magnetic field.<br>When the blood clots, the particles stop moving. The monitor stops the timer and displays the result. |
| Closed System | Both systems use instrument, reagent strips, and<br>controls that are provided by Roche and are intended<br>to be used together. |
| PT Test Strips and<br>Controls | Both systems use the same PT test strips, liquid<br>controls and electronic quality controls. |
| Quality control<br>procedure | The recommended liquid and electronic quality<br>control frequency is the same for both systems. |
| Specimen collection<br>and preparation<br>instructions | These instructions are the same for both systems. |
| Calibration of results | Both systems are traceable to the WHO reference<br>method. |

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Differences from predicate device

The following table lists the major differences between the CoaguChek S System and the predicate CoaguChek System.

| Topic | CoaguChek System<br>(Predicate) | CoaguChek S System |
|--------------------|----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Monitor<br>Display | Information is stated in text<br>format. | Information is stated in icon<br>format. |
| | For example: "Apply Sample"<br>is displayed to instruct the user<br>to apply a blood sample. | For example: A picture of a<br>test strip and a drop of blood is<br>displayed to instruct the user to<br>apply a blood sample. |
| Size | 8.8 x 5.5 x 2.2 inches<br>223.5 x 139.7 x 55.9 millimeters | 6.82 x 4.90 x 1.75 inches<br>173.2 x 124.5 x 44.5 millimeters |
| Weight | 1.5 lbs. or 0.68 kilograms<br>(Including Batteries) | 1.0 lbs. or 0.454 kilograms<br>(Including Batteries) |
| Memory | 30 test results with time & date | 60 test results with time & date |

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### Strip related performance characteristics

.

Since the PT test strip utilized by the new CoaguChek S system and the Smeet the PT tool strip anness is the same, certain claims related directly to the production of impacted by the introduction of a new monitor. The following strip are not impacted by tte those strip related claims that will remain the same regardless of the monitor type used.

| Claim | CoaguChek System<br>(Predicate) | CoaguChek S System |
|-----------------------|---------------------------------|---------------------------|
| Factor<br>Sensitivity | Factors II, V, VII, and X | Factors II, V, VII, and X |
| Hematocrit<br>Range | 32% - 52% | 32% - 52% |
| Reportable<br>Range | 0.6 - 8.0 INR | 0.6 - 8.0 INR |
| Reagent<br>Stability | 20 months | 20 months |

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#### Performance characteristics

The following chart shows a comparison of performance characteristic claims for the CoaguChek S System and the CoaguChek System.

| Claim | CoaguChek System (Predicate) | CoaguChek S System |
|-------------------------|---------------------------------------------|-----------------------------------------------------|
| Precision with controls | Between-Day<br>Control Mean CV | Between-Day<br>Control Mean CV |
| | Level 1 12.6 sec 3.7% CV | Level 1 14.9 sec 4.4% CV |
| | Level 2 23.2 sec 4.1% CV | Level 2 20.6 sec 5.2% CV |
| Precision with blood | Capillary<br>17.2 sec 2.2% CV | Capillary<br>19.4 sec 2.2% CV |
| | Venous<br>17.6 sec 1.9% CV | Venous<br>19.3 sec 2.7% CV |
| Accuracy | Venous Whole Blood:<br>CoaguChek vs. MLA700 | Venous Whole Blood:<br>CoaguChek S vs. MLA 700/1600 |
| | N=81<br>Y=0.859x + 1.3<br>R=0.985 | N=219<br>Y=0.935x + 0.004<br>R=0.904 |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 a stylized graphic of an abstract human figure, represented by three curved lines that suggest a person in motion or reaching upwards.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Jennifer Tribbett Regulatory Affairs Specialist Roche Diagnostics Corporation 9115 Hague Road PO Box 50457 Indianapolis, Indiana 46250-0457

SEP 6 2000

K994349 Re: Trade Name: CoaguChek S System Regulatory Class: II Product Code: JPA Dated: June 7, 2000 Received: June 8, 2000

Dear Ms. Tribbett:

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 above und we nave assno as a loss and marketed predicate devices marketed in interstate commerce surved in the energians, to renactment date of the Medical Device Amendments, or to devices that provisions in the provisions with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Costions of the Act. The general controls provisions of the Act include requirements for annual provisions of the Frea - Preces, 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 (1 remarker ripproval), in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good A subbaniancers 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 mspotions, are a courage 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

This letter will allow you to begin marketing your device as described in your 510(k) premarket I inis letter will anow you to object maxantial equivalence of your device to a legally marketed noutication. The I Dr I mailig ssification 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 CFF) Part 801 and If you desire specific acrise is. Jagnostic devices), please contact the Office of Compliance at additionally 607.10 for mi ville diagnestions on the promotion and advertising of your device, [phone]. Truditionally, repliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mioritiation on your rosponsibility free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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K994349 510(k) Number (if known):

Device Name: CoaguChek S System

Indications for Use:

The CoaguChek S System is used for the quantitative determination of prothrombin time (PT) in fresh capillary or venous whole blood by professional health care providers.

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

Peter E. Makris

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