PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404

K020831 · Roche Diagnostics Corp. · GJS · Oct 24, 2002 · Hematology

Device Facts

• Record ID: K020831
• Device Name: PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404
• Applicant: Roche Diagnostics Corp.
• Product Code: GJS · Hematology
• Decision Date: Oct 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7750
• Device Class: Class 2

Intended Use

The CoaguChek S System is intended for quantitative Prothombin Time (PT) testing for monitoring of warfarin therapy, using fresh capillary or non-anticoagulated venous whole blood by professional health care providers.

Device Story

Device consists of PT•S test strips used with CoaguChek S monitor; intended for professional use in clinical settings. Input: drop of fresh capillary or non-anticoagulated venous whole blood. Principle: blood drawn into reaction chamber, mixed with reagents containing iron particles; alternating magnetic fields applied; endpoint detected when blood clot immobilizes iron particles. Output: quantitative PT result displayed on monitor. Healthcare providers use results to monitor warfarin therapy and adjust anticoagulant levels. Benefits: accurate, point-of-care monitoring of blood coagulation status.

Clinical Evidence

Clinical performance evaluated via comparison to laboratory plasma PT methods (Ortho Recombiplastin on MLA 900 analyzer). Accuracy study: 506 venous samples (correlation 0.975) and 294 capillary samples (correlation 0.969). Precision assessed using liquid controls and whole blood samples; total CV for controls ranged from 4.57% to 5.76%. Hematocrit range 32-52% and heparin concentrations up to 2.0 U/mL showed no significant effect on results.

Technological Characteristics

Test strips utilize iron particles for magnetic detection of clot formation. Reagents include sensitive recombinant thromboplastin (ISI ~1.0). System is a point-of-care monitor. Connectivity and software details not specified. Sterilization method not specified.

Indications for Use

Indicated for professional healthcare providers to perform quantitative prothrombin time (PT) testing for monitoring warfarin therapy in patients using fresh capillary or non-anticoagulated venous whole blood.

Regulatory Classification

Identification

A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).

Predicate Devices

• International Technidyne Corporation's (ITC) ProTime Microcoagulation System- ProTime 3 Cuvette (K010599)

Submission Summary (Full Text)

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| 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 |
| | Contact Person: Jennifer Tribbett |
| | Date Prepared: October 22, 2002 |
| 2) Device name | Proprietary name: PT•S Test Strips and Controls for the CoaguChek S System |
| | Common name: Prothrombin time test |
| | Classification name: Prothrombin time test |
| 3) Predicate device | We claim substantial equivalence to International Technidyne Corporation's (ITC) ProTime Microcoagulation System- ProTime 3 Cuvette (K010599) |
| | Continued on next page |

## OCT 2 4 2002

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1020831/

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### 510(k) Summary Continued

The PT•S test strip is intended for quantitative prothrombin time (PT) testing 4) Device for monitoring of warfarin therapy, using fresh capillary or non-Description anticoagulated venous whole blood with the CoaguChek S System by professional health care providers.

> Blood coagulation is one of the body's protective responses. Blood clots (thrombi) form as a direct response to vessel injury, preventing excessive loss of blood. Certain disease conditions require oral anticoagulants, sometimes known as blood thinners. Warfarin, sometimes known as Cournadin®, is a commonly used anticoagulant. Patients on warfarin must be carefully monitored to ensure the anticoagulant level is maintained in the therapeutic range. One method for monitoring the anticoagulant level is by using the one-stage Prothrombin Time (PT) Test. The PT.S test strip uses a modified version of this method.

> The PT.S test strip, used as directed with the CoaguChek S monitor, will accurately measure blood PT values. After placing a drop of fresh whole blood on the test strip, the blood is drawn into the reaction chamber and mixed with reagents that cause coagulation to begin. In the test strip, tiny iron particles are mixed with the sample. Alternating magnetic fields cause the iron particles to move within the sample. The endpoint is reached when the blood clot stops the iron particles from moving. The PT result is then displayed by the monitor.

- For quantitative prothrombin time (PT) testing for monitoring of warfarin 5) Intended use therapy, using fresh capillary or non-anticoagulated venous whole blood by professional health care providers.
The Roche Diagnostics PT.S test strip and controls for the CoaguChek S 6) Comparison to predicate System are substantially equivalent to other products in commercial device distribution intended for similar use. Most notably, the PT.S test strip and substantially equivalent to International Technidyne controls are Corporation's (ITC) ProTime Microcoagulation System- ProTime 3 Cuvette (K010599).

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### 510(k) Summary Continued

| Similarities to<br>predicate<br>device | The PT-S test strip and controls are similar to the ITC ProTime System in the<br>following items: |
|----------------------------------------|---------------------------------------------------------------------------------------------------|
|----------------------------------------|---------------------------------------------------------------------------------------------------|

| Topic | ProTime Microcoagulation System<br>(K010599)<br>As Indicated in the ProTime Device Insert | PT•S Test Strips For Use With<br>CoaguChek S System |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For the quantitative determination of<br>prothrombin time from fingerstick whole<br>blood or anticoagulant-free venous whole<br>blood. Intended for professional use in<br>the management of patients treated with<br>oral anticoagulants. | For the quantitative prothrombin<br>time (PT) testing for monitoring of<br>warfarin therapy, using fresh<br>capillary or non-anticoagulated<br>venous whole blood by professional<br>health care providers. |
| Test Principle | Measures the PT using fibrin clot<br>formation and detection. | Same |
| Reagents | Sensitive recombinant thromboplastin<br>with an ISI of approximately 1.0. | Same |
| Claim | ProTime Microcoagulation System<br>(K010599)<br>As Indicated in the ProTime Device Insert | PT•S Test Strips For Use With<br>CoaguChek S System |
| Normal Range | Not Indicated in the ProTime Insert. | When the PT•S test was performed<br>using the CoaguChek S monitor on<br>122 normal, healthy, warfarin-free<br>individuals using venous and<br>capillary samples, 99% of the venous<br>and capillary INRs ranged from 0.8<br>to 1.1. |
| Reportable Range | INR range of 0.8 to 7.0 with a calculated INR<br>from 0.8 to 9.9. If INR >7.0, the numerical<br>result is marked with an "*". If INR >9.9 a<br>message indicating this is displayed.<br>NOTE: The ProTime gives a numerical result<br>up to 9.9 INR. | The CoaguChek S System has a PT<br>reportable range of 0.8 - 6.0 INR. |
| Factor Sensitivity | ProTime is sensitive to deficiencies in vitamin<br>K-dependent coagulation factors known to<br>influence the PT test (ie. Factors II, VII and X) | Internal studies were performed<br>utilizing four replicates of each<br>Factor Level (II, V, VII and X).<br>Samples were assayed on the<br>CoaguChek S and Ortho<br>Recombiplastin on the MLA 900<br>Analyzer. Results are shown as<br>graphs in the test strip insert. |
| Hematocrit Range | Hematocrit levels between 20% and 60% do<br>not significantly affect test results. | Hematocrit ranges between 32-52%<br>do not significantly affect test results. |
| Heparin Levels | Results may be affected in patients receiving<br>heparin or who have an abnormal response to<br>heparin. | The results are unaffected by heparin<br>concentrations up to 2.0 U/mL. The<br>PT•S test strip is insensitive to low<br>molecular weight heparins up to 1 IU<br>anti-factor Xa activity/mL. |

The key difference between the PT-S test strip and the ProTime Differences from predicate Microcoagulation System is the location of the Quality Controls. Both device systems offer quality controls that satisfy the same function and requirements. However, the ProTime System utilizes quality controls which are built into the reagent cuvette, where the Roche PT.S test strip utilizes external liquid controls.

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## 510(k) Summary, Continued

The following chart shows a comparison of performance characteristics for the Performance PT.S test strip and the ProTime Microcoagulation System. characteristics

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## 510(k) Summary, Continued

| Claim | ProTime Microcoagulation System (K010599)<br>As Indicated in the ProTime Device Insert | PT-S Test Strips For Use With CoaguChek S System | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Precision with controls | Precision testing was conducted with two levels of standard control plasma substrate preparations.<br><br>Standard ProTime cuvette:<br>N mean SD Level I within day 17 0.9 0.06 day to day 4/day 1.0 0.08 Level III within day 19 3.2 0.19 day to day 4/day 3.2 0.12 ProTime 3 cuvette: N mean SD Level I within day 18 0.9 0.07 day to day 4/day 0.9 0.12 Level III within day 20 4.0 0.19 day to day 4/day 4.2 0.22 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | The monitor-to-monitor, lot-to-lot and strip-to-strip variability was assessed during internal studies which used two levels of liquid controls, with three test strip lots across nine CoaguChek S monitors. The following data was obtained:<br><br>Level 1 Mean INR 1.2<br>SD %CV Lot to Lot 0.03 2.49 Monitor to monitor 0.01 0.61 Strip to strip 0.05 3.79 Total 0.06 4.57 Level 2 Mean INR 3.0<br>SD %CV Lot to Lot 0.07 2.35 Monitor to monitor 0.03 1.17 Strip to strip 0.15 5.13 Total 0.17 5.76 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Precision with blood | Not Indicated in the ProTime Insert. | Whole blood precision for venous samples was determined from sample duplicates at three external sites. Whole blood capillary data was collected from sample duplicates at two external sites.<br><br>Bland Altman plots for both capillary and venous blood are provided in the test strip insert | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

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# 510(k) Summary, Continued

| Claim | | ProTime Microcoagulation System<br>(K010599)<br>As Indicated in the ProTime Device Insert | PT•S Test Strips For Use With<br>CoaguChek S System |
|----------|-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Accuracy | | INR results generated by the ProTime and<br>ProTime 3 cuvettes using venous and fingerstick<br>whole blood samples were compared to INR<br>values obtained using standard Laboratory Plasma<br>PT Methods with samples collected in 3.2%<br>sodium citrate tubes. The following accuracy data<br>were obtained.<br><br>Standard ProTime cuvette vs Lab (Plasma) | 506 venous samples were collected<br>from 255 outpatients at three external<br>sites. The INR of each sample was<br>compared to the INR of a venous<br>plasma sample measured on an MLA<br>900 analyzer, using Ortho<br>Recombiplastin. A scatterplot graph is<br>provided in the test strip insert. The<br>results are as follows: |
| | | Regression equation | |
| | Fingerstick | y=0.94x + 0.38 | |
| | Venous | y=0.91x + 0.44 | |
| | | r | y = 1.049x - 0.08 |
| | | 0.95 | Slp Cl (1.028, 1.070) |
| | | 0.94 | Int Cl (-0.13, -0.03) |
| | | n | Correlation = 0.975 |
| | | 229 | |
| | | 232 | |
| | | ProTime 3 cuvette vs Lab (Plasma): | 294 capillary samples were collected<br>from 147 outpatients at two external<br>sites. Capillary blood samples were<br>assayed on the CoaguChek S monitor<br>with the PT•S test strips and venous<br>plasma samples were measured on an<br>MLA 900 analyzer with Ortho<br>Recombiplastin. A scatterplot graph is<br>provided in the test strip insert. The<br>results are as follows: |
| | | Regression equation | |
| | Fingerstick | y=1.05x + 0.07 | |
| | Venous | y=0.97x + 0.19 | |
| | | r | y = 1.048x - 0.10 |
| | | 0.95 | Slp Cl (1.017, 1.079) |
| | | 0.95 | Int Cl (-0.17, -0.02) |
| | | n | Correlation = 0.969 |
| | | 229 | |
| | | 219 | |

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Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract image of an eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SOT 2 4 2002

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

Re: k020831

Trade/Device Name: PT.S Test Strips and Controls for the CoaguChek™ S System Regulation Number: 21 CFR § 864.7750 Regulation Name: Prothrombin Time Test Regulatory Class: II Product Code: GJS, JPA Dated: July 22, 2002 Received: July 23, 2002

Dear Ms. Tribbett:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA mav publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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#### Page 2

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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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): K020831

Device Name: PT.S Test Strips and Controls for the CoaguChek™ S System

#### Indications for Use:

The CoaguChek S System is intended for quantitative Prothombin Time (PT) testing for monitoring of warfarin therapy, using fresh capillary or non-anticoagulated venous whole blood by professional health care providers. :

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Auchin Bautister

Divis n of Clinical Laboratory Device

510(k) Number K020831

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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