PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422
Device Facts
| Record ID | K021190 |
|---|---|
| Device Name | PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422 |
| Applicant | Roche Diagnostics Corp. |
| Product Code | GJS · Hematology |
| Decision Date | Oct 25, 2002 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7750 |
| Device Class | Class 2 |
Intended Use
For quantitative Prothrombin Time (PT) testing for monitoring of warfarin therapy, using fresh capillary or non-anticoagulated venous whole blood by professional healthcare providers.
Device Story
PT•S test strips used with CoaguChek monitor; measures prothrombin time (PT) for warfarin therapy monitoring. Input: fresh capillary or non-anticoagulated venous whole blood. Operation: blood drawn into reaction chamber; mixed with reagents and iron particles; alternating magnetic fields applied. Endpoint: blood clot stops iron particle movement. Output: quantitative PT result displayed on monitor. Used by professional healthcare providers in clinical settings. Output informs warfarin dosage adjustments to maintain therapeutic range, benefiting patients by preventing excessive bleeding or thrombosis.
Clinical Evidence
Bench testing and clinical comparison studies performed. Precision assessed via monitor-to-monitor, lot-to-lot, and strip-to-strip variability using liquid controls. Accuracy evaluated by comparing 610 venous samples and 448 capillary samples against laboratory plasma PT methods (MLA 900 Analyzer with Ortho Recombiplastin). Correlation coefficients were 0.961 for venous and 0.958 for capillary samples. Hematocrit range (32-52%) and heparin sensitivity (up to 2.0 U/mL) were validated.
Technological Characteristics
Test strip contains reagents and iron particles for magnetic field-based clot detection. Dimensions/form factor: disposable test strip for use with CoaguChek monitor. Energy source: monitor-driven alternating magnetic fields. Connectivity: standalone monitor. Software: embedded firmware for signal processing and result calculation.
Indications for Use
Indicated for professional healthcare providers to monitor warfarin therapy in patients requiring anticoagulation, 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
- ProTime Microcoagulation System- ProTime 3 Cuvette (K010599)
Related Devices
- K020831 — PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404 · Roche Diagnostics Corp. · Oct 24, 2002
- K994349 — COAGUCHEK S SYSTEM, MODEL 2138280 · Roche Diagnostics Corp. · Sep 6, 2000
- K030845 — COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING · Roche Diagnostics Corp. · May 22, 2003
- K110212 — INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP · Alere San Diego, Inc (Formally Biosite Incorporate · May 1, 2012
- K060978 — COAGUCHEK XS SYSTEM · Roche Diagnostics · Aug 11, 2006
Submission Summary (Full Text)
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K021190
| 510(k) Summary | OCT 25 2002 |
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| 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. |
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| 1) Submitter name, address, contact | Roche Diagnostics Corporation 9115 Hague Rd. P.O. Box 50457 Indianapolis, IN 46250-0457 Contact Person: Jennifer Tribbett Date Prepared: October 21, 2002 |
| 2) Device name | Proprietary name: PT•S Test Strips and Controls for the CoaguChek 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) |
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| 4) Device<br>Description | The PT•S test strip is intended for quantitative prothrombin time (PT) testing<br>for monitoring of warfarin therapy, using fresh capillary or non-<br>anticoagulated venous whole blood with the CoaguChek System by<br>professional health care providers. | |
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| | 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. Patients 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 PT•S test strip uses a modified<br>version of this method. | |
| | The PT•S test strip, used as directed with the CoaguChek monitor, will<br>accurately measure blood PT values. After placing a drop of fresh whole<br>blood on the test strip, the blood is drawn into the reaction chamber and<br>mixed with reagents that cause coagulation to begin. In the test strip, tiny<br>iron particles are mixed with the sample. Alternating magnetic fields cause<br>the iron particles to move within the sample. The endpoint is reached when<br>the blood clot stops the iron particles from moving. The PT result is then<br>displayed by the monitor. | |
| 5) Intended use | For quantitative Prothrombin Time (PT) testing for monitoring of warfarin<br>therapy, using fresh capillary or non-anticoagulated venous whole blood by<br>professional health care providers. | |
| 6) Comparison<br>to predicate<br>device | The Roche Diagnostics PT•S test strip and controls for the CoaguChek<br>System are substantially equivalent to other products in commercial<br>distribution intended for similar use. Most notably, the PT•S test strip and<br>controls are substantially equivalent to International Technidyne<br>Corporation's (ITC) ProTime Microcoagulation System- ProTime 3 Cuvette<br>(K010599). | |
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| 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 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 System |
| Normal Range | Not Indicated in the ProTime Insert. | When the PT•S test was performed<br>using the CoaguChek monitor on 122<br>normal, healthy, warfarin-free<br>individuals using venous and capillary<br>samples, 99% of the venous and<br>capillary INRs ranged from 0.8 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<br>result up to 9.9 INR. | The CoaguChek System has a PT<br>reportable range of 0.8 - 8.0 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 Factor<br>Level (II, V, VII and X). Samples<br>were assayed on the CoaguChek and<br>Ortho Recombiplastin on the MLA<br>900 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. |
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Differences The key difference between the PT.S test strip and the ProTime Microcoagulation System is the location of the Quality Controls. Both from predicate 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 Diagnostics PT.S test strip utilizes external liquid controls.
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Performance characteristics
The following chart shows a comparison of performance characteristics for the PT.S test strip and the ProTime Microcoagulation System.
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| Claim | ProTime Microcoagulation System<br>(K010599)<br>As Indicated in the ProTime Device Insert | | | PT•S Test Strips For Use With<br>CoaguChek System | | | | | |
|----------------------------|-------------------------------------------------------------------------------------------------------|---------------------------|-------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|--|
| Precision with<br>controls | Precision testing was conducted with two levels of<br>standard control plasma substrate preparations. | | | The monitor-to-monitor, lot-to-lot and<br>strip-to-strip variability was assessed<br>during internal studies which used two<br>levels of liquid controls, with three test<br>strip lots across nine CoaguChek<br>monitors. The following data was<br>obtained: | | | | | |
| | | Standard ProTime cuvette: | N | mean | SD | | | | |
| | Level I | within day | 17 | 0.9 | 0.06 | Level 1 | | | |
| | | day to day | 4/day | 1.0 | 0.08 | | | | |
| | Level III | within day | 19 | 3.2 | 0.19 | | Mean INR 1.3 | | |
| | | day to day | 4/day | 3.2 | 0.12 | | SD | %CV | |
| | | ProTime 3 cuvette: | N | mean | SD | Lot to Lot<br>Monitor to monitor<br>Strip to strip<br>Total | 0.02<br>0.01<br>0.04<br>0.05 | 1.72<br>0.95<br>3.32<br>3.86 | |
| | Level I | within day | 18 | 0.9 | 0.07 | Level 2 | | | |
| | | day to day | 4/day | 0.9 | 0.12 | | | | |
| | | | | | | Mean INR 3.4 | | | |
| | | | | | | | SD | %CV | |
| | Level III | within day | 20 | 4.0 | 0.19 | Lot to Lot | 0.05 | 1.33 | |
| | | day to day | 4/day | 4.2 | 0.22 | Monitor to monitor<br>Strip to strip<br>Total | 0.08<br>0.13<br>0.16 | 2.22<br>3.79<br>4.59 | |
| Precision with<br>blood | Not Indicated in the ProTime Insert. | | | | | | Whole blood precision for venous<br>samples was determined from sample<br>duplicates at four external sites.<br>Whole blood capillary data was<br>collected from sample duplicates at<br>three external sites.<br>Bland Altman plots for both capillary<br>and venous blood are provided in the<br>test strip insert. | | |
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| Claim | ProTime Microcoagulation System<br>(K010599)<br>As Indicated in the ProTime Device Insert | | PT•S Test Strips For Use With<br>CoaguChek System | |
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| 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. | | 610 venous samples were collected<br>from 309 outpatients at four 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:<br>$y = 1.065x - 0.12$<br>Slp Cl (1.041, 1.090)<br>Int Cl (-0.19, -0.06)<br>Correlation = 0.961 | |
| | Standard ProTime cuvette vs Lab (Plasma):<br>Regression equation | r | n | |
| | Fingerstick<br>Venous | $y=0.94x + 0.38$<br>$y=0.91x + 0.44$ | 0.95<br>0.94 | 229<br>232 |
| | ProTime 3 cuvette vs Lab (Plasma):<br>Regression equation | 448 capillary samples were collected<br>from 226 outpatients at three external<br>sites. Capillary blood samples were<br>assayed on the CoaguChek 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: | | |
| | Fingerstick<br>Venous | $y=1.05x + 0.07$<br>$y=0.97x + 0.19$ | 0.95<br>0.95 | 229<br>219 |
| | | | $y=1.089x - 0.17$<br>Slp Cl (1.058, 1.119)<br>Int Cl (-0.25, -0.09)<br>Correlation = 0.958 | |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows a circular logo for the Department of Health and Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The text "HUMAN SERVICES DEPARTMENT" is arranged around the top of the circle.
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850
Ms. Jennifer Tribbett Regulatory Affairs Principal Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457
Re: k021190
Trade/Device Name: PT.S Test Strips and Controls for the CoaguChek System Regulation Number: 21 CFR § 864.7750 Regulation Name: Prothrombin Time Test Regulatory Class: II Product Code: GJS Dated: August 29, 2002 Received: August 30, 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 reguirements for annual registration. Iisting 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 may 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 (OS) 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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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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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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#### 22 119 510(k) Number (if known):
.
Device Name: PT.S Test Strips and Controls for the CoaguChek System
#### Indications for Use:
The CoaguChek System is intended for quantitative Prothrombin Time (PT) testing for monitoring of warfarin therapy, using fresh capillary or non-anticoagulated venous whole blood by professional healthcare providers.
### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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(Division Sign-Division of Clinical Laboratory Devices
510(k) Number K021190
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
