The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The CoaguChek XS System uses fresh capillary or non-anticoagulated venous whole blood.

Device Description

The CoaguChek XS is a 3rd generation CoaguChek meter which measures prothrombin time in fresh capillary or non-anticoagulated venous whole blood samples. The CoaguChek XS System incorporates many of the perspectives shared by FDA during reviews of our previous systems, including but not limited to integrated quality control and a blood application area that is outside the meter. The CoaguChek XS System includes a meter and CoaguChek XS PT test strips. Each box of test strips has its own code chip that you insert into the meter. The code chip contains important information about the test strips such as their expiration date and lot number. The meter and test strips work together to provide a safe and reliable system for testing blood-clotting time.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the CoaguChek® XS System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document compares the CoaguChek XS System to its predicate, the CoaguChek S System, across various performance characteristics. While explicit "acceptance criteria" (i.e., predefined thresholds for success) are not formally stated with numerical targets, the comparison table implicitly defines them by demonstrating performance that is either equivalent to or improved upon the predicate device.

Performance Characteristic	Acceptance Criteria (Implicit - based on predicate or improved performance)	CoaguChek XS System Reported Performance
Bilirubin Interference	No significant effect up to 20 mg/dL (predicate)	No significant effect up to 30 mg/dL
Hemolysis Interference	No significant effect up to 500 mg/dL (predicate)	No significant effect up to 1000 mg/dL
Triglycerides Interference	No significant effect up to 500 mg/dL (predicate)	No significant effect up to 500 mg/dL
Hematocrit Range	Not significantly affected between 32 - 52% (predicate)	Not significantly affected between 25 - 55%
Heparin Insensitivity	Unaffected up to 2.0 U/mL (predicate)	Unaffected up to 0.8 U/mL*
Low Molecular Weight Heparin Insensitivity	Insensitive up to 1 IU anti-factor Xa activity/mL (predicate)	Insensitive up to 2 IU anti-factor Xa activity/mL
Capillary Accuracy (vs. Lab Analyzer Plasma)	Correlation (R) of 0.965 (predicate)	Correlation (R): 0.971 (N=700)
Venous Accuracy (vs. Lab Analyzer Plasma)	Correlation (R) of 0.970 (predicate)	Correlation (R): 0.974 (N=710)
Whole Blood Precision (Venous)	CV = 4.43 (predicate)	CV = 2.42 (N=357)
Whole Blood Precision (Capillary)	CV = 7.19 (predicate)	CV = 4.35 (N=344)

*Note: The heparin insensitivity for CoaguChek XS is lower than the predicate. This is a difference from the predicate, not necessarily an "improvement" in this specific metric. However, the overall device was found substantially equivalent.

2. Sample Size for Test Set and Data Provenance

Capillary Accuracy: N=700 (combined across all sites)
Venous Accuracy: N=710 (combined across all sites)
Whole Blood Precision (Venous): N=357
Whole Blood Precision (Capillary): N=344
Data Provenance: The document states that precision was determined from samples collected at "three external sites" for the CoaguChek XS and "five external sites" for the predicate venous blood and "four external sites" for the predicate capillary blood. The specific country of origin is not specified, but the context of an FDA submission suggests studies likely conducted in or compliant with standards in North America or internationally accepted clinical study practices. It refers to "fresh capillary or non-anticoagulated venous whole blood samples," implying prospective collection for the purpose of the study.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided in the given text. The "ground truth" for Prothrombin Time (PT) tests here is a comparison against a laboratory-based reference method, not an expert assessment of images or clinical diagnoses. The reference methods mentioned are:

Capillary Accuracy: Sysmex Analyzer using Dade Innovin (ISI = 1.02)
Venous Accuracy: Sysmex Analyzer using Dade Innovin (ISI = 1.02)
Predicate device comparison: MLA 900 using Ortho Recombiplastin (ISI = 1.03)

These are recognized automated laboratory coagulation analyzers, not human experts.

4. Adjudication Method for the Test Set

This information is not applicable as the ground truth is established by a laboratory reference analyzer, not human reviewers requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable as the device is a diagnostic testing system (measuring prothrombin time), not an imaging device requiring human interpretation for diagnosis. Therefore, there's no "human readers improve with AI vs without AI assistance" scenario.

6. Standalone (Algorithm Only) Performance

Yes, this study primarily assesses the standalone performance of the CoaguChek XS System by comparing its results directly to established laboratory reference methods. The device itself is an automated system, and its output (INR values) is the direct result of its internal algorithm and electrochemical technology.

7. Type of Ground Truth Used

The ground truth used is comparison to a laboratory-based reference method (Sysmex Analyzer using Dade Innovin) for Prothrombin Time (PT) and International Normalized Ratio (INR) measurements. This is considered a highly objective standard for in vitro diagnostic devices like this.

8. Sample Size for the Training Set

The provided text does not specify the sample size for a training set. Given the context of a 510(k) summary, the focus is on performance validation rather than the details of algorithm development (which would typically involve training data). The "CoaguChek XS is a 3rd generation CoaguChek meter," suggesting iterative development, but specific training set details are omitted.

9. How Ground Truth for Training Set was Established

This information is not provided in the document as training set details are not described.

Summary

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K060978

AUG 】】2006

510(k) Summary

Introduction	According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence.
1) Submittername, address,contact	Roche Diagnostics Corporation9115 Hague Rd.Indianapolis, IN 46250
	Contact Person: Jennifer Tribbett
	Date Prepared: April 6, 2006
2) Device name	Proprietary name: CoaguChek® XS SystemCommon name: Prothrombin time testClassification name: Prothrombin time test
3) Predicatedevice	The Roche Diagnostics CoaguChek XS System is substantially equivalent toother products in commercial distribution intended for similar use. Mostnotably, it is substantially equivalent to the Roche Diagnostics CoaguChek SSystem (K020831).
4) DeviceDescription	The CoaguChek XS is a 3rd generation CoaguChek meter which measuresprothrombin time in fresh capillary or non-anticoagulated venous whole bloodsamples.The CoaguChek XS System incorporates many of the perspectives shared byFDA during reviews of our previous systems, including but not limited tointegrated quality control and a blood application area that is outside the meter.The CoaguChek XS System includes a meter and CoaguChek XS PT teststrips. Each box of test strips has its own code chip that you insert into themeter. The code chip contains important information about the test strips suchas their expiration date and lot number. The meter and test strips worktogether to provide a safe and reliable system for testing blood-clotting time.

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The CoaguChek XS System is intended for use by professional healthcare 5) Intended Use providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The CoaguChek XS System uses fresh capillary or nonanticoagulated venous whole blood.
The CoaguChek XS System is similar to the predicate CoaguChek S 6) Similarities to predicate device System in the following items:

Topic	Comment
Intended Use	Both are intended to be used by professional healthcareproviders for the quantitative prothrombin time (PT) testingto monitor warfarin therapy, using fresh capillary or non-anticoagulated venous whole blood.
Measuring Range	Both systems have a measuring range of 0.8 – 8.0 INR.
Closed System	Both systems use instrument and reagent strips that areprovided by Roche and are intended to be used together.
Specimen collection andpreparation instructions	These instructions are the same for both systems.
Sample Volume	Both require a minimum of 10 $ $\mu$ $ L capillary blood
Thromboplastin	Both contain human recombinant thromboplastin, stabilizersand preservatives.
International Sensitivity Index	Both have an ISI established as 1.
Calibration of results	Both systems are traceable to the WHO reference method.

The following table lists the major differences between the CoaguChek 7) Differences from predicate device XS System and the predicate CoaguChek S System.

Topic	CoaguChek XS System	CoaguChek S System (Predicate)
Technology	Electrochemical technology withamperometric (electric current)detection of thrombin activity.	Dancing particle technology withoptical detection of thrombin activity.
Quality Control	On-board fully integrated qualitycontrols which use electrochemicalsignals to detect test strip integrity.	Liquid controls and externalelectronic quality control
Test Strip Dosing	Top and side dosing	Top dosing only
Start up	Instrument turns on with either theinsertion of the test strip or the pushof a button	Instrument turns on with the push of abutton
Memory	100 test results with time & date	60 test results with time & date
Claim	CoaguChek XS System	CoaguChek S System(Predicate)
Bilirubin	No significant effect up to 30 mg/dL	No significant effect up to 20 mg/dL
Hemolysis	No significant effect up to 1000 mg/dL	No significant effect up to 500 mg/dL
Triglycerides	No significant effect up to 500 mg/dL	No significant effect up to 500 mg/dL
Hematocrit	Hematocrit ranges between 25 - 55%do not significantly affect test results.	Hematocrit ranges between 32 - 52%do not significantly affect test results.
Heparin	Unaffected by heparin concentrationsup to 0.8 U/mL.	Unaffected by heparin concentrationsup to 2.0 U/mL.
Low MolecularWeight Heparin	Insensitive to low molecular weightheparins up to 2 IU anti-factor Xaactivity/mL.	Insensitive to low molecular weightheparins up to 1 IU anti-factor Xaactivity/mL.
CapillaryAccuracy(All Sites)	Capillary blood on CoaguChek XS vs.venous plasma on a Sysmex Analyzerusing Dade Innovin (ISI = 1.02)N= 700$y= 1.006x + 0.032$Correlation: 0.971	Capillary blood on CoaguChek S vs.venous plasma on MLA 900 usingOrtho Recombiplastin (ISI = 1.03)N= 539$y= 1.150x - 0.25$Correlation: 0.965
VenousAccuracy(All Sites)	Venous Whole Blood:CoaguChek XS vs. Sysmex Analyzerusing Dade Innovin (ISI = 1.02)N= 710$Y= 1.034x - 0.02$Correlation: 0.974	Venous Whole Blood:CoaguChek S vs. MLA 900 usingOrtho Recombiplastin (ISI = 1.03)N= 761$Y= 1.150x - 0.24$Correlation: 0.970
Claim	CoaguChek XS System	CoaguChek S System
		(Predicate)
Precision withblood	Whole blood precision for venous andcapillary samples was determined fromsample duplicates collected at threeexternal sites.	Whole blood precision wasdetermined from sample duplicates atfive external sites for the venousblood and four external sites for thecapillary blood.
	Bland Altman plots for both capillaryand venous blood are provided in thetest strip insert.	Bland Altman plots for both capillaryand venous blood are provided in thetest strip insert.
The following information representsthe data that is graphically shown bythe Bland Altman plots.	Venous:	The following information representsthe data that is graphically shown bythe Bland Altman plots.
	Venous:	Venous:
	N = 357Mean = 2.59 INRSD = 0.06CV = 2.42	N = 376Mean = 2.5 INRSD = 0.11CV = 4.43
	Capillary:	Capillary:
	N = 344Mean = 2.59 INRSD = 0.11CV = 4.35	N = 268Mean = 2.1 INRSD = 0.15CV = 7.19

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The following chart shows a comparison of performance characteristic 8) Performance characteristics claims for the CoaguChek XS System and the CoaguChek S System.

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Performance -Continuedcharacteristics

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 1 1 2006

ROCHE DIAGNOSTICS c/o Jennifer Tribbett 9115 Hague Road Indianapolis, IN 46256

Re: K060978/S001 CoaguChek® XS System Regulation Number: 21 CFR 864.7750 Regulation Name: Prothrombin Time Test Regulatory Class: Class II Product Code: GJS Dated: April 6, 2006 Received: April 10, 2006

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed

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predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, rryou don't specific introlion and advertising of your device, please contact the Office of In of questions on the proce Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation other general information on your responsibilities under the Act from the Tou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Robert L. Betz

Robert L. Becker, Jr., MD. PMD. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

K060978

Device Name: CoaguChek® XS System

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aurghine Bautista
Division Sign-Off

Page 1 of 1

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K060978

Regulation Number and Section

§ 864.7750 Prothrombin time test.

(a)
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).(b)
Classification. Class II (performance standards).