(132 days)
The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"), using capillary blood or whole blood from a vein (nonanticoagulated venous whole blood). It is indicated for use by healthcare professionals. The system is ideally suited to monitor coagulation values in people who are taking oral anticoagulation medication (vitamin K antagonists, VKAs).
The CoaguChek XS Pro System represents a modification of the CoaguChek XS Plus System to incorporate an embedded barcode scanner. The unmodified device was cleared for use under premarket notification K071041. The intended use of the modified device, as described in its labeling, has not changed as a result of the modification(s) described in this 510(k). The fundamental scientific technology of this device has not changed as a result of the modification(s) described in this 510(k).
The provided text is a 510(k) summary for the CoaguChek XS Pro System. It indicates that the device is a modification of a previously cleared device (CoaguChek XS Plus System) and that the intended use and fundamental scientific technology have not changed.
The document does not describe an acceptance criteria study for the CoaguChek XS Pro System because it is presented as a modification of an already cleared device, the CoaguChek XS Plus System (K071041). The core performance characteristics (accuracy, precision, measuring range, hematocrit range, bilirubin, triglyceride, hemolysis, heparin, LMWH effects) are stated to be "Same" as the predicate device.
Therefore, the study to "prove the device meets the acceptance criteria" refers to the studies that established the performance of the predicate CoaguChek XS Plus System, as indicated by the "Same" designation.
Here's an analysis based on the information provided, focusing on the predicate device's performance as accepted for the modified device:
1. Table of Acceptance Criteria and Reported Device Performance
Since this submission is a modification of an existing device, the "acceptance criteria" are implied to be that the performance of the CoaguChek XS Pro System is "Same" as the previously cleared CoaguChek XS Plus System. The performance characteristics reported for the predicate device are listed as the acceptable performance for the modified device.
| Performance Characteristic | Acceptance Criteria (from predicate CoaguChek XS Plus System) | Reported Device Performance (CoaguChek XS Pro System) |
|---|---|---|
| Accuracy compared to the reference | Venous Blood: N=811, Slope= 1.090, Intercept = -0.2, Correlation = 0.974 Capillary Blood: N = 822, Slope = 1.075, Intercept = -0.1, Correlation = 0.972 | Same as predicate (implied to meet these criteria) |
| Whole Blood Precision | Venous Blood: N = 399, Mean INR = 2.32, SD = 0.046, CV = 2.00 Capillary Blood: N = 399, Mean INR = 2.26, SD = 0.077, CV = 3.39 | Same as predicate (implied to meet these criteria) |
| Control Precision | Level 1: N = 538, Mean INR = 1.18, SD = 0.04, CV = 3.37 Level 2: N = 535, Mean INR = 2.95, SD = 0.12, CV = 4.10 | Same as predicate (implied to meet these criteria) |
| Measuring range | 0.8 – 8.0 INR | Same |
| Hematocrit range | Hematocrit ranges between 25 – 55% have no significant effect on test results | Same |
| Bilirubin | Bilirubin up to 30 mg/dL have no significant effect on test results | Same |
| Triglyceride | Lipemic samples containing up to 500 mg/dL of triglycerides have no significant effect on test results. | Same |
| Hemolysis | Hemolysis up to 1000 mg/dL have no significant effect on test results | Same |
| Heparin | Test results are unaffected by heparin concentrations up to 0.8 U/mL | Same |
| Low Molecular Weight Heparin (LMWH) | The CoaguChek XS PT Test is insensitive to low molecular weight heparins (LMWH) up to 2IU anti-factor Xa activity/mL | Same |
2. Sample Sizes and Data Provenance for the Test Set
The provided summary does not explicitly state the country of origin or whether the data was retrospective or prospective. However, the sample sizes for the performance characteristics which are attributed to the predicate device are:
- Accuracy (Venous Blood): N = 811
- Accuracy (Capillary Blood): N = 822
- Whole Blood Precision (Venous Blood): N = 399
- Whole Blood Precision (Capillary Blood): N = 399
- Control Precision (Level 1): N = 538
- Control Precision (Level 2): N = 535
3. Number of Experts and Qualifications for Ground Truth
The document does not provide information about the number of experts used or their qualifications for establishing ground truth for the test set. For in vitro diagnostic devices like this, the "ground truth" (or reference method) is typically established by laboratory reference instruments or validated manual methods, not human expert interpretation in the same way it would be for imaging devices.
4. Adjudication Method
The document does not describe any adjudication method as it relates to expert review of results. For in vitro diagnostic assays, the comparison is typically against a reference laboratory method rather than an adjudicated human interpretation.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. This type of study is usually conducted for imaging or interpretation-based diagnostic devices to evaluate the impact of AI on human reader performance. This device is an in-vitro diagnostic (IVD) test, where the instrument directly provides a quantitative result.
6. Standalone Performance
Yes, standalone performance was done for the predicate device, and the modified device's performance is stated to be the "Same." The reported accuracy and precision values are measures of the algorithm's (or system's) performance in determining prothrombin time against a reference. The device provides a quantitative result without human intervention for interpretation beyond reading the displayed value.
7. Type of Ground Truth Used
The ground truth used for the predicate device's performance evaluation would have been a reference laboratory method for prothrombin time (PT) or International Normalized Ratio (INR). This is implied by the terms "Accuracy compared to the reference" and the quantitative nature of the results (INR values).
8. Sample Size for the Training Set
The document does not provide information on the sample size used for the training set. For an in-vitro diagnostic device based on electrochemical technology, the "training set" might not be relevant in the same way it is for machine learning algorithms. Instead, the device's operational parameters would be established through extensive analytical validation using samples with known values.
9. How Ground Truth for the Training Set was Established
Similar to the test set, the ground truth for any calibration or validation of the device during its development (analogous to a "training set") would have been established using reference laboratory methods for PT/INR.
{0}------------------------------------------------
MAR 1 8 2010
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 Corporation9115 Hague Rd.Indianapolis, IN 46250Contact Person: Jennifer TribbettDate Prepared: March 15, 2010 |
|---|---|
| 2) Device name | Proprietary name: CoaguChek® XS Pro SystemCommon name: Prothrombin time testClassification name: Prothrombin time test |
| 3) Predicate device | The CoaguChek XS Pro System is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, the CoaguChek XS Pro System is a modification of the previously cleared CoaguChek XS Plus System (K071041). |
| 4) Device Description | The CoaguChek XS Pro System represents a modification of the CoaguChek XS Plus System to incorporate an embedded barcode scanner. The unmodified device was cleared for use under premarket notification K071041.The intended use of the modified device, as described in its labeling, has not changed as a result of the modification(s) described in this 510(k).The fundamental scientific technology of this device has not changed as a result of the modification(s) described in this 510(k). |
{1}------------------------------------------------
| 5) Intended Use The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoguChekXS PT Test strips) quantitatively determines prothrombin time ("PT"), usingcapillary blood or whole blood from a vein (nonanticoagulated venous wholeblood). It is indicated for use by healthcare professionals. The system isideally suited to monitor coagulation values in people who are taking oralanticoagulation medication (vitamin K antagonists. VKAs). |
|---|
6) Similarities The table below indicates the similarities between the CoaguChek XS Plus System and the CoaguChek XS Pro System.
| Topic | CoaguChek XS Plus System(predicate: unmodified device) | CoaguChek XS Pro System(modified device) |
|---|---|---|
| General Features | ||
| Intended use | Intended for use by professionalhealthcare providers for quantitativeprothrombin time testing for themonitoring of warfarin therapy. | The CoaguChek XS Pro System(CoaguChek XS Pro meter andCoguChek XS PT Test strips)quantitatively determinesprothrombin time (“PT”), usingcapillary blood or whole blood froma vein (nonanticoagulated venouswhole blood). It is indicated for useby healthcare professionals. Thesystem is ideally suited to monitorcoagulation values in people whoare taking oral anticoagulationmedication (vitamin K antagonists,VKAs). |
| Fundamental technology | Electrochemical technology withamperometric (electric current) detectionof thrombin activity | Same |
| Sample type | Fresh capillary or non-anticoagulatedvenous whole blood | Same |
| Test strip | The CoaguChek XS PT Test Strip | Same |
| Onboard control | Built into every strip and recognized bythe meter | Same |
| External quality control | CoaguChek XS PT Controls are availableas optional external controls | Same |
{2}------------------------------------------------
| Topic | CoaguChek XS Plus System(predicate: unmodified device) | CoaguChek XS Pro System(modified device) |
|---|---|---|
| System Performance Characteristics | ||
| Measuring range | 0.8 – 8.0 INR | Same |
| Hemotocrit range | Hematocrit ranges between 25 – 55%have no significant effect on test results | Same |
| Bilirubin | Bilirubin up to 30 mg/dL have nosignificant effect on test results | Same |
| Triglyceride | Lipemic samples containing up to 500mg/dL of triglycerides have nosignificant effect on test results. | Same |
| Hemolysis | Hemolysis up to 1000 mg/dL have nosignificant effect on test results | Same |
| Heparin | Test results are unaffected by heparinconcentrations up to 0.8 U/mL | Same |
| Topic | CoaguChek XS Plus System(predicate: unmodified device) | CoaguChek XS Pro System(modified device) |
| System Performance Characteristics | ||
| Low Molecular WeightHeparin | The CoaguChek XS PT Test isinsensitive to low molecular weightheparins (LMWH) up to 2IU anti-factorXa activity/mL | Same |
| Accuracy compared tothe reference | Venous Blood:N=811Slope= 1.090Intercept = -0.2Correlation = 0.974Capillary Blood:N = 822Slope = 1.075Intercept = -0.1Correlation = 0.972 | Same |
| Whole Blood Precision | Venous Blood:N = 399Mean INR = 2.32SD = 0.046CV = 2.00Capillary Blood:N = 399Mean INR = 2.26SD = 0.077CV = 3.39 | Same |
| Control Precision | Level 1:N = 538Mean INR = 1.18SD = 0.04CV = 3.37Level 2:N = 535Mean INR = 2.95SD = 0.12CV = 4.10 | Same |
| Topic | CoaguChek XS Plus System(predicate: unmodified device) | CoaguChek XS Pro System(modified device) |
| Hardware | ||
| Measurement module(Measurement engine) | Converts raw signals from test strip intofinal PT result. | SameMeasurement Module has not beenmodified |
| Handheld Basic Module | Provides the power management of theAC-adapter or rechargeable batteries andhouses all the data management features. | SameHandheld Basic Module has notbeen modified |
| Software | ||
| Code chip function | Code chip information is stored in meterto identify test strip and liquid controlinformation. | Same |
·
{3}------------------------------------------------
:
・
.
{4}------------------------------------------------
The table below indicates the modified features of the CoaguChek XS Pro System. 7) Differences
.
| Topic | CoaguChek XS Plus System(predicate: unmodified device) | CoaguChek XS Pro System(modified device) |
|---|---|---|
| General Features | ||
| Note: The test strip itself has not been modified | ||
| Capillary sample volume | Blood drop must be minimum 10 µl | Blood drop must be minimum 8 µl |
| Code Chip Modifications | ||
| Blood application time | 120 seconds | 180 seconds |
| Operating temperature | 18° - 32 °C | 15° - 32 °C |
| Hardware | ||
| Barcode Scanner | External Barcode Scanner | Integrated Barcode Scanner |
| Display | LED Display | TFT Display |
| Size | 185 x 98 x 42 mm | 231 x 97 x 43 mm |
| Weight | 311 g (without batteries) | 350 g (without batteries) |
| Software | ||
| Memory | 500 INR results, 500 QC results | 1000 INR results, 500 QC results |
| Display | User interface shows images/icons | Upgraded display showsimages/icons and more descriptivetext. |
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center-WO66-G609 Silver Spring, MD 20993-0002
Roche Diagnostics c/o Ms. Jennifer Tribbett Regulatory Program Manager 9115 Hague Road Indianapolis, Indiana 46250
Re: K093460
Trade/Device Name: Coaguchek XS Pro System
Regulation Number: 21 CFR 864.7750 Regulation Name: Prothrombin time test Regulatory Class: Class II Product Code: GJS Dated: February 8, 2010 Received: February 12, 2010
MAR 1 8 2010
:
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 class II (Special Controls), 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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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
{6}------------------------------------------------
Page 2 – Ms. Jennifer Tribbett
your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
ie m chan
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{7}------------------------------------------------
Indications for Use Form
510(k) Number (if known): K093460
CoaguChek XS Pro System Device Name:
Indications For Use:
The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"), using capillary blood or whole blood from a vein (nonanticoagulated venous whole blood). It is indicated for use by healthcare professionals. The system is ideally suited to monitor coagulation values in people who are taking oral anticoagulation medication (vitamin K antagonists, VKAs).
Prescription Use XXX (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 In Vitro Diagnostic Devices (OIVD)
GENERAL CERTIFICATE OF SECONDARY E
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) KC9346.0
Page 1 of 1
§ 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).