(162 days)
Not Found
No
The summary describes a blood-clotting time measurement system and its performance studies, with no mention of AI, ML, or related concepts.
No
The device measures blood-clotting time to monitor warfarin use, but it does not directly treat a condition or restore a function, which are characteristics of a therapeutic device. It is a diagnostic/monitoring device.
Yes
Explanation: The device measures blood-clotting time to determine if medication levels are appropriate for individuals on warfarin, which is used to monitor a physiological process for making medical decisions.
No
The device description explicitly states "The CoaguChek XS Plus System measures blood-clotting time" and uses "blood from a fingerstick," indicating a physical system with hardware components for blood collection and analysis, not solely software.
Yes, the CoaguChek XS Plus System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The device measures blood-clotting time, which is a diagnostic test performed on a biological sample (blood).
- Sample Type: It uses blood from a fingerstick, which is an in vitro sample.
- Purpose: The measurement of blood-clotting time is used to monitor the effectiveness of warfarin anticoagulation medications, which is a diagnostic purpose.
- Regulatory Context: The document explicitly mentions "premarket notification" and "clearance," which are terms used in the regulatory process for medical devices, including IVDs. The predicate device is also an IVD.
The definition of an IVD generally involves devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The CoaguChek XS Plus System clearly fits this definition.
N/A
Intended Use / Indications for Use
The CoaguChek XS Plus System measures blood-clotting time for people who are taking warfarin anticoagulation medications. The CoaguChek XS Plus System uses blood from a fingerstick. The system is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.
Product codes (comma separated list FDA assigned to the subject device)
GJS
Device Description
The CoaguChek XS Plus System was previously cleared for professional use under premarket notification K071041.
This premarket notification is being submitted to obtain clearance for patient self-testing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
34-86 years
Intended User / Care Setting
properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.
Description of the training set, sample size, data source, and annotation protocol
An external user study was conducted where subjects were self-trained and intended to use the system as intended. Following face-to-face training, the subjects self-tested in the home setting for up to 8 weeks. Sample size not explicitly stated for the training set.
Description of the test set, sample size, data source, and annotation protocol
A clinical study was conducted by Roche Diagnostics, consisting of four visits to the clinical site. Informed consent and randomization occurred at visit 1. Testing began at visit 2. 103 patients completed all visits. The subjects also had 3 scheduled visits to their study site to collect user vs. technician data.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Accuracy Study:
- Study Type: Comparative study comparing test results obtained by trained users with those obtained by healthcare professionals using the CoaguChek XS Plus System.
- Sample Size: N = 307
- Key results: The correlation was very good, as indicated by Slope = 1.000, Intercept = 0.0 and Correlation Coefficient = 0.963. This study shows that trained users are able to obtain results that are as accurate as those obtained by healthcare professionals trained in the use of the CoaguChek XS Plus System.
Precision Study:
- Study Type: Study to calculate the precision of duplicates for capillary blood results for both trained users and healthcare professionals.
- Sample Size: User Results N=296, Professional Results N=308
- Key results:
- User Results: Mean = 2.47, SD = 0.135, CV = 5.47
- Professional Results: Mean = 2.45, SD = 0.101, CV = 4.12
- This study shows that trained users are able to obtain results that are as precise as those obtained by healthcare professionals trained in the use of the CoaguChek XS Plus System.
The study results successfully demonstrated that self-trained subjects can obtain results that are equivalent to healthcare professionals. This study also demonstrated that self-tester results are consistent over time.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Accuracy: Slope = 1.000, Intercept = 0.0, Correlation Coefficient (r) = 0.963, t = 0.8970 (for Accuracy study)
- Precision:
- User Results: Mean = 2.47, SD = 0.135, CV = 5.47
- Professional Results: Mean = 2.45, SD = 0.101, CV = 4.12
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Kosaayd
MAR - 5 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 Corporation
9115 Hague Rd.
Indianapolis, IN 46250
Contact Person: Jennifer Tribbett
Date Prepared: September 22, 2009 |
| 2) Device name | Proprietary name: CoaguChek® XS Plus System
Common name: Prothrombin time test
Classification name: Prothrombin time test |
| 3) Predicate
device | The Roche Diagnostics CoaguChek XS Plus System (patient self-testing) is
substantially equivalent in materials, design and function to other products
that measure prothrombin time INR in human blood. Most notably, it is
substantially equivalent to the Roche Diagnostics CoaguChek XS Plus
System (professional). In fact, it is identical in materials, design and function
to the CoaguChek XS Plus System (professional) except the labeling has been
modified and validated for patient self-testing.
The labeling created for the CoaguChek XS Plus System (patient self-testing)
is substantially equivalent in format and content to the CoaguChek XS
System (patient self-testing). |
| 4) Device
Description | The CoaguChek XS Plus System was previously cleared for professional use
under premarket notification K071041.
This premarket notification is being submitted to obtain clearance for patient
self-testing. |
| 5) Intended Use | The CoaguChek XS Plus System measures blood-clotting time for people
who are taking warfarin anticoagulation medications. The CoaguChek XS
Plus System uses blood from a fingerstick. The system is intended for
properly selected and suitably trained users or their caregivers on the
prescription or other order of the treating doctor. |
| 6) Comparison to
Predicate Device | The following characteristics have been previously submitted, reviewed
and cleared under the premarket notification for the CoaguChek XS Plus
System (K071041): |
| | • Factor Sensitivity |
| | • Heparin Sensitivity |
| | • Hematocrit Effect |
| | • Interfering Substances |
| | • Normal Range |
| | • Measuring Range |
| | • Test Strip Stability |
| | • Integrated (on-board) Quality Control |
| | • Instrument Failsafes |
| | • Calibration |
| | • Software Development |
| | These characteristics are not impacted by the new user population. |
| | The use of the system by self-testers was validated by an external user
study that was conducted as the system is intended to be used. Following
face-to-face training, the subjects self-tested in the home setting for up to 8
weeks. The subjects also had 3 scheduled visits to their study site to
collect user vs. technician data. |
1
The study results successfully demonstrated that self-trained subjects can obtain results that are equivalent to healthcare professionals. This study also demonstrated that self-tester results are consistent over time.
2
The performance characteristics that are impacted by the new user population 7) Performance characteristics were evaluated. The following information has been incorporated into our draft patient self-testing insert.
| Claim | Statement |
|---|---|
| Accuracy | A study was conducted comparing test results obtained by |
| trained users with those obtained by healthcare | |
| professionals, when both were using the CoaguChek XS | |
| Plus System. The correlation was very good, as indicated | |
| by the following statistics: N = 307, Slope = 1.000, | |
| Intercept = 0.0 and Correlation Coefficient = 0.963. This | |
| study shows that trained users are able to obtain results | |
| that are as accurate as those obtained by healthcare | |
| professionals trained in the use of the CoaguChek XS Plus | |
| System. |
Passing-Bablock Regression analysis (Subject vs. Technician) (Overall)
Image /page/2/Figure/3 description: This image is a scatter plot that compares Subject INR to Technician INR. The x-axis represents Technician INR, and the y-axis represents Subject INR, both ranging from 0 to 7. The plot includes a regression line and the equation Y = 0.000 + 1.000 * X, with a sample size of 307. The correlation coefficient (r) is 0.9632, and t = 0.8970.
Continued on next page
3
| Study User
Demographics | A clinical study was conducted by Roche Diagnostics,
consisting of four visits to the clinical site. Informed
consent and randomization occurred at visit 1.
Testing began at visit 2. 103 patients completed all
visits. The following table outlines the demographic
information for the trained users who completed all
visits. |
| ---------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
and the same of the same of the same of the same of the same of the same of the same of the same of the same of the same of the same of the same of the seat of the seat of th
| Demographic | Number | Percent |
|---|---|---|
| Total number of users | 103 | 100% |
| Males | 57 | 55.3% |
| Females | 46 | 44.7% |
| Age range (years) | 34-86 | N/A |
| Mean age (years) | 69 | N/A |
| Age 65-69 years | 20 | 19.4% |
| Age 70-74 years | 23 | 22.3% |
| Age 75 years and up | 46 | 44.7% |
| Educational Level-Some high school through advanced college degree | 103 | 100% |
| Median Educational level | Some college | N/A |
| On warfarin 3-12 months | 12 | 11.7% |
| On warfarin 1-2 years | 12 | 11.7% |
| On warfarin 3-5 years | 23 | 22.3% |
| On warfarin >5 years | 56 | 54.4% |
| Atrial Fibrillation | 27 | 26.2% |
| Valve replacement | 20 | 19.4% |
| Stroke/Stroke Prevention | 7 | 6.8% |
| DVT | 3 | 2.9% |
| Other heart conditions | 22 | 21.4% |
| Other clotting disorders | 24 | 23.3% |
Continued on next page
.
4
| Precision | A study was conducted and the precision of duplicates for capillary blood results was calculated for both trained users and healthcare professionals. The following results were obtained: | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| User Results Professional Results N 296 308 Mean 2.47 2.45 SD 0.135 0.101 CV 5.47 4.12 | ||||||||||||||||
| This study shows that trained users are able to obtain results that are as precise as those obtained by healthcare professionals trained in the use of the CoaguChek XS Plus System. |
:
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 eagle or bird symbol, with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
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
S 2000
Re: K092940
Trade/Device Name: CoaguChek XS Plus PST System Regulation Number: 21 CFR 864.7550 Regulation Name: Prothrombin Time Test Regulatory Class: Class II Product Code: GJS Dated: January 26, 2010 Received: January 27, 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
6
Page 2 - Ms. Jennifer Tribbett
CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (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 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,
()
10%
Reena Philip
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
Indication for Use
510(k) Number (if known): K092940
Device Name: CoaguChek XS Plus System for Patient Self-Testing
Indication For Use:
The CoaguChek XS Plus System measures blood-clotting time for people who are taking warfarin anticoagulation medications. The CoaguChek XS Plus System uses blood from a fingerstick. The system is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.
Prescription Use XXX (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Lenker
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K092940