(123 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies do not indicate the use of such technologies.
No.
The device measures blood-clotting time for monitoring purposes, it does not directly treat or prevent a disease or condition.
Yes
The device "measures blood-clotting time" for individuals taking specific medications, which is a diagnostic function to monitor a patient's health status.
No
The device description explicitly states it is a "meter" and part of a "System" that measures blood-clotting time using blood from a finger stick, indicating a hardware component is involved in the measurement process.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device measures blood-clotting time using blood from a finger stick. This is a test performed in vitro (outside the body) on a biological sample (blood) to provide information about a person's health status (blood clotting).
- Device Description: It is explicitly stated as part of the "CoaguChek XS System," which is a "Roche Diagnostic's CoaguChek meter." The term "Diagnostic" in the company name further reinforces its nature as a diagnostic device.
- Predicate Device: The predicate device is also described as the "Roche Diagnostics CoaguChek XS System (professional)," indicating its diagnostic purpose.
The core function of the device is to perform a diagnostic test on a biological sample, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin® or warfarin. The CoaguChek XS System uses blood from a finger stick. The system is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor. Users should be stabilized on anticoagulation medications such as Coumadin® or warfarin prior to self-testing with the CoaguChek XS System.
Product codes (comma separated list FDA assigned to the subject device)
GJS
Device Description
The CoaguChek XS is a 3rd generation Roche Diagnostic's CoaguChek meter which was cleared for professional use under premarket notification K060978.
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
Not Found
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
self-directed training
Description of the test set, sample size, data source, and annotation protocol
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 as well as user vs. reference method (Dade Innovin on a Sysmex analyzer) data.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Accuracy Study:
A study was conducted comparing test results obtained by self-trained patients with those obtained by healthcare professionals using the CoaguChek XS meter.
N = 258, Slope = 1.00, Intercept = 0.0 and Correlation Coefficient = 0.974.
This study shows that self-trained patients are able to obtain results that are as accurate as those obtained by healthcare professionals trained in the use of the CoaguChek XS meter.
Precision Study:
A study was conducted and the precision of duplicates for capillary blood results was calculated for both self-trained patients and healthcare professionals.
Patient Results: N = 222, Mean = 2.55, SD = 0.132, CV = 5.19
Professional Results: N = 257, Mean = 2.50, SD = 0.135, CV = 5.38 (this value is approximated based on the OCR output of the character "ર :38")
This study shows that self-trained patients are able to obtain results that are as precise as those obtained by healthcare professionals trained in the use of the CoaguChek XS meter.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy Study: Correlation Coefficient = 0.974
Precision Study:
Patient Results: SD = 0.132, CV = 5.19
Professional Results: SD = 0.135, CV = 5.38 (this value is approximated based on the OCR output of the character "ર :38")
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
JAN 2 9 2007
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: Luann Ochs
Date Prepared: January 29, 2007 |
| 2) Device name | Proprietary name: CoaguChek® XS System
Common name: Prothrombin time test
Classification name: Prothrombin time test |
| 3) Predicate device | The Roche Diagnostics CoaguChek XS 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 System (professional). In fact, it is identical in materials, design and function to the CoaguChek XS System (professional) except the labeling has been modified and validated for patient self-testing. |
| 4) Device Description | The CoaguChek XS is a 3rd generation Roche Diagnostic's CoaguChek meter which was cleared for professional use under premarket notification K060978.
This premarket notification is being submitted to obtain clearance for patient self-testing. |
| 5) Intended Use | The CoaguChek XS PT test strips are part of the CoaguChek XS
System. The CoaguChek XS System measures blood-clotting time for people
who are taking anticoagulation medications such as Coumadin® or
warfarin. The CoaguChek XS System uses blood from a finger stick. The
system is intended for properly selected and suitably trained users or their
caregivers on the prescription or other order of the treating doctor. Users
should be stabilized on anticoagulation medications such as Coumadin® or
warfarin prior to self-testing with the CoaguChek XS System. |
| 6) Comparison to
Predicate Device | The following characteristics have been previously submitted, reviewed
and cleared under the premarket notification for the CoaguChek XS
System (K060978):
•Factor Sensitivity
•Heparin Sensitivity
•Hematocrit Effect
•Interfering Substances
•Normal Range
•Measuring Range
•Test Strip Stability
•Integrated 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
self-directed 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 as well as user vs. reference method (Dade
Innovin on a Sysmex analyzer) data.
The study results successfully demonstrated that self-trained subjects can
obtain results that are equivalent to healthcare professionals and to the
reference method. This study also demonstrated that self-tester results are
consistent over time. |
1
:
・
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 self-trained patients with those obtained | ||||
| by healthcare professionals using the CoaguChek XS | ||||
| meter. The correlation was very good, as indicated by | ||||
| the following statistics: N = 258, Slope = 1.00, | ||||
| Intercept = 0.0 and Correlation Coefficient = 0.974. | ||||
| This study shows that self-trained patients are able to | ||||
| obtain results that are as accurate as those obtained by | ||||
| healthcare professionals trained in the use of the | ||||
| CoaguChek XS meter. | ||||
| Precision | A study was conducted and the precision of duplicates | |||
| for capillary blood results was calculated for both | ||||
| self-trained patients and healthcare professionals. | ||||
| The following results were obtained: | ||||
| Patient Results | ||||
| Professional Results | ||||
| N | 222 | 257 | ||
| Mean | 2.55 | 2.50 | ||
| SD | 0.132 | 0.135 | ||
| CV | 5.19 | ર :38 | ||
| This study shows that self-trained patients are able to | ||||
| obtain results that are as precise as those obtained by | ||||
| healthcare professionals trained in the use of the | ||||
| CoaguChek XS meter. |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. 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
ROCHE Diagnostics Corp. C/O Jennifer Tribbett 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250
JAN 2 9 2007
Re: K062925
Trade/Device Name: CoaguChek® XS System for Patient Self-testing Regulation Number: 21 CFR 864.7750 Regulation Name: Prothrombin Time Test Regulatory Class: Class II Product Code: GJS Dated: September 27, 2006 Received: September 28, 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 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 (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. 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
4
Page 2 –
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), please contact the Office of Compliance at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert A. Becker, Jr.
Robert L. Becker, Jr., MD, PhI Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Page 3 -
:
the country of the country of the county of
cc: HFZ-401 DMC
.
:
and the comments of the comments of the comments of
:
and the comments of the comments of the comments of
HFZ-404 510(k) Staff HFZ- 440 Division D.O.
6
Indications for Use
510(k) Number (if known):_-K060978- |