(256 days)
Not Found
No
The description focuses on electrochemical detection of clotting time and does not mention AI/ML terms or methodologies.
No
The device is an in vitro diagnostic (IVD) device used for monitoring Prothrombin Time (PT) in blood, which is a diagnostic function, not a therapeutic one. It provides information for managing anticoagulant therapy but does not directly treat or prevent a condition.
Yes
The device is described as an "in vitro diagnostic use" system that measures Prothrombin Time (PT) for monitoring blood thinning therapy, which falls under diagnostic purposes.
No
The device description explicitly states the system consists of a monitor and disposable test strips, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "The INRatio/INRatio2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use)."
- Device Description: The description details how the device measures Prothrombin Time (PT) in a blood sample outside the body using a test strip and monitor. This is the core function of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The INRatio/INRatio2 PT Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio/INRatio2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use). The INRatio2 PT Monitoring system is intended for professional and home use by people taking warfarin and other oral anticoaqulant (blood thinning) therapy who need to monitor the of their blood. The INRatio/INRatio2 PT Monitoring system is not intended to be used for screening purposes.
Product codes
GJS
Device Description
The INRatio/INRatio2 Test Strips perform a modified version of the one-stage Prothrombin Time test, using a recombinant human thromboplastin reagent. The clot formed in the Prothrombin Time reaction is detected by a change in the electrical impedance of the sample during the coagulation process. The system consists of a monitor and disposable test strips. The monitor measures impedance, heats the test strip to the proper reaction temperature, and provides a user interface. The blood sample is applied to the Test Strip and the clotting reaction occurs on the Test Strip.
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
professional and home use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing verified that the modified INRatio2 Test Strips have equivalent or better performance compared to the previously cleared INRatio Test Strips with respect to within-day precision, accuracy, heparin sensitivity, factor sensitivity, and potential interferents.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _
| A. Submitter: | Biosite Incorporated, an Inverness Medical Innovations
Company | |
|----------------|-------------------------------------------------------------------|-------------|
| | 9975 Summers Ridge Road | |
| | San Diego, CA 92121 USA | |
| Contact: | Karin A. Hughes, Ph.D. | JUN 11 2016 |
| | Director, Regulatory Affairs | |
| Telephone: | 858.805.3628 | |
| Fax; | 858.695.7100 | |
| Email: | khughes@biosite.com | |
| Date Prepared: | April 13, 2010 | |
Device Names: B.
| Classification name | Prothrombin Time Test |
|---|---|
| Common/usual name | Prothrombin Time Test |
| Proprietary name | INRatio Test Strips |
INRatio2 System, K072727 C. Predicate Device:
D. Device Description:
The INRatio/INRatio2 Test Strips perform a modified version of the one-stage Prothrombin Time test, using a recombinant human thromboplastin reagent. The clot formed in the Prothrombin Time reaction is detected by a change in the electrical impedance of the sample during the coagulation process. The system consists of a monitor and disposable test strips. The monitor measures impedance, heats the test strip to the proper reaction temperature, and provides a user interface. The blood sample is applied to the Test Strip and the clotting reaction occurs on the Test Strip.
ய் Intended Use:
The INRatio/INRatio2 PT Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio/INRatio2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use). The INRatio2 PT Monitoring system is intended for professional and home use by people taking warfarin and other oral anticoaqulant (blood thinning) therapy who need to monitor the of their blood. The INRatio/INRatio2 PT Monitoring system is not intended to be used for screening purposes.
1
The INRatio and INRatio2 PT Monitoring Systems consist of the INRatio2 Monitor and the INRatio Test Strips.
F. Comparison with the Predicate Device:
The modified INRatio/INRatio2 Test Strips are substantially equivalent to the previously cleared INRatio Test Strips (K072727 and Add-to-File, Sept. 24, 2007) currently marketed and distributed by Biosite Incorporated. The modified INRatio/INRatio2 Test Strips are a labelling/performance claims modification of the current INRatio Test Strips.
G. Nonclinical Data:
Performance testing verified that the modified INRatio2 Test Strips have equivalent or better performance compared to the previously cleared INRatio Test Strips with respect to within-day precision, accuracy, heparin sensitivity, factor sensitivity, and potential interferents.
H. Clinical Data
Clinical data are not presented in this submission; no clinical validation testing was performed for this submission, per discussions with the reviewer.
-Conclusions Drawn from Testing
Based on the data and information presented here, the INRatio2 Test Strips are substantially equivalent to the INRatio Test Strips currently manufactured and distributed by Biosite Incorporated.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/13 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple and recognizable, representing the department's role in public health and human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center-WO66-G609 Silver Spring, MD 20993-0002
Biosite Incorporated c/o Karin A. Hughes, Ph.D. Director, Regulatory Affairs 9975 Summers Ridge Road San Diego, CA 92121
JUN 1 1 2010
Re: K092987
INRatio/INRatio2 Test Strips Regulation Number: 21 CFR 864.7750 Regulation Name: Prothrombin Time Test Regulatory Class: Class II Product Code: GJS Dated: April 13, 2010 Received: April 13, 2010
Dear Dr. Hughes:
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 (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
3
Page 2 - Karin A. Hughes, PhD
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,
Reeva Philip
for Maria M. Chan, PhD Director
Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _ K092987
Device Name: INRatio/INRatio2 Test Strips
Indications for Use:
The INRatio/INRatio2 PT Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio/INRatio2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use). The INRatio/INRatio2 PT Monitoring system is intended for professional and home use by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio/INRatio 2 PT Monitoring system is not intended to be used for screening purposes.
Prescription Use X (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)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K092987