(256 days)
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.
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.
The provided 510(k) summary for the INRatio/INRatio2 Test Strips focuses on demonstrating substantial equivalence to a previously cleared device through non-clinical performance testing. It explicitly states that no clinical data was presented or performed for this submission. Therefore, the information requested in the prompt regarding acceptance criteria, clinical study details, sample sizes for test/training sets, expert involvement, and ground truth establishment primarily relates to clinical studies, which are absent in this submission.
However, based on the provided text, I can extract information about the non-clinical performance testing and the basis for the substantial equivalence determination.
Here's the breakdown of what can be answered and what cannot:
1. A table of acceptance criteria and the reported device performance:
Since no clinical data is presented, there are no specific clinical acceptance criteria or reported clinical performance metrics in this document. The document refers to non-clinical performance testing.
| Acceptance Criteria (Non-Clinical) | Reported Device Performance (Non-Clinical) |
|---|---|
| Equivalent or better performance compared to previously cleared INRatio Test Strips for: | Modified INRatio2 Test Strips have equivalent or better performance compared to the previously cleared INRatio Test Strips for: |
| - Within-day precision | - Within-day precision |
| - Accuracy | - Accuracy |
| - Heparin sensitivity | - Heparin sensitivity |
| - Factor sensitivity | - Factor sensitivity |
| - Potential interferents | - Potential interferents |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not provided in the document. The document only mentions "Performance testing" without specifying sample sizes for the non-clinical tests or their provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable/Not provided. This question pertains to clinical studies and expert review for ground truth, which were not part of this submission by explicit statement.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/Not provided. This question pertains to clinical studies and ground truth establishment, which were not part of this submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a Prothrombin Time (PT) monitoring system, not an AI-assisted diagnostic imaging device that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This question typically applies to AI algorithms. This device is a PT monitoring system (monitor + test strips), which measures PT directly. Its performance is inherent in the device itself, not an algorithm's interpretation of human-generated data.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not provided for non-clinical testing. For the non-clinical performance, the "ground truth" would be established by reference methods or validated laboratory techniques for precision, accuracy, sensitivity, etc., but the specific methodologies are not detailed in this summary.
8. The sample size for the training set:
Not applicable/Not provided. This refers to machine learning algorithms, which are not explicitly mentioned or the focus of this submission. "Training set" typically refers to data used to train an AI model.
9. How the ground truth for the training set was established:
Not applicable/Not provided. As with point 8, this refers to machine learning algorithms.
Summary of Study (Based on Provided Text):
The study was a non-clinical performance comparison of the modified INRatio/INRatio2 Test Strips against the previously cleared INRatio Test Strips (predicate device, K072727).
- Objective: To verify that the modified INRatio2 Test Strips have equivalent or better performance compared to the predicate device.
- Methodology: Performance testing was conducted to evaluate "within-day precision, accuracy, heparin sensitivity, factor sensitivity, and potential interferents."
- Results: The testing "verified that the modified INRatio2 Test Strips have equivalent or better performance" across all assessed parameters.
- Conclusion: Based on this non-clinical data, the INRatio2 Test Strips were deemed substantially equivalent to the predicate device.
- Clinical Data: No clinical validation testing was performed for this submission, as explicitly stated and as per discussions with the reviewer. This implies the substantial equivalence was primarily based on the non-clinical performance data demonstrating that the modifications did not alter the fundamental performance characteristics beyond what was previously cleared.
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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 InnovationsCompany | |
|---|---|---|
| 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.
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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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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
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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
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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
§ 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).