(207 days)
Not Found
No
The description details a mechanical and optical detection method for clot formation and calculation of INR, with no mention of AI or ML.
No
The device is a diagnostic tool used for quantitative testing of Prothrombin Time, providing information (INR values) that helps monitor patients on anticoagulant therapy. It does not directly provide therapy or treatment.
Yes
The device quantitatively tests Prothrombin Time in capillary blood and displays results as an International Normalized Ratio (INR) value, which is used to monitor patients on oral anticoagulant therapy. This measurement provides diagnostic information about a patient's coagulation status.
No
The device description clearly outlines hardware components including a hand-held battery-powered meter, ROM calibration chip, disposable test strips, and external liquid controls. The process involves physical interaction with blood, a magnetic field, and optical detection, indicating a hardware-based system.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative testing of Prothrombin Time in capillary blood." This involves testing a biological sample (blood) in vitro (outside the body) to obtain diagnostic information (Prothrombin Time/INR).
- Device Description: The description details a system that uses a test strip with reagents to react with the blood sample and measure a biological process (clot formation) to determine a result. This is characteristic of an in vitro diagnostic device.
- Performance Studies: The performance studies evaluate the device's accuracy and precision in measuring INR from blood samples, comparing it to other methods of measuring INR. This type of evaluation is standard for IVD devices.
- Predicate Devices: The listed predicate devices (CoaguChek® S System) are well-known IVD devices for INR testing. This further supports the classification of the SmartCheck INR System as an IVD.
The core function of the device is to analyze a biological sample (capillary blood) outside the body to provide diagnostic information (INR) about a patient's coagulation status. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SmartCheck INRTM System is intended for quantitative testing of Prothrombin Time in capillary blood. Results are given in International Normalized Ratio (INR) units.
The SmartCheck INR System is indicated for use by trained medical professionals in a point of care setting for monitoring the INR of patients on oral anticoagulant therapy.
Product codes
JPA
Device Description
The SmartCheck INRTM system consists of a hand held battery-powered meter with ROM calibration chip, disposable, dual-chambered, test strips and high and low level external liquid controls. When blood is applied to the strip it migrates by capillary action to the reaction chambers of the strip. The reaction chamber contains a metallic disc and rabbit brain thromboplastin reagent. When blood enters the reaction chamber a magnetic field is applied to the strip to activate disc movement. Upon clot formation, the disc becomes immobilized and clotting is optically detected. Clotting time is calculated and displayed as an INR value.
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
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Intended User / Care Setting
trained medical professionals in a point of care setting
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The SmartCheck INRTM System was evaluated for non-clinical and clinical performance. SmartCheck INR passed all tests and correlated favourably to a venous plasma based PT test with respect to accuracy and precision. A summary of the results is presented below for combined site calculations and support the conclusion that the SmartCheck INRTM System is substantially equivalent to the predicate CoaguChek S System.
Accuracy: SmartCheck INR Capillary Blood v. Venous Plasma INR ACL 10000 with recombinant thromboplastin (recTP), PTHS+ reagent and PT/Fibrinogen reagent (PT/Fib).
recTP: n=315, Regression Curve y=1.17x-0.49, Correlation Coefficient 0.9235, Slope 1.17, Intercept -0.49, Range x 1.2 to 6.2, Range y 0.9 to 7.2, Sy,x 0.250
PTHS+: n=310, Regression Curve y=1.48x-1.19, Correlation Coefficient 0.9009, Slope 1.48, Intercept -1.19, Range x 1.2 to 6.6, Range y 0.9 to 7.2, Sy,x 0.247
PT/Fib: n=314, Regression Curve y=1.31x-0.90, Correlation Coefficient 0.9036, Slope 1.31, Intercept -0.90, Range x 1.1 to 6.2, Range y 0.9 to 7.2, Sy,x 0.263
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: Mean Bias for recTP -0.045 or -1.7%, for PTHS+ 0.036 or 1.4%, for PT/Fib -0.062 or -2.3%.
Precision: n=280, Mean INR 2.61, Standard Deviation 0.227, %CV 8.70.
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
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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5.0 510(k) Summary
| Submitted by: | Unipath Ltd
Priory Business Park
Bedford
MK44 3UP
UK
+44 1234 835530
Contact Person: Lesley Moore | NOV 3 0 2007 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Date Prepared: | 30th October 2007 | |
| Device Name: | SmartCheck INRTM System | |
| Classification
Name: | Multipurpose System for in vitro Coagulation Studies
21 CFR Part 864.5425 | |
| Predicate Device: | Roche Diagnostics Corporation CoaguChek® S System cleared
under 510(k) Numbers K020831 and K994349. | |
| Description: | The SmartCheck INRTM system consists of a hand held battery-
powered meter with ROM calibration chip, disposable, dual-
chambered, test strips and high and low level external liquid
controls. When blood is applied to the strip it migrates by capillary
action to the reaction chambers of the strip. The reaction chamber
contains a metallic disc and rabbit brain thromboplastin reagent.
When blood enters the reaction chamber a magnetic field is applied
to the strip to activate disc movement. Upon clot formation, the disc
becomes immobilized and clotting is optically detected. Clotting
time is calculated and displayed as an INR value. | |
| Intended Use: | The SmartCheck INRTM System is intended for quantitative testing
of Prothrombin Time in capillary blood. Results are given in
International Normalized Ratio (INR) units. | |
| Predicate
Comparison: | The SmartCheck INRTM System and the predicate system both
use a hand held meter and disposable strips for the determination of
clotting time in capillary whole blood. The Systems have
comparable test strip reagents and clot detection technology. Both
use external liquid controls. The systems differ in the blood volume
needed to carry out a test, the time to result, strip and ROMkey | |
| Testing and Conclusion: | The SmartCheck INRTM System was evaluated for non-clinical
and clinical performance. SmartCheck INR passed all tests and
correlated favourably to a venous plasma based PT test with respect
to accuracy and precision. A summary of the results is presented
below for combined site calculations and support the conclusion that
the SmartCheck INRTM System is substantially equivalent to the
predicate CoaguChek S System. | |
:
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Accuracy: SmartCheck INR Capillary Blood v. Venous Plasma INR ACL 10000 with recombinant thromboplastin (recTP), PTHS+ reagent and PT/Fibrinogen reagent (PT/Fib).
| Parameter | recTP | PTHS+ | PT/Fib |
|---|---|---|---|
| n | 315 | 310 | 314 |
| Regression Curve | $y = 1.17x - 0.49$ | $y = 1.48x - 1.19$ | $y = 1.31x - 0.90$ |
| Correlation Coefficient | 0.9235 | 0.9009 | 0.9036 |
| Slope | |||
| (95% CI) | 1.17 | ||
| (1.07 to 1.27) | 1.48 | ||
| (1.32 to 1.63) | 1.31 | ||
| (1.21 to 1.42) | |||
| Intercept | |||
| (95% CI) | -0.49 | ||
| (-0.73 to -0.25) | -1.19 | ||
| (-1.57 to -0.81) | -0.90 | ||
| (-1.16 to -0.65) | |||
| Range x | 1.2 to 6.2 | 1.2 to 6.6 | 1.1 to 6.2 |
| Range y | 0.9 to 7.2 | 0.9 to 7.2 | 0.9 to 7.2 |
| Sy,x | 0.250 | 0.247 | 0.263 |
| Mean Bias: Units or % | |||
| (95% CI) | -0.045 or -1.7% | ||
| -0.78 to 0.70 | 0.036 or 1.4% | ||
| -0.87 to 0.94 | -0.062 or -2.3% | ||
| -0.91 to 0.79 |
Precision: SmartCheck INR Capillary Blood Measurement On Duplicate Finger Sticks
| n | 280 |
|---|---|
| Mean INR | 2.61 |
| Standard Deviation | 0.227 |
| %CV | 8.70 |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in all capital letters.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 3 0 2007
Inverness Medical Innovations, Inc. C/O Lesley Moore 51 Sawyer Road Suite 200 Waltham, Massachusetts 02453
Re: K071265
Trade/Device Name: Smartcheck INR System Regulation Number: 21 CFR 864.5425 Regulation Name: Prothrombin Time Test Regulatory Class: Class II Product Code: JPA Dated: May 3, 2007 Received: May 7, 2007
Dear Ms. Moore:
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 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); 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 - Inverness Medical Innovations, Inc.
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 Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,
lole W. Bote
Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology 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): K071265
Device Name: The Inverness Medical Innovations, Inc. SmartCheck INR™ System
Indications For Use: The SmartCheck INR™ System is intended for quantitative testing of Prothrombin Time in capillary blood. Results are given in International Normalized Ratio (INR) units.
The SmartCheck INR System is indicated for use by trained medical professionals in a point of care setting for monitoring the INR of patients on oral anticoagulant therapy.
Prescription Use __ X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 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)
Josephine Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K071265
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