SMARTCHECK INR SYSTEM

K071265 · Inverness Medical Innovations, Inc. · JPA · Nov 30, 2007 · Hematology

Device Facts

• Record ID: K071265
• Device Name: SMARTCHECK INR SYSTEM
• Applicant: Inverness Medical Innovations, Inc.
• Product Code: JPA · Hematology
• Decision Date: Nov 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The SmartCheck INR™ System is intended for quantitative testing of Prothrombin Time in capillary blood. Results are given in International Normalize Ratio (INR) units. The SmartCheck™ INR System is indicated for used by trained medical professionals in a point of care setting for monitoring the INR of patients on oral anticoagulant therapy.

Device Story

System comprises handheld battery-powered meter, ROM calibration chip, and disposable dual-chambered test strips; utilizes rabbit brain thromboplastin reagent. Input: capillary blood sample applied to test strip. Operation: blood migrates via capillary action to reaction chambers containing metallic discs; magnetic field activates disc movement; clot formation immobilizes discs; optical sensors detect disc cessation. Meter calculates clotting time and converts to INR. Used in point-of-care settings by trained medical professionals. Output: INR result displayed on meter. Benefits: rapid, quantitative INR monitoring for anticoagulation therapy management.

Clinical Evidence

Method comparison study conducted at three sites comparing SmartCheck INR results to ACL 1000 laboratory analyzer using three different reagents (recTP, PTHS, PT/FIB). N=310-315 samples. Orthogonal regression showed slopes ranging from 1.04 to 1.57 and R-values 0.89-0.93. Precision study (EP5-A2) showed 8.7% CV in patient samples. Normal range established in 118 healthy subjects (0.8-1.3 INR). Sensitivity to coagulation factors II, V, VII, and X confirmed.

Technological Characteristics

Handheld, battery-powered meter. Sensing principle: optical detection of metallic disc immobilization in a magnetic field. Reagent: rabbit brain thromboplastin. Connectivity: ROM calibration chip. Form factor: handheld.

Indications for Use

Indicated for trained medical professionals to monitor INR in patients on oral anticoagulant therapy using capillary blood.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Roche Diagnostics Corporation CoaguChek® S System (k020831, k994349)

Submission Summary (Full Text)

{0}------------------------------------------------

K071265

## 5.0 510(k) Summary

| Submitted by: | Unipath Ltd<br>Priory Business Park<br>Bedford<br>MK44 3UP<br>UK<br>[phone]<br>Contact Person: Lesley Moore | NOV 3 0 2007 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Date Prepared: | 30th October 2007 | |
| Device Name: | SmartCheck INRTM System | |
| Classification<br>Name: | Multipurpose System for <i>in vitro</i> Coagulation Studies<br>21 CFR Part 864.5425 | |
| Predicate Device: | Roche Diagnostics Corporation CoaguChek® S System cleared<br>under 510(k) Numbers k020831 and k994349. | |
| Description: | The SmartCheck INRTM system consists of a hand held battery-<br>powered meter with ROM calibration chip, disposable, dual-<br>chambered, test strips and high and low level external liquid<br>controls. When blood is applied to the strip it migrates by capillary<br>action to the reaction chambers of the strip. The reaction chamber<br>contains a metallic disc and rabbit brain thromboplastin reagent.<br>When blood enters the reaction chamber a magnetic field is applied<br>to the strip to activate disc movement. Upon clot formation, the disc<br>becomes immobilized and clotting is optically detected. Clotting<br>time is calculated and displayed as an INR value. | |
| Intended Use: | The SmartCheck INRTM System is intended for quantitative testing<br>of Prothrombin Time in capillary blood. Results are given in<br>International Normalized Ratio (INR) units. | |
| Predicate<br>Comparison: | The SmartCheck INRTM System and the predicate system both<br>use a hand held meter and disposable strips for the determination of<br>clotting time in capillary whole blood. The Systems have<br>comparable test strip reagents and clot detection technology. Both<br>use external liquid controls. The systems differ in the blood volume<br>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<br>and clinical performance. SmartCheck INR passed all tests and<br>correlated favourably to a venous plasma based PT test with respect<br>to accuracy and precision. A summary of the results is presented<br>below for combined site calculations and support the conclusion that<br>the SmartCheck INRTM System is substantially equivalent to the<br>predicate CoaguChek S System. | |

:

{1}------------------------------------------------

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<br>(95% CI) | 1.17<br>(1.07 to 1.27) | 1.48<br>(1.32 to 1.63) | 1.31<br>(1.21 to 1.42) |
| Intercept<br>(95% CI) | -0.49<br>(-0.73 to -0.25) | -1.19<br>(-1.57 to -0.81) | -0.90<br>(-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 %<br>(95% CI) | -0.045 or -1.7%<br>-0.78 to 0.70 | 0.036 or 1.4%<br>-0.87 to 0.94 | -0.062 or -2.3%<br>-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 |

{2}------------------------------------------------

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

{3}------------------------------------------------

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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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

{4}------------------------------------------------

## 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

Page 1 of