ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM

K092104 · Arkray Factory USA, Inc. · CGA · Nov 24, 2009 · Clinical Chemistry

Device Facts

• Record ID: K092104
• Device Name: ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Arkray Factory USA, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Nov 24, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Assure Platinum Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. The Assure Platinum Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Device Story

System uses biosensor technology to measure glucose in capillary whole blood. User applies blood sample to test strip; glucose reacts with glucose oxidase and Hexaamineruthenium (III) chloride, generating electric current proportional to glucose concentration. Meter converts current to glucose value. Used at home by patients or in clinical settings by professionals. Auto-coding feature eliminates manual calibration. Provides quantitative glucose results to aid diabetes management. Includes quality control solutions to verify system accuracy.

Clinical Evidence

Clinical testing evaluated accuracy of finger stick measurements. Bench testing included evaluation of interferences, dynamic range, linearity, hematocrit effects, altitude effects, control solution functionality, and analytical precision. Results supported substantial equivalence.

Technological Characteristics

System uses electrochemical sensing principle. Components include meter, test strips, and control solution (Normal/High). Operates on fresh capillary whole blood. Designed for OTC and clinical use. Bench testing performed per FDA guidance for glucose monitoring systems.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood from fingertips. For use by persons with diabetes (OTC) or healthcare professionals in clinical settings to monitor diabetes control. Contraindicated for neonates and not for diabetes diagnosis or screening.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Assure Pro (k053079)

Submission Summary (Full Text)

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## K092104 510(k) Summary 7

| Submitter: | ARKRAY Factory USA, Inc. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 5182 W. 76th Street |
| | Minneapolis, MN 55439 |
| | |
| Contact Person: | Hamid Idrissi |
| | Regulatory Affairs Project Manager |
| | ARKRAY Factory USA, Inc. |
| | 5182 W. 76th Street |
| | Minneapolis, MN 55439 |
| | Phone: [phone] |
| | Fax: [phone]<br>[e-mail] |
| Date Prepared: | July 10, 2009 |
| Trade Name: | Assure Platinum Blood Glucose Monitoring System |
| Classification: | Glucose test system, 21 CFR 862.1345 and 862.1660; Class II |
| Product Codes: | CGA, NBW, JJX |
| Predicate Device: | Assure Pro (k053079) |
| Device Description: | The Assure Platinum Blood Glucose Monitoring System consist of a |
| | meter, test strips, and control solution for use as an aid to monitor the |
| | effectiveness of diabetes control. |
| Intended Use: | The Assure Platinum Blood Glucose Monitoring Systems is intended |
| | for the quantitative measurement of glucose in fresh capillary whole |
| | blood samples drawn from the fingertips. Testing is done outside the<br>body ( <i>In Vitro</i> diagnostic use). It is indicated for use at home (over the |
| | counter [OTC]) by persons with diabetes, or in clinical settings by |
| | healthcare professionals, as an aid to monitor the effectiveness of |
| | diabetes control. |
| | The Assure Platinum Blood Glucose Monitoring System is not intended |
| | for the diagnosis of or screening for diabetes mellitus, and is not<br>intended for use on neonates. |
| Functional and<br>Safety Testing: | A full array of in-house and clinical testing was done consistent with |
| | relevant FDA guidance's for blood glucose monitoring systems. |
| | Bench testing included evaluation of interferences, Dynamic range and |
| | linearity, hematocrit effects, altitude effects, control solution |
| | functionality, and analytical precision. |
| | Clinical testing included evaluation of accuracy for finger stick for<br>Assure Platinum. |
| Conclusion: | Labeling, bench testing results and clinical testing results support the<br>Indications for Use and the claim of substantial equivalence to the |
| | predicate. |

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PreMarket Notification: Assure Platinum Blood Glucose Monitoring System

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Image /page/1/Picture/1 description: The image shows a logo with two distinct parts. On the left, there's a circular arrangement of text that reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES'. To the right of the text, there's a stylized graphic consisting of three curved, parallel lines that resemble a fluid or flowing shape. The logo is presented in black and white.

NOV 2 4 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Arkray Factory USA, Inc. c/o Mr. Hamid Idrissi Regulatory Affairs Project Manager 5182 W. 76th Street Minneapolis, MN 55439

Re: k092104

> Trade Name: Assure Platinum Blood Glucoses Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: CGA, NBW, JJX Dated: November 04, 2009 Received: November 16, 2009

'Dear Mr. Idrissi:

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); 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).

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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" (21 CFR 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 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 [phone] or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

CA

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## 6 Indications for Use Statement

510(k) Number (if known):

Device Name: Assure Platinum Blood Glucose Monitoring System

Indications For Use:

Assure Platinum Blood Glucose Monitoring System:

The Assure Platinum Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

The Assure Platinum Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Assure Platinum Blood Glucose Meter:

The Assure Platinum Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

Assure Platinum Blood Glucose Test Strips:

Assure Platinum test strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips when used with the Assure Platinum Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use in home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

Assure Dose CONTROL:

For use with Assure Platinum Blood Glucose Meter and Assure Platinum Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. Control solutions are available in two levels - Normal (Level 1) and High (Level 2).

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices Evaluation and Safety (OIVD)

Carol Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safe 510(k)