ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM

K124021 · Arkray Factory, Inc. · CGA · Jun 30, 2014 · Clinical Chemistry

Device Facts

• Record ID: K124021
• Device Name: ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Arkray Factory, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Jun 30, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The GLUCOCARD 01 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended for single patient use and should not be shared with other individuals. The GLUCOCARD 01 SENSOR PLUS Blood Glucose Test Strips are intended to be used with the GLUCOCARD 01 Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. The ReliOn Confirm Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended for single patient use and should not be shared with other individuals. The ReliOn Confirm Plus Blood Glucose Test Strips are intended to be used with the ReliOn Confirm Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm.

Device Story

System measures capillary whole blood glucose via amperometric assay; uses glucose oxidase and hexaammineruthenium (III) chloride chemistry on test strips. User applies 0.3μL blood sample to strip; capillary action draws sample into tip. Meter detects current generated by oxidation of hexaammineruthenium (II) chloride; converts current to glucose concentration. Used at home by patients with diabetes; provides quantitative results to aid monitoring of diabetes control. Modification involves test strip electrode pattern, capillary gate size, and logo layers. Meter hardware/software unchanged from predicate. Includes validated cleaning/disinfection instructions for single-patient use.

Clinical Evidence

Clinical study conducted with persons with diabetes to evaluate system accuracy and ease of use. Analytical verification testing performed for precision, linearity, interfering substances, sample volume, stability, altitude, hematocrit, and environmental conditions.

Technological Characteristics

Electrochemical glucose test system. Consists of meter, test strips, and control solution. No changes to meter hardware or software from predicate. Manufacturing process for test strips modified for efficiency.

Indications for Use

Indicated for home use by persons with diabetes to monitor glucose levels in fresh capillary whole blood from fingertips or palm. Not for neonates, diagnosis, or screening of diabetes.

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

• GLUCOCARD 01 Blood Glucose Monitoring System (K073416)

Submission Summary (Full Text)

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#### 5 510(k) Summary

JUN 3 0 2014

| Submitter: | ARKRAY Factory, Inc.<br>1480 Koji, Konan-cho<br>Koka-shi, Shiga, JAPAN, 520-3306 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lonna M. DenDooven<br>Regulatory Affairs Specialist<br>ARKRAY Factory USA, Inc.<br>5182 West 76th Street<br>Edina, Minnesota, USA 55439<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | June 30, 2013 |
| Trade Name: | GLUCOCARD 01 Blood Glucose Monitoring System<br>ReliOn Confirm Blood Glucose Monitoring System |
| Classification: | Glucose test system, 21 CFR 862.1345; Class II |
| Product Codes: | CGA, NBW |
| Predicate Device: | GLUCOCARD 01 Blood Glucose Monitoring System (K073416) |
| Device Description: | The GLUCOCARD 01 Blood Glucose Monitoring System and ReliOn<br>Confirm Blood Glucose Monitoring System consist of a meter, test<br>strips, and control solution for use as an aid to monitor the effectiveness<br>of diabetes control. |
| Intended Use: | The GLUCOCARD 01 Blood Glucose Monitoring System is intended<br>for the quantitative measurement of glucose in fresh capillary whole<br>blood samples drawn from the fingertips, or palm. Testing is done<br>outside the body (In Vitro diagnostic use). It is indicated for use at<br>home (over the counter [OTC]) by persons with diabetes as an aid to<br>monitor the effectiveness of diabetes control. It is not intended for the<br>diagnosis of or screening for diabetes mellitus, and is not intended for<br>use on neonates. It is intended for single patient use and should not be<br>shared with other individuals.<br><br>The ReliOn Confirm Blood Glucose Monitoring System is intended for<br>the quantitative measurement of glucose in fresh capillary whole blood<br>samples drawn from the fingertips, or palm. Testing is done outside the<br>body (In Vitro diagnostic use). It is indicated for use at home (over the<br>counter [OTC]) by persons with diabetes as an aid to monitor the<br>effectiveness of diabetes control. It is not intended for the diagnosis of<br>or screening for diabetes mellitus, and is not intended for use on<br>neonates. It is intended for single patient use and should not be shared<br>with other individuals. |

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| Substantial<br>Equivalence Basis: | The new GLUCOCARD 01 Blood Glucose Monitoring System is<br>identical to the GLUCOCARD 01 (k073416, cleared by FDA June 13,<br>2008) except that the manufacturing process for the GLUCOCARD 01<br>SENSOR Blood Glucose Test Strip has been modified to allow for<br>more efficient production. The fundamental scientific technology of the<br>modified test strip has not changed. The modifications to the test strip<br>did not require any changes to meter hardware, software or other<br>components of the test system. |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Functional and<br>Safety Testing: | A clinical study was conducted with persons with diabetes to evaluate<br>system accuracy and to assess ease of use.<br><br>Analytical verification testing was performed to evaluate precision,<br>dynamic range/linearity, interfering substances, sample volume,<br>stability and the effect of altitude, hematocrit, and environmental<br>conditions. |
| Conclusion: | Labeling, bench testing results and clinical testing results support the<br>Indications for Use and the claim of substantial equivalence to the<br>predicate. |

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the department's name around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a person with outstretched arms, composed of three curved lines.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

ARKRAY FACTORY INC. LONNA DENDOOVEN REGULATORY AFFAIRS SPECIALIST 2198 WEST 76TH ST EDINA MN 55439

June 30, 2014

Re: K124021

Trade/Device Name: ARKRAY GLUCOCARD™ 01 Blood Glucose Monitoring System ReliOn Confirm Blood Glucose Monitoring

Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW.CGA Dated: June 18. 2014 Received: June 19, 2014

Dear Ms. Lonna Dendooven:

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 reclassilied 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. Ilsuing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. 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 complics 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Ms. Dendooven

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809). please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

## Katherine Serrano -S

For: Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) k 12402 1

#### Device Name

GLUCOCARD 01 Blood Glucose Monitoring System

#### Indications for Use (Describe)

The GLUCOCARD 01 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended for single patient use and should not be shared with other individuals.

The GLUCOCARD 01 SENSOR Plus Blood Glucose Test Strips are intended to be used with the GLUCOCARD 01 Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

:

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Stayce Beck -S

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) k 124021

#### Device Name

ReliOn Confirm Blood Glucose Monitoring System

#### Indications for Use (Describe)

The ReliOn Confirm Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended for single patient use and should not be shared with other individuals.

The ReliOn Confirm Plus Blood Glucose Test Strips are intended to be used with the ReliOn Confirm Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Stayce Beck -S

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

. , ,