GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System

K142336 · Arkray Factory, Inc. · CGA · Sep 17, 2014 · Clinical Chemistry

Device Facts

• Record ID: K142336
• Device Name: GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System
• Applicant: Arkray Factory, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Sep 17, 2014
• Decision: SESE
• Submission Type: Special
• 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.

Device Story

System comprises blood glucose meter, test strips, and control solution; used by patients with diabetes at home for self-monitoring. Input: fresh capillary whole blood sample applied to test strip. Meter performs electrochemical measurement of glucose concentration; displays quantitative result to user. Output assists patients in tracking diabetes control effectiveness. Modifications in this submission involve changes to exterior meter case materials to support cleaning and disinfection durability. Device is intended for single-patient use.

Clinical Evidence

Bench testing only. Studies included viral elimination effectiveness on meter surfaces, cleaning and disinfection durability testing, drop testing, and button durability studies to validate the robustness of modified exterior materials.

Technological Characteristics

Glucose test system (21 CFR 862.1345). Electrochemical sensing principle. Meter includes modified exterior case materials designed for cleaning and disinfection durability. Standalone device.

Indications for Use

Indicated for single-patient use for blood glucose monitoring.

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 and ReliOn Confirm Blood Glucose Monitoring System (K124021)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing to the right, arranged in a cascading manner. The profiles are connected by a flowing, ribbon-like element. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

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

September 17, 2014

ARKRAY FACTORY INC. LONNA M. DENDOOVEN REGULATORY AFFAIRS SPECIALIST 5182 WEST 76TH STREET EDINA MN 55439

Re: K142336

Trade/Device Name: GLUCOCARD 01 Blood Glucose Monitoring System ReliOn Confirm Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: August 20, 2014 Received: August 21, 2014

Dear Ms. 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 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. 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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/ResourcesforYou/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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## Indications for Use

510(k) Number (if known) k142336

Device Name

The 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) | |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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."

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## Indications for Use

510(k) Number (if known) k142336

Device Name

The 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)

| <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|----------------------------------------------|
| <span></span> | Over-The-Counter Use (21 CFR 801 Subpart C) |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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."

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#### 6 510(k) Summary

| Submitter: | ARKRAY Factory, Inc. |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 1480 Koji, Konan-cho |
| | 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]<br>[e-mail] |
| Date Prepared: | August 20, 2014 |
| 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 and ReliOn<br>Confirm Blood Glucose Monitoring System (K124021) |
| 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 by persons with diabetes as an aid to monitor the effectiveness of<br>diabetes control. It is not intended for the diagnosis of or screening for<br>diabetes mellitus, and is not intended for use on neonates. It is intended<br>for single patient use and should not be shared with other individuals. |
| | The GLUCOCARD 01 SENSOR PLUS Blood Glucose Test Strips are<br>intended to be used with the GLUCOCARD 01 Blood Glucose Meter<br>for the quantitative measurement of glucose in fresh capillary whole<br>blood samples drawn from the fingertips, or palm. |
| | For over the counter use only |
| | 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 by<br>persons with diabetes as an aid to monitor the effectiveness of diabetes |

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| | control. It is not intended for the diagnosis of or screening for diabetes<br>mellitus, and is not intended for use on neonates. It is intended for<br>single patient use and should not be shared with other individuals. |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The ReliOn Confirm Plus Blood Glucose Test Strips are intended to be<br>used with the ReliOn Confirm Blood Glucose Meter for the<br>quantitative measurement of glucose in fresh capillary whole blood<br>samples drawn from the fingertips, or palm. |
| | For over the counter use only |
| Reason for<br>Submission | Modifications to certain exterior materials used in the manufacture of<br>the meter |
| Functional and<br>Safety Testing: | Viral elimination effectiveness studies were conducted on the surfaces<br>of the GLUCOCARD 01 and ReliOn Confirm Meters |
| | Cleaning and disinfection durability testing was performed to<br>demonstrate that the GLUCOCARD 01 and ReliOn Confirm meters<br>can withstand multiple cleaning and disinfection cycles. |
| | Drop testing and button durability studies demonstrate that the material<br>changes do not affect the robustness of the meter case design. |
| Conclusion: | The modified GLUCOCARD 01 and ReliOn Confirm Blood Glucose<br>Monitoring Systems are substantially equivalent to the predicate<br>GLUCOCARD 01 and ReliOn Confirm Blood Glucose Monitoring |