GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM

K063771 · Arkray Factory USA, Inc. · NBW · Aug 9, 2007 · Clinical Chemistry

Device Facts

• Record ID: K063771
• Device Name: GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Arkray Factory USA, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 9, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The GLUCOCARD X-METER Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm or palm. 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.

Device Story

System comprises meter, sensor test strips, and control solutions; used for quantitative glucose measurement in fresh capillary whole blood. Samples obtained from fingertips, forearm, upper arm, or palm. Operated by patients at home or healthcare professionals in clinical settings. Provides blood glucose concentration readings to assist in monitoring diabetes control. Bench testing evaluates interferences, linearity, altitude effects, and analytical precision; clinical testing assesses accuracy for finger stick and alternate site testing. Safety testing includes EMC evaluation.

Clinical Evidence

Clinical testing evaluated accuracy for both finger stick and alternate site testing. Bench testing included evaluation of interferences, linearity, linear range, altitude effects, control solution functionality, and analytical precision. Safety testing included EMC evaluation. Results support substantial equivalence.

Technological Characteristics

Glucose test system (21 CFR 862.1345). Components: meter, sensor test strips, and control solutions (Low, Normal, High). Supports alternate site testing (fingertips, forearm, upper arm, palm).

Indications for Use

Indicated for persons with diabetes (home/OTC) or clinical settings (healthcare professionals) for quantitative measurement of glucose in fresh capillary whole blood from fingertips, forearm, upper arm, or palm to monitor diabetes control effectiveness.

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

• Hypoguard Advance Micro-draw Blood Glucose Meter (k041881)

Submission Summary (Full Text)

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K06377/

AUG - 9 2007

## 5 510(k) Summary

| Submitter: | ARKRAY Factory USA |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tom Speikers<br>Director, Quality Systems and Regulatory Affairs<br>ARKRAY Factory USA, Inc.<br>5182 W. 76th Street<br>Minneapolis, MN 55439<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date Prepared: | December 11, 2006 |
| Trade Name: | GLUCOCARD X-METER Blood Glucose Monitoring System |
| Classification: | Glucose test system, 21 CFR 862.1345; Class II |
| Product Codes: | CGA, NBW, JJX |
| Predicate Device: | Advance Micro-draw BGM |
| Device<br>Description: | The GLUCOCARD X-METER Blood Glucose Monitoring System<br>consists of a meter, sensor test strips, and control solutions for<br>use as an aid to monitor the effectiveness of diabetes control. |
| Intended Use: | The GLUCOCARD X-METER Blood Glucose Monitoring System<br>is intended for the quantitative measurement of glucose in fresh<br>capillary whole blood samples drawn from the fingertips,<br>forearm, upper arm or palm. Testing is done outside the body<br>(In Vitro diagnostic use). It is indicated for use at home (over the<br>counter [OTC]) by persons with diabetes, or in clinical settings by<br>healthcare professionals, as an aid to monitor the effectiveness<br>of diabetes control. |
| Functional and<br>Safety Testing: | A full array of in-house and clinical testing was done consistent<br>with relevant FDA guidances for blood glucose monitoring<br>systems.<br><br>Bench testing included evaluation of interferences, linearity,<br>linear range, altitude effects, control solution functionality, and<br>analytical precision.<br><br>Clinical testing included evaluation of accuracy for both finger<br>stick and Alternate Site Testing.<br><br>Safety testing included evaluation of EMC. |
| Conclusion: | Labeling, bench testing results and clinical testing results support<br>the Indications for Use and the claim of substantial equivalence<br>to the predicate. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

AUG - 9 2007

Arkray Factory USA, Inc. c/o Mr. Tom Speikers Director, Quality Systems & Regulatory Affairs 5182 W. 76th Street Minneapolis, MN 55439

Re: k063771

Trade Name: GlucocardX-Meter Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, LFR, JJX Dated: July 06, 2007 Received: July 10, 2007

Dear Mr. Speikers:

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).

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This letter 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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). 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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Cooper, M.S., D.V.M.

Yéan M. Cooper, M.S., D.V.M. 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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## Indications for Use Statement

510(k) Number (if known): K063771

Device Name: GLUCOCARD X-METER Blood Glucose Monitoring System

Indications For Use:

GLUCOCARD X-METER Blood Glucose Monitoring System:

The GLUCOCARD X-METER Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm or palm. 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.

## GLUCOCARD X-METER:

The GLUCOCARD X-METER is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm or palm. GLUCOCARD X-SENSOR Blood Glucose Test Strips must be used with the GLUCOCARD X-METER. 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.

GLUCOCARD X-SENSOR Blood Glucose Test Strips:

GLUCOCARD X-SENSOR Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm or paim. GLUCOCARD X-SENSOR Blood Glucose Test Strips must be used with the GLUCOCARD X-METER Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are 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.

## GLUCOCARD X-METER CONTROL:

For use with GLUCOCARD X-METER Blood Glucose Meter and GIJUCOCARD X-SENSOR Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. Control solutions are available in three levels - Low (L), Normal (N) and High (H).

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use × AND/OR (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 (OIVD)

Carol C. Benam
Division Sign-Off

Evaluation and Sa

K063771