GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110

K082417 · Arkray Factory USA, Inc. · CGA · Oct 21, 2008 · Clinical Chemistry

Device Facts

• Record ID: K082417
• Device Name: GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110
• Applicant: Arkray Factory USA, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Oct 21, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The GLUCOCARD™ 01-mini 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 (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

GLUCOCARD™ 01-mini is a blood glucose monitoring system comprising a meter, test strips, and control solutions. It measures glucose levels in fresh capillary whole blood samples obtained from fingertips or palms. Used by patients at home or healthcare professionals in clinical settings, the device provides quantitative glucose readings to assist in diabetes management. The system functions as an in vitro diagnostic tool; it processes blood samples to provide immediate feedback on glucose concentration, enabling users to monitor the effectiveness of their diabetes control strategies.

Clinical Evidence

Clinical study conducted with persons with diabetes to evaluate system accuracy and ease of use. Analytical verification testing performed to evaluate precision, dynamic range, and linearity.

Technological Characteristics

System includes meter, test strips, and control solutions. Quantitative measurement of glucose in capillary whole blood. In vitro diagnostic device. Class II, 21 CFR 862.1345.

Indications for Use

Indicated for use by patients with diabetes for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip, palm, or forearm.

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

• Arkray Glucocard 01 (K073416)

Submission Summary (Full Text)

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## OCT 2 1 2008

| Submitter: | ARKRAY Factory USA, Inc<br>Est. Number: 1832816<br>Owner/Operator Number: 8030316 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | August 20, 2008 |
| Trade Name: | GLUCOCARD™ 01-mini Blood Glucose Monitoring System |
| Classification: | Glucose test system, 21 CFR 862.1345, Class II |
| Product Codes: | CGA, NBW, JJX |
| Predicate Device: | ARKRAY GLUCOCARD™ 01 Blood Glucose Monitoring System |
| Device Description: | GLUCOCARD™ 01-mini consists of a meter, test strips, and control solutions for use in measuring blood glucose as an aid to monitor the effectiveness of diabetes control. |
| Intended Use: | The GLUCOCARD™ 01-mini 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 ( <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. |
| Functional and Safety Testing: | A clinical study was done with persons with diabetes to evaluate system accuracy and to assess ease of use.<br>Analytical verification testing was performed to evaluate precision, dynamic range and linearity. |
| Conclusion: | The modified GLUCOCARD™ 01-mini Blood Glucose Monitoring System is substantially equivalent to the predicate GLUCOCARD™ 01 Blood Glucose Monitoring System. |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

OCT 2 1 2008

K082417 Re:

> Trade/Device Name: GLUCOCARD™ 01-mini Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: CGA, NBW, JJX Dated: September 18, 2008 Received: September 22, 2008

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 frea mober [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

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

Sean 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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## 5 Indications for Use Statement

510(k) Number (if known):

): K082917

Device Name: ARKRAY GLUCOCARD™ 01-mini Blood Glucose Monitoring System

Indication For Use:

## GLUCOCARD™ 01-mini Blood Glucose Monitoring System:

The GLUCOCARD™ 01-mini 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 (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.

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)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K082417

CONFIDENTIAL