FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100

K063068 · Arkray USA, Inc. · NBW · Dec 20, 2006 · Clinical Chemistry

Device Facts

• Record ID: K063068
• Device Name: FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100
• Applicant: Arkray USA, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 20, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Ferrara 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

System comprises glucose meter, test strips, and control solution; utilizes electrochemical glucose oxidase assay. User inserts test strip into meter; applies capillary blood (fingertip or palm) or control solution. Meter performs 10-second assay; converts electrical current (proportional to glucose concentration) to plasma-equivalent glucose value; displays result on LCD. Used by patients (home) or healthcare professionals (point-of-care). Provides quantitative glucose readings to aid diabetes management. Includes lot-specific calibration via code chip. Labeling warns against palm testing during rapid glucose changes (post-meal, post-insulin, hypoglycemia symptoms).

Clinical Evidence

Clinical study with 106 lay-users and professional testing. Compared palm capillary blood glucose results against professional fingertip reference. Results: Lay-user palm vs. professional finger (n=106) showed 90% in Zone A, 9% in Zone B; Professional palm vs. professional finger (n=109) showed 95% in Zone A, 3% in Zone B. Bias for lay-user palm was 6.2%; professional palm was 1.7%.

Technological Characteristics

Portable, battery-operated glucose meter; uses test strips and control solution. In vitro diagnostic system. No specific materials or ASTM standards provided. Connectivity/software details not specified.

Indications for Use

Indicated for persons with diabetes (home/OTC) or clinical settings for quantitative glucose measurement in fresh capillary whole blood from fingertips 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 (k041881)
• Assure Pro (k053079)

Submission Summary (Full Text)

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K063068

## 5 510(k) Summarv

| 5 510(k) Summary | DEC 2 0 2006 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Arkray USA |
| Contact Person: | Tom Speikers<br>Director, Quality Systems and Regulatory Affairs<br>Arkray USA<br>5182 W. 76th Street<br>Minneapolis, MN 55439<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date Prepared: | October 3, 2006 |
| Trade Name: | Ferrara Blood Glucose Monitoring System |
| Classification: | Glucose test system, 21 CFR 862.1345; Class II |
| Product Codes: | CGA, NBW |
| Predicate Devices: | Advance Micro-draw BGM |
| | Assure Pro BGM |
| Device<br>Description: | The Ferrara Blood Glucose Monitoring System consists of a<br>meter, test strips, and control solution. It is intended for over-<br>the-counter, home use by diabetics to monitor their blood<br>glucose levels, or for use in a clinical setting by health care<br>professionals. The system tests fresh capillary whole blood.<br>The meter is a portable, battery-operated instrument<br>designed for use with Ferrara Blood Glucose Test Strips. |
| Intended Use: | The Ferrara Blood Glucose Monitoring System is intended for<br>the quantitative measurement of glucose in fresh capillary<br>whole blood samples drawn from the fingertips or palm.<br>Testing is done outside the body ( <i>In Vitro</i> diagnostic use). It<br>is indicated for use at home (over the counter [OTC]) by<br>persons with diabetes, or in clinical settings by healthcare<br>professionals, as an aid to monitor the effectiveness of<br>diabetes control. |
| Functional and<br>Safety Testing: | SUMMARY OF TECHNOLOGICAL CHARACTERISTICS |
| | The Ferrara Blood Glucose Monitoring System is technically<br>unchanged by this expansion of indications (claiming palm as<br>sample sites in addition to fingertip testing). The Ferrara<br>system uses a meter substantially equivalent to the<br>"Advance™ Micro-draw" meter with a test strip SE to the<br>Assure Pro test strip. |

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## 1. NON-CLINICAL TESTING

Not Applicable

## 2. CLINICAL TESTING

Accuracy/method comparison testing was done comparing fingertip results obtained by clinicians with alternate site results (palm) results obtained by participants with diabetes.

Testing included both men and women, with both Type 1 and Type 2 diabetes, ages from 20 to 83 years. Tested blood glucose values encompassed the 45-328 mg/dL glucose range. Linear regression statistics, Clarke Error Grid Analysis, and Bias Analysis showed good correlation between fingertip and alternate site results.

- Testing demonstrated that the performance of Ferrara at the Conclusion: palm alternate site was substantially equivalent to that at fingertip.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Tom Speikers Director, Quality Systems and Regulatory Affairs Arkrav USA 5182 W. 76th Street Minneapolis, MN 55439

DEC 2 0 2006

Re: k063068 Trade/Device Name: Ferrara Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: October 03, 2006 Received: October 06, 2006

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 http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper, M.D., M.

Jean M. Cooper, MS. D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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## Indications for Use Statement ব

510(k) Number (if known): K063068

Device Name: Ferrara Blood Glucose Monitoring System

Indications For Use:

Ferrara Blood Glucose Monitoring System:

The Ferrara 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.

Ferrara Blood Glucose Test Strips:

Ferrara Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or palm. Ferrara Test Strips must be used with the Ferrara 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,

Ferrara Control Solution:

For use with Ferrara Blood Glucose Meter and Ferrara Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Prescription Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ ×

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

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