EASY CHECK BLOOD GLUCOSE MONITORING SYSTEM

K062538 · Diacare Corp. · NBW · Apr 30, 2007 · Clinical Chemistry

Device Facts

• Record ID: K062538
• Device Name: EASY CHECK BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Diacare Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The EASY CHECK Blood Glucose Monitoring Systems is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the following alternative sites: the palm and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and healthcare facilities as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Device Story

System measures glucose in capillary whole blood via amperometric technology; utilizes glucose oxidase enzyme on carbon electrodes. User applies blood sample to test strip; meter measures electrical current generated by glucose-enzyme reaction; correlates current to glucose concentration. Used by healthcare professionals and patients at home. Requires lot-specific code card matching test strip vial. Output displayed on meter screen; aids in monitoring diabetes control programs. Alternative site testing (palm/forearm) restricted to steady-state glucose conditions. System includes meter, test strips, control solutions, and lancets.

Clinical Evidence

Method comparison study with 260 patients; compared EASY CHECK system against YSI reference analyzer and predicate device. Results showed high correlation (r^2=0.9734 vs YSI). Accuracy met ISO 15197:2003 requirements: 100% of results <75 mg/dL within 15 mg/dL of lab; 95% of results ≥75 mg/dL within 20% of lab. Precision study (n=10 meters, 20 days) showed %CV between 3.7% and 6.8%.

Technological Characteristics

Amperometric sensing; glucose oxidase enzyme; carbon electrodes. 3V lithium battery (CR2032) power. Dimensions: 58x80x19 mm. Connectivity: Code card for lot-specific calibration. Traceable to NIST SRM 917b. Operating range: 10-40°C; 20-80% humidity. Sample volume: 1.5 µL. Test range: 30-600 mg/dL.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood (finger, palm, forearm) for healthcare professionals and patients with diabetes mellitus to monitor diabetes control programs. Not for neonates, diagnosis, or screening.

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

• Bayer Elite Diabetes Care System (k043311)
• Bayer Ascensia Microfill Control (k023657)

Submission Summary (Full Text)

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Exhibit 3a
K062538

# DIACARE CORP.

APR 3 0 2007

4977 E. La Palma Ave. Anaheim, CA 92807 Tel:[phone]

# 510(k) Summary

# Administrative Information and Device Identification

| Name and address of sponsor of the 510(k) submission: | Diacare Corp.<br>4977 E. LA PALMA AVE.<br>ANAHEIM, CA 92807 |
|-------------------------------------------------------|--------------------------------------------------------------------------------|
| Official contact person for all correspondence: | Calvin Chang, [e-mail]<br>Phone: [phone]; Fax: [phone] |
| Date Prepared: | August 21, 2006 |
| Device Name: | EASY CHECK Blood Glucose Monitoring<br>System |
| Generic name of the device: | Blood Glucose Meter |
| Classification of new device: | Class II |
| Classification Panel: | Clinical Chemistry and Toxicology |
| Product Code and CFR Regulation Number: | NBW, CGA and 21 CFR 862.1345 |
| Predicate Device Name and 510(k) Number: | ASCENSIA ELITE DIABETES CARE SYSTEM<br>k043311 |

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#### Description of Device:

The EASY CHECK Blood Glucose Monitoring System is designed to provide an easy, accurate method for determining capillary blood glucose values. This analysis is based on amperometric technology using glucose oxidase that is specific for the blood glucose measurement. When the blood sample is applied to the test strip, electrons are formed by the reaction between glucose oxidase and blood glucose. The electrical current is measured by the meter and correlates with the concentration of glucose in the blood sample.

The EASY CHECK Blood Glucose Monitoring System consists of the Meter, Test strips with instructions, Lancing device with instructions, Lancets, Code card, 3-Volt Lithium Coin Battery, Users Guide, Log Book, Carrying case and EASY CHECK Control Solutions (level 1 and level 2)

#### Comparison of Device Technological Characteristics to Predicate Device:

EASY CHECK Blood Glucose Monitoring System and ASCENSIA ELITE DIABETES CARE SYSTEM are similar in many respects. Among other similarities, they use the same detection method, enzyme, mediator and basic electrode material.

Differences include the Hematocrit range, temperature range, test time and sample volume. Tests included in this 510(k) submission have incorporated these changes and results show that they introduce no new questions on the safety and effectiveness of the EASY CHECK Blood Glucose Monitoring System.

| Item | Device | Predicate |
|---------------------|----------------------------|----------------------------|
| | Easycheck | Bayer Elite |
| Detection<br>Method | Amperometry | Amperometry |
| Enzyme | Glucose Oxidase | Glucose Oxidase |
| Mediator | Potassium Hexacyanoferrate | Potassium Hexacyanoferrate |
| Electrode | Carbon | Carbon |
| Coding | Code key | Code Key |
| Sample type | whole blood | whole blood |
| Humidity | 20%-80% | 20%-80% |

#### Similarities:

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| Power Supply | 3V lithium battery (CR2032) | 3V lithium battery (CR2032) |
|------------------|-----------------------------|-----------------------------|
| Battery lifetime | Over 1000 tests | Over 1000 tests |
| Weight | 50 g | 50 g |

Differences:

| Temp. Range | 2-30 □<br>36-86 □ | 15-30 □<br>60-86 □ |
|--------------------|-----------------------------|--------------------|
| Hct Range | 30%-50% | 20%-60% |
| Test Range | 30-600 mg/dL | 20-600 mg/dL |
| Test time | 9 second | 30 second |
| Sample volume | 1.5 μL | 3 μL |
| Test sample | fingertip, palm and forearm | fingertip |
| Memory | 180 sets | 20 sets |
| Meter<br>dimension | 58x80x19 mm | 81x51x14 mm |

## Intended Use:

The EASY CHECK Blood Glucose Monitoring Systems is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the following alternative sites: the palm and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and healthcare facilities as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

#### Non-Clinical Testing:

Sensitivity, precision, linearity and other tests were used to demonstrate the performance and reliability of EASY CHECK Blood Glucose Monitoring System. Meter also passed appropriate EMC requirements.

## Clinical Testing:

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Consumer (field) testing was done to prove that the EASY CHECK Blood Glucose Monitoring System is easy to use by lay people and also that test results are accurate and comparable to a laboratory reference method and to the predicate device.

## Conclusion:

Detailed testing has confirmed that the EASY CHECK Blood Glucose Monitoring System is substantially equivalent to the predicate device and that the differences do not bring up any new safety or effectiveness concerns.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Diacare Corp. c/o Mr. Sid Mathur MDI Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021

APR 3 0 2007

k062538 Re:

> Trade/Device Name: Easy Check Blood Glucose Monitoring System and Easy Check Glucose Control Solution Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: April 2, 2007 Received: April 3, 2007

Dear Mr. Mathur:

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), and 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.

Jean 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

#### 510(k) Number (if known): K062538

#### Device Name: EASY CHECK Blood Glucose Monitoring System

Indications for Use: The EASY CHECK Blood Glucose Monitoring Systems is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the following alternative sites: the palm and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and healthcare facilities as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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

CFC

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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SK062538

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#### Indications for Use

510(k) Number (if known): K062538

#### Device Name: EASY CHECK Glucose Control Solution

Indications for Use: The EASY CHECK Control Solution is intended for in vitro diagnostic use by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the EASY CHECK Blood Glucose Monitor System.

Prescription Use ﺴﮯ (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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

tion Sign-Off

Affice of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of 1