EZ SMART

K043340 · Vip Diagnostics, LLC · NBW · Jun 2, 2005 · Clinical Chemistry

Device Facts

• Record ID: K043340
• Device Name: EZ SMART
• Applicant: Vip Diagnostics, LLC
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 2, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The EZ Smart Blood Glucose Test Strips are used with the EZ Smart Meter to measure Glucose (sugar) in the whole blood. The EZ Smart Test strips are for testing outside the body (in vitro diagnostic use). The EZ Smart Blood Glucose Monitoring System is intended for use in the home and in the professional settings to monitor blood glucose levels for better glucose level control among diabetics. The EZ Smart Blood Glucose Monitoring System is indicated for use with capillary whole blood samples drawn from the fingertips and forearm.

Device Story

System uses electrochemical biosensor technology to measure glucose in fresh capillary whole blood. User applies blood drop to test strip; glucose oxidase enzyme triggers chemical reaction producing current; meter measures current to calculate glucose concentration. Results displayed in 10 seconds. Used in home or professional settings by patients or clinicians. Provides quantitative glucose values (20-600 mg/dL) to assist in diabetes management and glucose control. No physical changes from predicate; submission adds alternative site testing (forearm) capability.

Clinical Evidence

No clinical data provided; bench testing only. The submission relies on the established performance characteristics of the predicate device, with modifications limited to labeling.

Technological Characteristics

Glucose test system (21 CFR 862.1345). System consists of a meter and test strips for in vitro diagnostic use. No changes to materials, sensing principles, or energy sources were reported.

Indications for Use

Indicated for diabetics to monitor blood glucose levels using capillary whole blood from fingertips or forearm. Not for use during rapid glucose changes (e.g., post-meal, post-insulin, post-exercise) or when hypoglycemia is suspected.

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

• VIP Diagnostics EZ Smart Blood Glucose Monitoring System (k040848)

Submission Summary (Full Text)

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K093340

# 510(k) Summary

for

# EZ Smart Blood Glucose Monitoring System New 510(k) For Additional Labeling And Indication For Alternative Site Testing

## 1. DATE PREPARED

December 3, 2004

# 2. SPONSOR INFORMATION

Address

VIP Diagnostics LLC 1796 Clove Road Staten Island, NY 10304

Contact Person: George P. Drogaris, MS R.Ph.

[phone] (telephone) [phone] (facsimile)

Outside Regulatory Counsel

Foley & Lardner LLP 3000 K St., NW Suite 500 Washington, DC 20007

Contact Person: David L. Rosen, B.S.Pharm., J.D.

[phone] (telephone) [phone] (facsimile)

## 3. DEVICE NAME

| Proprietary Name: | EZ Smart Blood Glucose Monitoring System |
|----------------------|------------------------------------------------------|
| Common/Usual Name: | Blood Glucose Monitoring System |
| Classification Name: | Glucose Test System (per 21 C.F.R § 862.1345 (2003)) |

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# 4. DEVICE DESCRIPTION AND INTENDED USE

The EZ Smart Blood Glucose Test Strips are used with the EZ Smart Meter to measure Glucose (sugar) in whole blood. The EZ Smart Test strips are for testing outside the body (in vitro diagnostic use ). The EZ Smart Blood Glucose Monitoring System is intended for use in the home and in the professional settings to monitor blood glucose levels for better glucose level control among diabetics.

The EZ Smart Blood Glucose Monitoring System is indicated for use with capillary whole blood samples drawn from the fingertip and forearm.

#### 5. PREDICATE DEVICE

- Predicate device name 1.
EZ Smart Blood Glucose Monitoring System Bayer Elite XL with the Elite Test Strips Baver Elite with the Elite Test Strips

- Predicate K Number 2.
K040848 (EZ Smart) K984006 (Bayer Elite XL) K964630 (Bayer Elite) K991242 (Bayer Elite Test Strips)

- Substantial Equivalence Comparison 3.
The modifications to the device encompass labeling changes only. There has been no changed to the intended use, fundamental scientific technology, physical design, operating principles, functionality or material composition of the device systems.

# Modified labeling additions to EZ Smart:

Note: Alternative Site Testing Note: Incential.re brofessional prior to testing from a site other than vour fingertips.

Under certain conditions, blood glucose testing results from sites other than your fingertip may be significantly different. These differences may vary from

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individual to individual, and are physiological differences caused by factors such as food intake, health state and medication being used.

The conditions in which these differences are more likely to occur are when your I the conditions in maging rapidly such as following a meal, an insulin dose, or associated with physical exercise. When blood glucose is changing rapidly, associated with piry creat ense changes more quickly than other sample sites.

Use alternative test sites only for testing prior to, or more than two hours after meals, insulin dose, or physical exercise.

You should also use fingertip testing whenever you have a concern about 1 ou should also ass in relations) such as when driving a car, particularly if you nypog.fyouma (insuceness, as alternative site testing may fail to detect hypoglycemia.

If you perform testing other than from a fingertip (such as the forearm):

A. Select a soft, fleshy area of skin that is free from hair and visible veins.

B. Wash the puncture site with soap and warm water. Rinse and dry thoroughly. This ensures cleanliness and increases blood flow to the puncture site.

C. After you have determined the proper depth of your selected site, set the lancing device for that depth of puncture. Firmly press the lancing device against the skin at the selected lancing site, then press the button to lance the skin. When the skin at the belows on the surface of your skin, bring the meter and test strip up to touch the drop.

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#### PERFORMANCE CHARACTERISTIC SUMMARY 6.

There has been no change to the performance characteristics of the device system.

#### TECHNOLOGICAL CHARACTERISTICS 7.

There has been no changes to the fundamental scientific technology.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized symbol. The symbol is a stylized representation of a human figure embracing a globe, symbolizing the department's mission to protect the health of all Americans and provide essential human services.

JUN 2 - 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

VIP International Wholesales, Corp. c/o David L. Rosen, B.S. Pharm., J.D. Foley & Lardner LLP 3000 K Street, NW, Suite 500 Washington, DC 20007-5143

Re: k043340

Trade/Device Name: EZ Smart Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: April 11, 2005 Received: April 11, 2005

Dear Mr. Rosen:

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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## Page 2 -

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/industry/support/index.html.

Sincerely yours,

Carol C. Benam

Carol C. Benson, M.A. Acting 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: | K 043340 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | EZ Smart Blood Glucose Monitoring System |
| Indications For Use: | The EZ Smart Blood Glucose Test Strips are used with the EZ Smart Meter to measure Glucose (sugar) in the whole blood. The EZ Smart Test strips are for testing outside the body (in vitro diagnostic use). The EZ Smart Blood Glucose Monitoring System is intended for use in the home and in the professional settings to monitor blood glucose levels for better glucose level control among diabetics. The EZ Smart Blood Glucose Monitoring System is indicated for use with capillary whole blood samples drawn from the fingertips and forearm. |

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

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 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)

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