EZ SMART

K040848 · Vip International Wholesalers, Corp. · NBW · Aug 11, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040848
• Device Name: EZ SMART
• Applicant: Vip International Wholesalers, Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 11, 2004
• 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 Blood Glucose 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 professional settings to monitor blood glucose levels. 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 whole blood samples using test strips and a meter. Principle of operation: glucose oxidase chemical reaction produces current measured by meter. Device displays glucose concentration directly without user calculation. Used in home and professional settings by patients or clinicians. Output provides blood glucose levels to assist in glucose control. Benefits include convenient, rapid monitoring of glucose levels.

Clinical Evidence

OTC clinical study with 203 patients; patients performed fingerstick tests unassisted. Compared EZ Smart results against Bayer Elite and YSI 2300 reference method. 91.1% of results were within 20% of YSI values. Precision studies (within-run and between-run) conducted across 5 glucose concentrations (30-400 mg/dL) showed CVs ranging from 1.17% to 5.35%.

Technological Characteristics

Glucose oxidase electrochemical biosensor. Measuring range: 20-600 mg/dL. Measurement time: 10 seconds. Dimensions: 94 x 49 x 17 mm. Standalone meter.

Indications for Use

Indicated for monitoring blood glucose levels in diabetics in home and professional settings. Not for neonates, diabetes 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 with the Elite Test Strips (K964630, K992342)

Submission Summary (Full Text)

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# AUG 11 2004

## 510(k) Summary

for

## EZ Smart Blood Glucose Monitoring System

## 1. DATE PREPARED

March 29, 2004

### 2. SPONSOR INFORMATION

Address

VIP International Wholesalers, Corp. 1860 Clove Road Staten Island, NY 10304

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

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

Outside Regulatory Counsel

Gray Cary Ware & Freidenrich LLP 1625 Massachusetts Ave., NW Suite 300 Washington, DC 20036

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

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

## 3. DEVICE NAME

EZ Smart Blood Glucose Monitoring Proprietary Name: System

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

## 4. DEVICE DESCRIPTION AND INTENDED USE

The EZ Smart Blood Glucose Test Strips are used with the EZ Smart Blood Glucose 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 professional settings to monitor blood glucose levels. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

## 5. PREDICATE DEVICE

- Predicate device name 1. Bayer Elite with the Elite Test Strips
- Predicate K Number 2. K964630 (Bayer Elite) K991242 (Bayer Elite Test Strips)

#### Substantial Equivalence Comparison 3.

| Item | Predicate Device<br>Bayer ELITE (K964630) | Proposed Device<br>EZ Smart |
|--------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Similarities | 1. Monitors glucose using<br>whole blood. | 1. Monitors glucose using<br>whole blood. |
| | 2. Directly displays results<br>without requiring<br>calculation. | 2. Directly displays results<br>without requiring<br>calculation. |
| | 3. Test principle includes<br>measuring a current<br>produced by a chemical<br>reaction. | 3. Test principle includes<br>measuring a current<br>produced by a chemical<br>reaction. |
| | 4. Test principle: Uses<br>glucose oxidase reaction. | 4. Test principle: Uses<br>glucose oxidase reaction. |
| | 5. Measuring range:<br>20 to 600mg/dL. | 5. Measuring range:<br>20 to 600mg/dL. |

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| Differences | ELITE | EZ Smart |
|-------------|---------------------------------------------------------------|-------------------------------------------------------------|
| | 1. Size: 97.8 x 56 x 14.5 mm<br>2. Measuring time: 30 seconds | 1. Size: 94 x 49 x 17 mm.<br>2. Measuring time: 10 seconds. |

#### 6. PERFORMANCE CHARACTERISTIC SUMMARY

An evaluation of the EZ Smart was conducted under various conditions including temperature effects, hematocrit levels, sensitivity and linearity, and presence of interferences. The results of the evaluation demonstrate that the EZ Smart is equivalent in performance to the predicate device and suitable for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned to the right of the text, which is arranged in a circular pattern around the bird. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Public Health Service

AUG 11 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

VIP International Wholesalers, Corp. c/o David Rosen 1625 Massachusetts Avenue NW Suite 300 Washington, DC 20036-2247

k040848 Re:

K040046
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: July 16, 2004 Received: July16, 2004

Dear Mr. Rosen:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premaince is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manatisa provice Amendments, or to commerce prof to May 26, 1776, the encordance with the provisions of the Federal Food, Drug, devices that have been icclassified in accoraanse what a proval application (PMA). and Cosmetic Act (Act) that to not require subject to the general controls provisions of the Act. The You may, mercrore, market the act include requirements for annual registration, listing of general controls provisions of the rice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (360 a00 v) into . Existing major regulations affecting your device il may be subject to such additional controllar contractions (CFR), Parts 800 to 895. In addition, FDA can be found in Thic 21, Code of I concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issualles or a cosence complies with other requirements of the Act that I DA has made a decorminations administered by other Federal agencies. You must of any I cuclar statutes and regarations and limited to: registration and listing (21 Compry with an the Free 5 require 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) I mis lotter will and w yourse FDA finding of substantial equivalence of your device to a legally promatication of 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, If you desire upomotion 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 I va inal 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,

Sean M. Cooper, US, DVM.

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

Enclosure

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# Indications for Use

K040848 510(k) Number:

Device Name: EZ Smart Blood Glucose Monitoring System

Indications For Use:

The EZ Smart Blood Glucose Test Strips are uses with the EZ Smart Meter to measure Glucose (sugar) in whole blood. The EZ Smart Test strips are for testing outside the Glasse (vegaliagnostic 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.

George P. Dungan R.Ph., M.S.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use ves (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)

Carol Benson
Division Sign-Off

Page 1 of

e of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040848