BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM

K022581 · Becton, Dickinson & CO · NBW · Oct 9, 2002 · Clinical Chemistry

Device Facts

• Record ID: K022581
• Device Name: BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Becton, Dickinson & CO
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 9, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The BD Logic™ Blood Glucose Monitor is intended to be used for the quantitative measurement of glucose in whole blood. It is intended for use by people with diabetes mellitus in the home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The BD Logic™ Blood Glucose Monitor is specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the fingertip.

Device Story

BD Logic Blood Glucose Monitor is a home-use diagnostic device for patients with diabetes mellitus. It accepts capillary blood samples (0.3 µL) applied to a test strip. The device utilizes amperometric biosensor technology; reagents on the strip react with blood glucose to generate an electrical current; the meter measures this current to calculate glucose concentration. Results are displayed in 5 seconds. The system is designed as an integrated unit, housing the meter, test strips, lancing device, lancets, and insulin delivery supplies. Patients use the output to monitor diabetes control effectiveness. The device provides a convenient, all-in-one solution for daily diabetes management.

Clinical Evidence

Laboratory and clinical studies were conducted to demonstrate performance. Results indicate the device performs in an equivalent manner to the predicate device. No specific numerical metrics (e.g., sensitivity, specificity, or p-values) were provided in the summary document.

Technological Characteristics

Biosensor-based amperometric technology. Measures glucose concentration by detecting current generated by reagent-blood reaction on test strips. Integrated system form factor includes meter, test strip storage, and lancing/insulin delivery accessories. Standalone device.

Indications for Use

Indicated for quantitative blood glucose measurement in people with diabetes mellitus for home monitoring of diabetes control. Not for diagnosis, screening, or neonatal use. Samples obtained from fingertip.

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

• Glucometer DEX Test Sensor

Submission Summary (Full Text)

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1022581

# 510K Summary of Safety and Effectiveness

### 1. Submitted By:

OCT 0 9 2002

John Schalago Manager, Regulatory Affairs

Becton Dickinson Consumer Healthcare 1 Becton Drive Franklin Lakes, NJ 07417-1883

201-847-5663 Phone: Fax: [phone]

#### 2. Device Name:

| Trade Name: | BD LogicTM Blood Glucose Monitor |
|----------------------|--------------------------------------|
| Common Names: | Glucose oxidase, glucose test system |
| Classification Name: | Glucose oxidase, glucose test system |

#### 3. Predicate Device:

Glucometer DEX Test Sensor

Manufactured by: Bayer Diagnostics

#### 4. Device Description:

The BD Logic™ Blood Glucose Monitor is intended for use in the quantitative measurement of glucose in capillary blood collected from fingertips.

The BD Logic™ Blood Glucose Monitor is designed to be simple and easy to use. It provides accurate blood glucose test results in 5 seconds using a small (0.3 µL) sample volume. The system also offers the convenience of containing all of the daily needs for diabetes care in one place as the System includes the blood glucose meter and conveniently holds the test strip vial, lancing device, spare lancets, insulin pen and additional insulin pen needles.

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## Intended Use: 5.

The BD Logic™ Blood Glucose Monitor is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by people with diabetes mellitus in the home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

The BD Logic™ Blood Glucose Monitor is specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the fingertip.

### 6. Technological Characteristics:

The BD Logic™ Blood Glucose Monitor is based on biosensor technology. When blood is applied to the Blood Glucose Test Strip, reagents on the test strip react with the blood and a current is generated. The BD Logic™ Blood Glucose Monitor employs amperometric technology to measure the glucose concentrations in the blood sample by measuring the amount of current that is generated and flows through the electrodes on the test strip.

### 7. Performance Summary:

Laboratory and clinical studies demonstrate that the BD Logic™ Blood Glucose Monitor performed in an equivalent manner to the predicate and is suitable for its intended use.

The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E, under which a device can be marketed without pre-approval or classification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US patent Laws or their application by the courts.

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Image /page/2/Picture/0 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The symbol in the center consists of three stylized lines that resemble a person or abstract form.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

ood and Drug Administration 098 Gaither Road Rockville MD 20850

Mr. John A. Schalago MS, RAC Regulatory Affairs Manager Becton, Dickinson and Company l Becton Drive Franklin Lakes, NJ 07417

OCT 9 - 2002

Re: k022581

> Trade/Device Name: BD Logic™ Blood Glucose Monitor Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW; JJX, CGA Dated: August 2, 2002 Received: August 5, 2002

Dear Ms. Schalago:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsmaldsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known

Device Name: BD Logic™ Blood Glucose Monitor

Indications For Use:

The BD Logic™ Blood Glucose Monitor is intended to be used for the quantitative measurement of glucose in whole blood. It is intended for use by people with diabetes mellitus in the home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

The BD Logic™ Blood Glucose Monitor is specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the fingertip.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Sean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K022581

Over-the-counter

000021