BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS

K013203 · Polymer Technology Systems, Inc. · NBW · Nov 16, 2001 · Clinical Chemistry

Device Facts

• Record ID: K013203
• Device Name: BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS
• Applicant: Polymer Technology Systems, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Nov 16, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The BioScanner Beyond Glucose test system is intended to be used to measure glucose by healthcare professionals in whole blood and by individuals with diabetes at home in fingerstick whole blood. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia and pancreatic islet cell tumors.

Device Story

BioScanner Beyond Glucose Test System measures glucose in whole blood samples. Input: fingerstick whole blood applied to test strips. Principle: glucose oxidase and ferricyanide reaction generates electrons; device measures resulting electrical current across two electrodes (amperometric method). Output: glucose concentration in mg/dL displayed on screen. Used by healthcare professionals in clinical settings and patients at home. Includes lot-specific memory chip for calibration. Benefits: provides quantitative glucose results for management of carbohydrate metabolism disorders; requires smaller blood sample volume than predicate.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and comparison of analytical performance to predicate device.

Technological Characteristics

Amperometric glucose oxidase biosensor. System includes test strips and lot-specific memory chip. Measures electrical current proportional to glucose concentration. Reported in mg/dL. Standalone device.

Indications for Use

Indicated for healthcare professionals and individuals with diabetes for quantitative glucose measurement in whole blood (fingerstick) to aid in diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, idiopathic hypoglycemia, and pancreatic islet cell tumors.

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

• Accu-Chek Comfort Curve Test Strips (K982002)

Submission Summary (Full Text)

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# NOV 1 62001

K013203

This summary of safety and effectiveness information is submitted in compliance with 21CFR807.92.

July 13, 2001

Submitter Information: Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, IN 46268

Contact Person: Margo Enright Phone Number: 317-870-5610 317-870-5608 FAX Number:

Trade Name: BioScanner Beyond Glucose Test Strips

Common Name: Glucose test system

Panel: Clinical Chemistry 75

Product Code: NBW

Device Classification: Class II

### Intended Use

The BioScanner Beyond Glucose test system is intended to be used to measure glucose by healthcare professionals in whole blood and by individuals with diabetes at home in fingerstick whole blood. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia and pancreatic islet cell tumors.

#### Device Description

Glucose in the whole blood sample reacts with glucose oxidase and ferricyanide. The reaction liberates electrons, which produce a small electrical current. The BioScanner Beyond reads the current produced across two electrodes and converts current into glucose concentration.

#### Predicate Device Information

## STATEMENT OF SUBSTANTIAL EQUIVALENCE

Polymer Technology Systems, Inc., intends to introduce into commercial distribution the BioScanner Beyond Glucose Test Strips for the quantitative determination of Glucose in human whole blood. The BioScanner Beyond Glucose Test Strips are substantially equivalent to the predicate device noted below.

Accu-Chek Comfort Curve Test Strips Name: Roche Diagnostics Device Company: K 982002 510(k) Number:

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## Similarities and Differences (Predicate and BioScanner Beyond Glucose)

### Similarities

- Both systems measure Glucose concentrations in blood. .
- Both systems provide a result that correlates to the laboratory plasma glucose . result.
- Both systems are calibrated with a glucose hexokinase laboratory method as the . reference.
- Both use the same testing principle (amperometric method) in which a small . current produced in a chemical reaction is measured and converted into a glucose result in concentration.
- Both reagents are similar in their composition in that both use a glucose oxidase . reaction. The current is measured and converted into glucose concentration and reported in mg/dL
- The predicate method requires an Accu-Chek code chip to access the lot code ● information ..

The BioScanner Beyond Glucose Test Strips contain a lot specific memory chip in the same package with the strips.

## Differences

- The BioScanner Beyond Glucose Analyzer requires about one-half of blood ● sample volume that the Accu-Chek Advantage requires
- The BioScanner Beyond Glucose Analyzer has a display screen that is about 7% ◆ larger than the Accu-Chek Advantage

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Margo Enright Manager of Clinical Affairs Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, IN 46268

NOV 1 62001

Re: K013203

Trade/Device Name: Bioscanner Beyond Glucose Test System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: II Product Code: NBW, CGA Dated: September 24, 2001 Received: September 25, 2001

Dear Mr. Enright:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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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## NOV 1 62001

Page

NUMBER (IF KNOWN) : 510 (k)

K013203

DEVICE NAME: BioScanner Beyond Glucose Test System

INDICATIONS FOR USE:

The BioScanner Beyond Glucose test system is intended to measure glucose by healthcare professionals in whole blood and by individuals with diabetes at home in fingerstick whole blood. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia and pancreatic islet cell tumors.

Han Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K013203

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use
(Optional Format 1-2-96)