BIOSCANNER 2000

K013068 · Polymer Technology Systems, Inc. · CGA · Nov 20, 2001 · Clinical Chemistry

Device Facts

• Record ID: K013068
• Device Name: BIOSCANNER 2000
• Applicant: Polymer Technology Systems, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Nov 20, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The BioScanner Glucose Test Strips are intended to be used by healthcare professionals to measure glucose in whole blood and by individuals with diabetes to measure fingerstick whole blood at home. Glucose measurements are used in the management of carbohydrate metabolism disorders.

Device Story

BioScanner Glucose Test Strips measure glucose concentration in whole blood samples. The device utilizes a glucose oxidase reaction involving peroxidase, 4-aminoantipyrine, and a di-substituted aniline to generate a colored end product. The BioScanner instrument measures the percent reflectance of this color and converts the value into a glucose concentration. The system requires a lot-specific memory chip, packaged with the strips, for result calculation. Used by healthcare professionals in clinical settings and by patients for home monitoring; results assist in the management of carbohydrate metabolism disorders.

Clinical Evidence

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

Technological Characteristics

Reflectance photometry-based glucose test system. Reagents: glucose oxidase, peroxidase, 4-aminoantipyrine, and di-substituted aniline. Requires lot-specific memory chip for calibration. Quantitative measurement of glucose in whole blood.

Indications for Use

Indicated for healthcare professionals and individuals with diabetes for the management of carbohydrate metabolism disorders by measuring glucose in whole blood (including fingerstick samples).

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)

{0}------------------------------------------------

# SECTION E: 510(k) SUMMARY

K013068

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

November 9, 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 Glucose Test Strips

Classification Name: Glucose test system

Panel: Clinical Chemistry 75

Product Code: NBW

Device Classification: Class II

#### Intended Use

The BioScanner Glucose Test Strips are intended to be used by healthcare professionals to measure glucose in whole blood and by individuals with diabetes to measure fingerstick whole blood at home. Glucose measurements are used in the management of carbohydrate metabolism disorders.

#### Device Description

Glucose in the whole blood sample reacts with glucose oxidase in the presence of peroxidase, 4-aminoantipyrine and a di-substituted aniline to produce a colored end product. The BioScanner reads the percent reflectance of the color produced and converts reflectance into glucose concentration.

{1}------------------------------------------------

### Predicate Device Information

# STATEMENT OF SUBSTANTIAL EQUIVALENCE

Polymer Technology Systems, Inc. intends to introduce into commercial distribution the BioScanner Glucose Test Strips for the quantitative determination of Glucose in human whole blood. The BioScanner 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:

# Similarities and Differences (Predicate and BioScanner 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 reagents are similar in their composition in that both use a glucose oxidase reaction. .
- Both systems require a lot specific memory chip for result calculation. Both systems . contain the lot specific memory chip in the same package with the strips

#### Differences

- The Accu-Chek testing principle is based on an amperometric method in which a small . current produced in a chemical reaction is measured and converted to a glucose result.
- The BioScanner Glucose Test Strips use reflectance photometry to measure a color . change that is converted to a glucose result.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with outstretched wings. The bird is enclosed in a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 4 - 2005

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

Re: k013068

> Trade/Device Name: BioScanner Glucose Test Strips Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II, Class II Product Code: NBW, CGA Dated: March 23,2005 Received: March 28,2005

Dear Ms. Enright:

This letter corrects our substantially equivalent letter of August 28, 2001 regarding the indications for is for your device. These types of devices are cleared for management of carbohydrate metabolism disorder and not for diagnosis of such disorders.

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).

{3}------------------------------------------------

### 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,

Jean M. Cooper, M.S., 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

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known):_K013068

Device Name:_BioScanner Glucose Test Strips

Indications For Use:

The BioScanner Glucose Test Strips are intended to be used by healthcare professionals to measure The BioScanner Giucose Test Strips are micheer to be assure glucose in fingerstick whole blood at
glucose in whole blood and by individuals with diabetes to reacheliem disor glucose in whole brood and by interviduals with ensected of carbohydrate metabolism disorders.

Prescription Use X (Part 21 CFR 801 Subpart D)

Image /page/4/Picture/6 description: The image shows the text "AND/OR" with the word "AND" enclosed in a box. The slash between "AND" and "OR" indicates that either one or both of the conditions can be true. The text is written in a simple, sans-serif font.

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)

Carol C. Benem
ion Sign-Off

Page 1 of 1

frice of In Vitro Diagnostic Device cluation and Safety

K013068

4