ACCUREX GLUCOSE TEST STRIP

K052207 · Incline Medical, LLC · CGA · Mar 9, 2006 · Clinical Chemistry

Device Facts

• Record ID: K052207
• Device Name: ACCUREX GLUCOSE TEST STRIP
• Applicant: Incline Medical, LLC
• Product Code: CGA · Clinical Chemistry
• Decision Date: Mar 9, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Accurex Glucose Test Strips for use with the following glucometers: OneTouch Basic, OneTouch II and OneTouch Profile meters, all manufactured by Lifescan, Inc. It is to be used for the quantitative measurement of glucose in fresh capillary whole blood. Glucose measurements are used as an aid to monitor the effectiveness of diabetes control.

Device Story

Accurex Glucose Test Strip is a generic replacement strip for Lifescan OneTouch meters. Device uses membrane technology with glucose oxidase/peroxidase reaction to measure glucose in fresh capillary whole blood. User inserts strip into compatible meter, applies blood sample to test spot; meter displays quantitative glucose result. Used by patients for home diabetes monitoring. Device provides aid in assessing effectiveness of diabetes control. Performance validated against YSI 2300D clinical analyzer; results show high correlation with predicate device.

Clinical Evidence

No clinical data provided; device is a generic replacement for a legally marketed predicate.

Technological Characteristics

White plastic test strip containing glucose oxidase (Aspergillus niger), peroxidase (horseradish), color indicator, stabilizers, and buffers. Dimensions: 0.6" W x 1.75" L. Sensing principle: enzymatic colorimetric reaction. Requires external meter (OneTouch Basic, II, or Profile) for signal processing and display. Sterilization not specified.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood to monitor diabetes control in patients requiring glucose testing.

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

• One Touch Glucose Test Strip (k923544)

Submission Summary (Full Text)

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2006 MAR 9

K052207

# Incline Medical, LLC

13560 SW Willow Top Lane Tigard, OR 97224 408-850-0198

### SUMMARY

Submitter's name: Address:

Incline Medical, LLC 13560 SW Willow Top Lane Tigard, OR 97224 408-850-0198

Phone:

Name of contact person:

Greg Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: [phone] Fax: [phone]

Date the summary was prepared: August 8, 2005

| Trade Name: | Accurex Glucose Test Strip |
|----------------------|----------------------------|
| Common/Usual Name: | Glucose Test System |
| Classification Name: | Glucose Oxidase, Glucose |

The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]:

One Touch Glucose Test Strip, K923544 manufactured by Lifescan Inc.

Description of the device:

The Accurex Glucose Test Strip is a generic replacement for the Lifescan One Touch Glucose Test Strip. These glucose test strips can be used with the following glucometers:

One Touch Profile One Touch II One Touch Basic (with large screen) One Touch Basic (with small screen)

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Indications:

The Accurex Glucose Test Strip for use with the following glucometers: One Touch, One Touch II and One Touch Basic, all manufactured by Lifescan, Inc.

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 tumors.

Summary of the technological characteristics of our device compared to the predicate device:

The Accurex Glucose Test Strip were compared to the predicate in the following areas and found to have similar technological characteristics and to be equivalent.

Indications for use Target population Where used Method Comparison Technical Comparison

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine and health, with a circle of text surrounding it. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)". The logo is black and white.

### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

#### MAR 9 2006

Incline Medical, LLC. c/o Mr. Greg Holland Regulatory Specialist Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine. CA 92606

k052207 Re:

Trade/Device Name: Accurex Glucose Test Strips Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA, NBW Dated: February 27, 2006 Received: February 28, 2006

Dear Mr. Holland:

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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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,

Alberto Gutz

Alberto Gutierrez, Ph.D. 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 (if known): K052207

Device Name: Accurex Glucose Test Strips

Indications For Use:

The Accurex Glucose Test Strip for use with the following glucometers: One Touchi Basic, OneTouch II and OneTouch Profile meters, all manufactured by Lifescan, Inc.

It is to be used for the quantitative measurement of glucose in fresh capillary whole blood. Glucose measurements are used as an aid to monitor the effectiveness of diabetes control.

Prescription Use _ OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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Office of in Vitro Diagnostic Device Evaluation and Safety

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