SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM

K023194 · Lifescan, Inc. · CGA · Oct 24, 2002 · Clinical Chemistry

Device Facts

• Record ID: K023194
• Device Name: SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM
• Applicant: Lifescan, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Oct 24, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SURESTEP®PRO and the SURESTEPFLEXX Professional Blood Glucose Management Systems are for in vitro diagnostic use for the quantitative measurement of glucose in venous, capillary, arterial, and neonatal whole blood samples. These systems can also be used by lay users at home.

Device Story

System consists of test strips, reflectance photometer, quality control/linearity solutions, and lancing devices. Input: blood sample (venous, capillary, arterial, neonatal) applied to test strip. Principle: glucose oxidase reaction produces hydrogen peroxide; peroxidase mediates indicator dye transformation to blue color. Meter measures reflected light intensity; converts reflectance data to glucose concentration via lot-specific calibration code. Output: glucose concentration displayed on LCD. Used in clinical settings and home environments by professionals or lay users. Facilitates blood glucose management; aids clinical decision-making through quantitative results.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and labeling modifications.

Technological Characteristics

Reflectance photometer; glucose oxidase/peroxidase enzymatic reaction; liquid crystal display; lot-specific calibration code entry; in vitro diagnostic system.

Indications for Use

Indicated for quantitative glucose measurement in venous, capillary, arterial, and neonatal whole blood samples. Suitable for professional clinical use and lay user home use.

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

• SURESTEP®PRO Blood Glucose Monitoring System

Submission Summary (Full Text)

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OCT 2 4 2002

K023194

# 510(k) Summary

| Submitter | LifeScan, Inc.<br>1000 Gibraltar Drive<br>Milpitas, CA 95035<br>Contact: John E. Hughes<br>Date Prepared: October 23, 2002 |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | SURESTEP®PRO Professional Blood Glucose Management System<br>SURESTEP®FLEXX Professional Blood Glucose Management<br>System<br>Common name: Glucose test system |
| Predicate Device | SURESTEP®PRO Blood Glucose Monitoring System |

#### Device Description

The SURESTEPPRO and SURESTEPFLEXX Systems consist of a rest strip (SURESTEPPRO Test Strips), a reflectance photometer, quality control solutions, and linearity solutions. Ancillary devices to aid in obtaining blood samples (e.g. lancing devices) and external data management computer software designed to facilitate storage and retrieval of results are also provided.

A sample is placed on a test strip and inserted into the reflectance photometer. Glucose in the sample reacts with oxygen in a glucose oxidase catalyzed reaction yielding gluconic acid and hydrogen peroxide. A second enzyme, peroxidase, mediates transformation of indicator dyes into products with a blue color. The intensity of the resulting blue color is proportional to the concentration of glucose in the sample. The meter measures the amount of light reflected by this blue colored product and converts the reflectance data into a glucose concentration that is displayed on a liquid crystal display. The user adjusts the meter response for each lot of test strips by entering a calibration code specific to that lot of rest strips.

### Intended Use

The SURESTEP®PRO and the SURESTEPFLEXX Professional Blood Glucose Management Systems are for in vitro diagnostic use for the quantitanive measurement of glucose in venous, capillary, arterial, and neonatal whole blood samples. These systems can also be used by lay users at home.

#### Comparison to Predicate Device

The existing labeling for the SURESTEPPRO Professional Blood Glucose Management System and the SURESTEPFLEXX Protessional Blood Glucose Management System has

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been simplified to increase understanding and provide clear explanations of the performance capabilities and the performance limitations of the system.

## Conclusion

The modified SURESTEPRO Professional Blood Glucose Management System and the SURESTEPFLEXX Professional Blood Glucose Management System is substantially equivalent to the predicate device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

Mr. John E. Hughes Manager, Regulatory Submissions LifeScan, Inc. 1000 Gibraltar Drive Milpitas, CA 95035-6312

Re: k023194

> Trade/Device Name: SureStep®Pro Professional Blood Glucose Management System SureStep®Flexx Professional Blood Glucose Management System

Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW; CGA Dated: September 24, 2002 Received: September 25, 2002

Dear Mr. Hughes:

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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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 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 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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# Indications for Use Statement

510(k) Number:

Device Name:

SURESTEP®PRO Professional Blood Glucose Management System SURESTEP®FLEXX Professional Blood Glucose Management System

Indications for Use:

The SURESTEP®PRO and the SURESTEPFLEXX Professional Blood Glucose Management Systems are for in virro diagnostic use for the quantitative measurement of glucose in venous, capillary, arterial, and neonatal whole blood samples. These systems can also be used by lay users at home.

ean
Cooper
(Division Sign-Off)
Division of Clinical Laborator
510(k) Number. K023194

Concurrence of CDRH, Office of Device Evaluation

Over-the-Counter Use***_***_

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Prescription Use (Par 21 CFR 801.109) OR