SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM

K023832 · Lifescan, Inc. · NBW · Dec 13, 2002 · Clinical Chemistry

Device Facts

• Record ID: K023832
• Device Name: SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Lifescan, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 13, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SURESTEP Hospital Blood Glucose Monitoring System is for in vitro diagnostic use for the quantitative measurement of glucose in venous, capillary, arterial, and neonatal whole blood samples. Lay users can also use the system to test capillary blood.

Device Story

System consists of reflectance photometer, test strips, quality control/linearity solutions, and lancing accessories. User applies blood sample to test strip; glucose oxidase reaction produces hydrogen peroxide; peroxidase mediates indicator dye transformation to blue color. Meter measures light reflectance of blue product; converts reflectance to glucose concentration; displays result on LCD. User enters lot-specific calibration code. Used in hospital settings by clinicians and by lay users for capillary testing. Provides quantitative glucose values to assist in glycemic management.

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 use by healthcare professionals and lay users (capillary blood only).

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
• SURESTEP® Blood Glucose Monitoring System

Submission Summary (Full Text)

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# DEC 1 3 2002

## 510(k) Summary

| Submitter | LifeScan, Inc.<br>1000 Gibraltar Drive<br>Milpitas, CA 95035<br>Contact: John E. Hughes<br>Date Prepared: November 12, 2002 |
|------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Device Name | SURESTEP® Hospital Blood Glucose Monitoring System<br>Common name: Glucose test system |
| Predicate Device | SURESTEP®PRO Blood Glucose Monitoring System<br>SURESTEP® Blood Glucose Monitoring System |

#### Device Description

The SURESTEP Hospital Blood Glucose Monitoring System consists of a test 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 lancets) 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 test strips.

#### Intended Use

The SURESTEP Hospital Blood Glucose Monitoring System is for in vitro diagnostic use for the quantitative measurement of glucose in venous, capillary, arterial, and neonatal whole blood samples. Lay users can also use the system to test capillary blood.

#### Comparison to Predicate Device

The existing labeling for the SURESTEP Hospital Blood Glucose Monitoring System has been simplified to increase understanding and provide clear explanations of the performance capabilities and the performance limitations of the system.

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## Conclusion

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The modified SURESTEP Hospital Blood Glucose Monitoring System is substantially equivalent to the predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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DEC 1 3 2002

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

Re: k023832

Trade/Device Name: SureStep® Hospital Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: November 15, 2002 Received: November 18, 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 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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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). 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number:

K023832

Device Name:

SURESTEP® Hospital Blood Glucose Monitoring System

Indications for Use:

The SURESTEP Hospital Blood Glucose Monitoring System is for in vitro diagnostic use for the quantitative measurement of glucose in venous, capillary, arterial, and neonatal whole blood samples. Lay users can also use the system to test capillary blood.

Lan Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices

Division of Clinical Laboratory Devices 510(k) Number _ 1) 02

Concurrence of CDRH, Office of Device Evaluation

Prescription Use
(Per 21 CFR 801.109) ***_***_

OR

Over-the-Counter Use