SURESTEP BLOOD GLUCOSE MONITORING SYSTEM

K984261 · Lifescan, Inc. · CGA · May 21, 1999 · Clinical Chemistry

Device Facts

• Record ID: K984261
• Device Name: SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Lifescan, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: May 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SURESTEP Blood Glucose Monitoring System is intended for quantitative measurement of glucose in a sample of whole blood. It can be used by lay persons for capillary blood glucose monitoring in the home. It can also be used by healthcare professionals in a clinical setting to measure glucose in arterial, venous and capillary samples in both adults and neonates.

Device Story

System comprises glucose reagent test strips, reflectance photometer, and quality control materials; may include data management hardware/software. Device measures glucose concentration in whole blood samples. Reflectance photometry principle used to quantify glucose via reagent reaction. Used in home settings by patients or clinical settings by healthcare professionals. Output provides quantitative glucose levels to assist in diabetes management and clinical decision-making. Benefits include rapid, accessible glucose monitoring for both professional and personal use.

Clinical Evidence

No clinical data provided in the summary document; device relies on substantial equivalence to previously cleared predicate devices.

Technological Characteristics

Reflectance photometer; glucose oxidase reagent test strips; supports capillary, venous, and arterial whole blood samples. Includes optional data transfer/management hardware and software.

Indications for Use

Indicated for quantitative blood glucose measurement in adults and neonates. Suitable for home use (capillary blood) by lay persons and clinical use (arterial, venous, capillary blood) by healthcare professionals.

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 Blood Glucose Monitoring System (K942455)
• SURESTEPPRO Blood Glucose Monitoring System (K970556)

Submission Summary (Full Text)

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

MAY 2 1

| Submitter | LifeScan, Inc.<br>1000 Gibraltar Drive<br>Milpitas, CA 95037 |
|------------------|--------------------------------------------------------------|
| Contact | James Phelps/Roger Thies<br>Hyman, Phelps, and McNamara |
| Date | 11/25/98 |
| Proprietary Name | LifeScan SURESTEP® Blood Glucose<br>Monitoring System |
| Common Name | Blood Glucose Monitor |
| Classification | 75CGA: glucose oxidase, glucose<br>test system |

# 510(k) Summary Summary of Safety and Effectiveness

#### Device Description

The SURESTEP Blood Glucose Monitoring System consists of a glucose reagent test strip, a reflectance photometer and quality control materials and may include data transfer or management hardware and/or software tools.

#### Intended Use

The SURESTEP Blood Glucose Monitoring System is intended for quantitative measurement of glucose in a sample of whole blood. It can be used by lay persons for capillary blood glucose monitoring in the home. It can also be used by healthcare professionals in a clinical setting to measure glucose in arterial, venous and capillary samples in both adults and neonates.

#### Substantial Equivalence

The LifeScan SURESTEP Blood Glucose Monitoring System is substantially equivalent to the original SURESTEP Blood Glucose Monitoring System, K942455, and the SURESTEPPRO Blood Glucose Monitoring System, k970556.

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

Public Health Service

Image /page/1/Picture/2 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 with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle image.

MAY 2 1 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

LifeScan c/o James R. Phelps Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street. N.W. Suite 1200 Washington, D.C. 20005

Re: K984261

> Trade Name: LifeScan SureStep® Blood Glucose Monitoring System Regulatory Class: II Product Code: CGA Dated: May 14, 1999 Received: May 17, 1999

Dear Mr. Phelps:

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 (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). 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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.

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

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/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

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

LifeScan, Inc. SureStep Blood Glucose Monitoring System 510(k) Submission

## Statement of Intended Use

Device Name:

LifeScan SureStep® Blood Glucose Monitoring System

### Indications for Use:

The LifeScan SureStep Blood Glucose Monitoring System is intended for quantitative measurement of glucose in a sample of whole blood. It can be used by lay persons for capillary blood glucose monitoring in the home. It can also be used in a clinical setting to measure glucose in arterial, venous, and capillary samples in both adults and neonates.

Sean Coogan

(Division Sign-Off) Division of Clinical Laboratory Devices a 2-510(k) Number

OR

Prescription Use (Per 21 CFR 801.109) Over-The Counter Use _ ▽

(Optional Format 1-2-96)