SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM

K970556 · Lifescan, Inc. · CGA · May 12, 1997 · Clinical Chemistry

Device Facts

• Record ID: K970556
• Device Name: SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Lifescan, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: May 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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

Device Story

System comprises glucose reagent test strips, reflectance photometer, and quality control solutions; optional data management system for hospital tracking. Device measures glucose via reflectance photometry; provides quantitative blood glucose results. Used in clinical settings by healthcare professionals and in home settings by lay users. Output assists in glucose monitoring and clinical decision-making for diabetes management.

Technological Characteristics

Reflectance photometer; glucose reagent test strips; quality control solutions. System utilizes glucose oxidase chemistry. Includes data management system for hospital tracking.

Indications for Use

Indicated for quantitative blood glucose measurement in adults and neonates; suitable for arterial, venous, and capillary whole blood samples in clinical settings and capillary blood glucose monitoring for lay users in home environments.

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

• LifeScan SureStep® Blood Glucose Monitoring System
• LifeScan ONE TOUCH® II Hospital Blood Glucose Monitoring System

Submission Summary (Full Text)

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LifeScan Inc.
SureStep®Pro blood glucose monitoring system
510(k) Submission
K970556
MAY 12 1997

# 510(k) Summary
## Summary of Safety and Effectiveness

| Submitter | LifeScan, Inc.
1000 Gibraltar Drive
Milpitas, CA 95035
Judy Martin, RAC |
| --- | --- |
| Date | February 10, 1997 |
| Proprietary Name | LifeScan SureStep®Pro blood glucose monitoring system |
| Common name | Blood glucose monitor |
| Classification name | 75CGA: glucose oxidase, glucose test system |

## Device description

The SureStepPro blood glucose monitoring system consists of a glucose reagent test strip, a reflectance photometer, and quality control solutions. A data management system for hospital tracking of patient and quality control information will also be available.

## Intended Use

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

## Substantial Equivalence

The LifeScan SureStepPro blood glucose monitoring system is substantially equivalent to the currently marketed LifeScan SureStep® Blood Glucose Monitoring System and the LifeScan ONE TOUCH® II Hospital Blood Glucose Monitoring System.

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