ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST

K944458 · Boehringer Mannheim Corp. · CHH · Mar 6, 1996 · Clinical Chemistry

Device Facts

• Record ID: K944458
• Device Name: ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST
• Applicant: Boehringer Mannheim Corp.
• Product Code: CHH · Clinical Chemistry
• Decision Date: Mar 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1175
• Device Class: Class 1

Intended Use

The Accutrend® Cholesterol Test is intended for the quantitative determination of total cholesterol in whole blood. The Accutrend® Cholesterol Test is intended for use by healthcare professionals and for home use.

Device Story

In vitro diagnostic test; measures total cholesterol in capillary whole blood; utilizes dry chemistry test strip; non-wipe technology; cholesterol esterase reaction; lot-specific coding; used for cholesterol screening; home or clinical setting; provides quantitative cholesterol levels; aids in lipid profile monitoring; supports patient self-management or physician-directed screening.

Technological Characteristics

Dry chemistry test strip; cholesterol esterase reaction; non-wipe technology; lot-specific coding.

Indications for Use

Indicated for quantitative determination of total cholesterol in whole blood for individuals performing cholesterol screening in clinical or home settings.

Regulatory Classification

Identification

A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Predicate Devices

• Chemtrak's AccuMeter Cholesterol Self Test

Submission Summary (Full Text)

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494458

# SUMMARY OF SAFETY AND EFFECTIVENESS

## ACCUTREND® CHOLESTEROL TEST
MAR - 6 1996

The Accutrend® Cholesterol Test is substantially equivalent to Chemtrak's AccuMeter Cholesterol Self Test. Both systems are used to measure total cholesterol in whole blood. The procedure for both tests entails applying a capillary blood sample to a dry chemistry test strip or cartridge. Both test systems utilize non-wipe technologies. The cholesterol esterase reaction is measured in both tests. Both test systems have lot-specific coding for each lot of test strips or cartridges. Finally, both the Accutrend and AccuMeter systems are cholesterol screening devices which have been cleared specially for home use.

Boehringer Mannheim Corporation
9115 Hague Road
Indianapolis, Indiana 46256