← Product Code [CHH](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHH) · K944458

# ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST (K944458)

_Boehringer Mannheim Corp. · CHH · Mar 6, 1996 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHH/K944458

## Device Facts

- **Applicant:** Boehringer Mannheim Corp.
- **Product Code:** [CHH](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHH.md)
- **Decision Date:** Mar 6, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1175
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Indications for 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.

## Regulatory 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)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

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

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHH/K944458](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHH/K944458)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com