ELECSYS CALCHECK HCG

K963165 · Boehringer Mannheim Corp. · JJX · Aug 30, 1996 · Clinical Chemistry

Device Facts

• Record ID: K963165
• Device Name: ELECSYS CALCHECK HCG
• Applicant: Boehringer Mannheim Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 30, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Elecsys CalCheck HCG is intended for use in the quantitative verification of the calibration curve established by the Elecsys HCG reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.

Device Story

Elecsys CalCheck HCG consists of three-level lyophilized, human-based materials; used to verify calibration curves of Elecsys HCG reagents on Elecsys 1010 or 2010 immunoassay analyzers. User reconstitutes material, assays in triplicate, and compares results to target values. Provides quality control for automated immunoassay systems; ensures accuracy of quantitative HCG measurements; supports clinical decision-making by validating analyzer performance.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Three-level lyophilized, human-based material. Designed for use with Elecsys 1010/2010 immunoassay analyzers. No specific materials of construction or software algorithms described.

Indications for Use

Indicated for use as a calibration verification material for the Elecsys HCG assay on Elecsys 1010 or 2010 immunoassay analyzers to verify the established calibration curve.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Tosoh Medic AIA-Pack HCG Calibration Verification Test Set (K924862)

Submission Summary (Full Text)

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K963165

AUG 30 1996

# 510(k) Summary

## Elecsys® CalCheck™ HCG

### Introduction

According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

### 1) Submitter name, address, contact

Boehringer Mannheim Corporation
9115 Hague Rd.
Indianapolis, IN 46250
[phone]

Contact Person: John D. Stevens
Date Prepared: August 12, 1996

### 2) Device name

Proprietary name: Elecsys CalCheck HCG
Common name: Calibration Verification Material
Classification name: Single (specified) analyte controls (assayed + unassayed)

### 3) Predicate device

We claim substantial equivalence to the Tosoh Medic AIA-Pack HCG Calibration Verification Test Set, K924862. The intended use for both products is to verify the calibration curve of automated immunoassay analyzers

### 4) Device Description

The Elecsys CalCheck HCG is a three level single analyte set of lyophilized, human based materials. After reconstitution they are assayed in triplicate and the results are compared to the target values.

### 5) Intended use

Elecsys CalCheck HCG is intended for use in the quantitative verification of the calibration curve established by the Elecsys HCG reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.

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# 510(k) Summary, Elecsys® CalCheck™ HCG, Continued

## 6) Comparison to predicate device

The Boehringer Mannheim Elecsys CalCheck HCG is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Tosoh Medics AIA-Pack HCG Calibration Verification Test Set, K924862.

The intended use of both the Elecsys CalCheck HCG and the predicate device are the same in that they are intended to be used for the calibration verification for their labeled analytes on automated immunoassay analyzers.