ELECSYS CALCHECK TESTOSTERONE

K970146 · Boehringer Mannheim Corp. · JJX · Jan 30, 1997 · Clinical Chemistry

Device Facts

• Record ID: K970146
• Device Name: ELECSYS CALCHECK TESTOSTERONE
• Applicant: Boehringer Mannheim Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jan 30, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Boehringer Mannheim Elecsys CalCheck Testosterone is used to verify the calibration assignment for the Boehringer Mannheim Elecsys Testosterone assay.

Device Story

Calibration verification material; human serum albumin matrix spiked with testosterone, stabilizers, and preservatives. Used in clinical laboratories to verify calibration of Elecsys Testosterone assay on automated immunoassay analyzers. Quality controlled against ID-GC/MS. Provides healthcare providers with verification that assay calibration remains accurate, ensuring reliable patient testosterone measurement results.

Clinical Evidence

Bench testing only. Evaluation performed for value assignment and stability. Quality control verified against ID-GC/MS.

Technological Characteristics

Matrix: human serum albumin, testosterone, stabilizers, preservatives. Analyte concentration levels verified against ID-GC/MS. Form factor: liquid calibration verification material.

Indications for Use

Indicated for verification of calibration assignment for the Boehringer Mannheim Elecsys Testosterone assay in clinical laboratory settings.

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 Medics AIA-Pack FSH Calibration Verification Test (K924863)

Submission Summary (Full Text)

{0}

JAN 30 1997

K970146

BOEHRINGER
MANNHEIM
CORPORATION

# 1000 Summary

## 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
2400 Bisso Lane
Concord, CA 94524-4117
[phone] extension 8413
Fax number: [phone], x8413

Contact Person: Yvette Lloyd
Date Prepared: January 13, 1997

## 2. Device Name

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

## 3. Predicate device

The Boehringer Mannheim Elecsys CalCheck Testosterone is substantially equivalent to the currently marketed Tosoh Medics AIA-Pack FSH Calibration Verification Test. (K924863)

## 4. Device Description

The Boehringer Mannheim Elecsys CalCheck Testosterone is manufactured using human serum albumin, testosterone, stabilizers, and preservatives. The analyte is appropriately spiked into the calcheck matrix to the correct calcheck concentration levels. The calchecks are in process checked and quality controlled against ID-GC/MS.

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# BOEHRINGER MANNHEIM CORPORATION

## Summary, Continued

| 5. Intended use | The Boehringer Mannheim Elecsys CalCheck Testosterone is used to verify the calibration assignment for the Boehringer Mannheim Elecsys Testosterone assay. |
| --- | --- |
| 6. Comparison to predicate device | The Boehringer Mannheim Elecsys® CalCheck™ Testosterone 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 FSH Calibration Verification Test. (K924863)

Both products are intended to be used for the verification of calibration for analytes on automated immunoassay analyzers. |
| 7. Performance Characteristics | The Elecsys® CalCheck™ Testosterone was evaluated for value assignment and stability. |