ELECSYS CALCHECK LH

K964830 · Boehringer Mannheim Corp. · JJX · Dec 16, 1996 · Clinical Chemistry

Device Facts

• Record ID: K964830
• Device Name: ELECSYS CALCHECK LH
• Applicant: Boehringer Mannheim Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Dec 16, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

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

Device Story

Elecsys CalCheck LH serves as calibration verification material for Elecsys LH assay; manufactured using human serum albumin, luteinizing hormone, stabilizers, and preservatives. Analyte spiked into matrix to specific concentration levels. Quality controlled against Enzymun LH assay kit calibrators, value-assigned via comparison to 2nd International Standard (NIBSC) 80/552. Used by laboratory personnel to confirm assay calibration accuracy; ensures reliable patient test results.

Clinical Evidence

Bench testing only; evaluation focused on value assignment and stability of the CalCheck material.

Technological Characteristics

Calibration verification material; composition includes human serum albumin, luteinizing hormone, stabilizers, and preservatives. Value assignment traceable to NIBSC 80/552 standard.

Indications for Use

Indicated for use in verifying calibration assignment for the Boehringer Mannheim Elecsys LH 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 Medic AIA Pack for FSH (K924863)

Submission Summary (Full Text)

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K964830

# 510(k) Summary

DEC 16 1996

## 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]

Contact Person: Yvette Lloyd

Date Prepared: December 12, 1996

## 2. Device Name

Proprietary name: Elecsys CalCheck LH

Common name: Calibration Verification Material

Classification name: Single (specified) analyte controls (assayed + unassayed)

## 3. Predicate device

The Boehringer Mannheim Elecsys CalCheck LH is substantially equivalent to the Tosoh Medic AIA Pack for FSH. (K924863)

## 4. Device Description

The Boehringer Mannheim Elecsys CalCheck LH are manufactured using human serum albumin, luteinizing hormone, stabilizers and preservatives. The analyte is appropriately spiked into the calcheck matrix to the correct calcheck concentration levels. The calcheck are in process checked and quality controlled against the Enzymun® LH assay kit calibrators (prepared using a similar procedure), which have been value assigned by comparison to a 2nd International Standard (NIBSC) 80/552.

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# 510(k) Summary, Continued

5. Intended use
The Boehringer Mannheim Elecsys CalCheck LH is used to verify the calibration assignment for the Boehringer Mannheim Elecsys LH assay.

6. Comparison to predicate device.
**Performance Characteristics:**
- The Elecsys® CalCheck™ LH were evaluated for value assignment and stability.