ELECSYS CALCHECK CEA

K970459 · Boehringer Mannheim Corp. · JJX · Mar 6, 1997 · Clinical Chemistry

Device Facts

• Record ID: K970459
• Device Name: ELECSYS CALCHECK CEA
• Applicant: Boehringer Mannheim Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

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

Device Story

Elecsys CalCheck AFP; three-level, lyophilized, human serum-based material; used to verify calibration assignment for Elecsys AFP assay. Device reconstituted, assayed in triplicate, and results compared to target values. Used in clinical laboratory settings by laboratory personnel. Provides verification of assay calibration accuracy; ensures reliable patient test results.

Clinical Evidence

No clinical data. Bench testing only; performance characteristics regarding value assignment and stability provided in labeling.

Technological Characteristics

Lyophilized human serum-based material; three-level configuration (low, mid, high); single analyte (AFP).

Indications for Use

Indicated for use as a calibration verification material for the Boehringer Mannheim Elecsys AFP assay to verify calibration assignment.

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

• Elecsys® CalCheck™ CEA (K963147)
• Elecsys® CalCheck™ TSH (K963147)

Submission Summary (Full Text)

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MAR - 6 1997
K970459

# 510(k) 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
(510) 827 - 8215
Fax number: [phone]

Contact Person: Patricia Klimley
Date Prepared: January 29, 1997

## 2. Device Name

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

## 3. Predicate device

The Elecsys® CalCheck™ AFP is substantially equivalent to the currently marketed Elecsys® CalCheck™ CEA (K963147).

## 4. Device Description

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

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# 510(k) Summary, Continued

## 5. Intended use

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

## 6. Comparison to predicate device

The Elecsys® CalCheck™ AFP is substantially equivalent to the currently marketed Elecsys® CalCheck™ TSH (K963147).

The following table compares the Elecsys® CalCheck™ AFP with the predicate devices, Elecsys® CalCheck™ TSH. Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5. Labeling for the predicate devices is provided in attachment 6.

### Similarities:

- Configuration: 3 CalCheck levels: low, mid, and high
- Intended use: To verify calibration

### Differences:

| Feature | CalCheck AFP | CalCheck TSH |
| --- | --- | --- |
| Matrix type | Human serum | Horse serum |
| Analyte | AFP | TSH |

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# 510(k) Summary, Continued

6. Comparison to predicate device, (cont.)
Performance Characteristics:
- Value assignment and stability