ELECSYS CALCHECK CEA

K970452 · Boehringer Mannheim Corp. · JJX · Mar 6, 1997 · Clinical Chemistry

Device Facts

• Record ID: K970452
• 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 Elecsys® CalCheck™ CEA is used to verify the calibration assignment for the Elecsys® CEA assay.

Device Story

Elecsys® CalCheck™ CEA consists of three levels of lyophilized, human-based materials; used to verify calibration assignment for Elecsys® CEA assay. Device used in clinical laboratory settings by laboratory personnel. After reconstitution, materials are assayed in triplicate; results compared to target values to confirm assay calibration accuracy. Benefits include ensuring reliable CEA test results for patient monitoring.

Clinical Evidence

Bench testing only. Performance characteristics, including value assignment and stability, were evaluated and incorporated into draft labeling.

Technological Characteristics

Three-level lyophilized human serum-based material. Analyte: CEA. Form factor: Reconstitutable powder. No software or electronic components.

Indications for Use

Indicated for use as a calibration verification material for the Elecsys® CEA 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™ TSH (K963147)

Submission Summary (Full Text)

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K970452
MAR - 6 1997

# 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 M. Klimley

Date Prepared: January 29, 1997 |
| 2. Device Name | Proprietary name: Elecsys CalCheck CEA

Common name: Calibration Verification Material

Classification name: Single (specified) analyte controls (assayed + unassayed) |
| 3. Predicate device | The Elecsys® CalCheck™ CEA is substantially equivalent to the currently marketed Elecsys® CalCheck™ TSH (K963147). |
| 4. Device Description | The Elecsys® CalCheck™ CEA 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 Elecsys® CalCheck™ CEA is used to verify the calibration assignment for the Elecsys® CEA assay.

6. Comparison to predicate device
The Elecsys® CalCheck™ CEA is substantially equivalent to the currently marketed Elecsys® CalCheck™ TSH (K963147).

The following table compares the Boehringer Mannheim Elecsys® CalCheck™ CEA with the predicate device, 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 CEA | CalCheck TSH |
| --- | --- | --- |
| Matrix type | Human serum | Horse serum |
| Analyte | CEA | TSH |

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# 510(k) Summary, Continued

6. Comparison to predicate device, (cont.)

Performance Characteristics:
- Value assignment and stability