ELECSYS CALCHECK PROLACTIN

K970147 · Boehringer Mannheim Corp. · JJY · Feb 10, 1997 · Clinical Chemistry

Device Facts

• Record ID: K970147
• Device Name: ELECSYS CALCHECK PROLACTIN
• Applicant: Boehringer Mannheim Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Feb 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Boehringer Mannheim Elecsys® CalCheck™ Prolactin is used to verify the calibration assignment for the Boehringer Mannheim Elecsys Prolactin assay.

Device Story

Elecsys CalCheck Prolactin; calibration verification material for Elecsys Prolactin assay. Manufactured using human serum albumin and human Prolactin; analyte spiked into matrix at specific concentration levels. Used in clinical laboratory settings on automated immunoassay analyzers. Provides verification of calibration assignment; ensures accuracy of assay results. Benefits patient by maintaining analytical performance and reliability of Prolactin testing.

Clinical Evidence

Bench testing only. Evaluation performed for value assignment and stability.

Technological Characteristics

Calibration verification material; human serum albumin and human Prolactin matrix. Liquid form. Used with automated immunoassay analyzers.

Indications for Use

Indicated for use in verifying calibration assignments for the Boehringer Mannheim Elecsys Prolactin assay on automated immunoassay analyzers.

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)

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K970147 FEB 10 1997

# BOEHRINGER MANNHEIM CORPORATION

## 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 Prolactin

Common name: Calibration Verification Material

Classification name: Single (specified) analyte controls (assayed + unassayed) |
| 3. Predicate device | The Boehringer Mannheim Elecsys CalCheck Prolactin is substantially equivalent to the currently marketed Tosoh Medics AIA-Pack FSH Calibration Verification Test. (K924863) |
| 4. Device Description | The Boehringer Mannheim Elecsys CalCheck Prolactin is manufactured using human serum albumin and human Prolactin. The analyte is appropriately spiked into the calcheck matrix to the correct calcheck concentration levels. The calcheck are in process checked and quality controlled. |

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BOEHRINGER MANNHEIM CORPORATION) Summary, Continued

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

6. Comparison to predicate device
The Boehringer Mannheim Elecsys® CalCheck™ Prolactin is substantially euivalent 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™ Prolactin was evaluated for value assignment and stability.

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