THE ELECSYS CALCHECK PROGESTERONE

K970984 · Boehringer Mannheim Corp. · JJX · Apr 2, 1997 · Clinical Chemistry

Device Facts

• Record ID: K970984
• Device Name: THE ELECSYS CALCHECK PROGESTERONE
• Applicant: Boehringer Mannheim Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Apr 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

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

Device Story

Calibration verification material; human serum albumin matrix spiked with progesterone; stabilizers; preservatives. Used to verify calibration assignment for Elecsys Progesterone assay on automated immunoassay analyzers. Quality controlled against Enzymun Progesterone assay kit calibrators; value assigned via ID-GC/MS comparison. Assists clinicians in ensuring assay accuracy and reliability.

Clinical Evidence

Bench testing only. Evaluation focused on value assignment and stability of the calibration verification material.

Technological Characteristics

Human serum albumin matrix; progesterone analyte; stabilizers; preservatives. Liquid form. Value assignment via ID-GC/MS comparison.

Indications for Use

Indicated for verification of calibration assignment for the Boehringer Mannheim Elecsys Progesterone 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)

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APR -2 1997
K970984

# B0EHRINGER 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]

Contact Person: Yvette Lloyd

Date Prepared: March 13, 1997 |
| 2. Device Name | Proprietary name: Elecsys CalCheck Progesterone

Common name: Calibration Verification Material

Classification name: Single (specified) analyte controls (assayed + unassayed) |
| 3. Predicate device | The Boehringer Mannheim Elecsys CalCheck Progesterone is substantially equivalent to the currently marketed Tosoh Medics AIA-Pack FSH Calibration Verification Test. (K924863) |
| 4. Device Description | The Boehringer Mannheim Elecsys CalCheck Progesterone is manufactured using human serum albumin, progesterone, stabilizers, and preservatives. The analyte is appropriately spiked into the calibrator matrix to the correct calibrator concentration levels. The calibrators are in process checked and quality controlled against the Enzymun® Progesterone assay kit calibrators (prepared using a similar procedure) which have been value assigned by comparison to ID-GC/MS. |

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BOEHRINGER MANNHEIM CORPORATION
Summary, Continued

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

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

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