ELECSYS CALCHECK FSH

K964829 · Boehringer Mannheim Corp. · JIX · Dec 16, 1996 · Clinical Chemistry

Device Facts

• Record ID: K964829
• Device Name: ELECSYS CALCHECK FSH
• Applicant: Boehringer Mannheim Corp.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Dec 16, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

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

Device Story

Calibration verification material; used to verify calibration assignment for Elecsys FSH assay. Manufactured using human serum albumin, follicle stimulating hormone, and stabilizers. Analyte spiked into matrix to specific concentration levels. Quality controlled against Enzymun FSH assay kit calibrators. Used in clinical laboratory settings by laboratory personnel. Provides verification of assay calibration accuracy.

Clinical Evidence

Bench testing only. Evaluated for value assignment and stability.

Technological Characteristics

Matrix: human serum albumin, follicle stimulating hormone, stabilizers. Analyte spiked to specific concentration levels. Quality control performed against Enzymun FSH assay kit calibrators.

Indications for Use

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

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Tosoh Medic AIA Pack for FSH (K924863)

Submission Summary (Full Text)

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K964829
DEC 16 1996

# 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
[phone] extension 8413
Fax number: [phone]

Contact Person: Yvette Lloyd

Date Prepared: December 12, 1996 |
| 2. Device Name | Proprietary name: Elecsys CalCheck FSH

Common name: Calibration Verification Material

Classification name: Single (specified) analyte controls (assayed + unassayed) |
| 3. Predicate device | The Boehringer Mannheim Elecsys CalCheck FSH is substantially equivalent to the Tosoh Medic AIA Pack for FSH. (K924863) |
| 4. Device Description | The Boehringer Mannheim Elecsys CalCheck FSH are manufactured using human serum albumin, follicle stimulating hormone, and stabilizers. 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® FSH assay kit calibrators (prepared using a similar procedure). |

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# 510(k) Summary, Continued

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

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

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