ELECSYS CALCHECK TSH

K963147 · Boehringer Mannheim Corp. · JJX · Aug 23, 1996 · Clinical Chemistry

Device Facts

• Record ID: K963147
• Device Name: ELECSYS CALCHECK TSH
• Applicant: Boehringer Mannheim Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Elecsys CalCheck TSH is intended for use in the quantitative verification of the calibration curve established by the Elecsys TSH reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.

Device Story

Elecsys CalCheck TSH consists of three levels of lyophilized, human-based materials; used to verify calibration curves of TSH assays on Elecsys 1010 or 2010 immunoassay analyzers. User reconstitutes material, assays in triplicate on the analyzer, and compares results to target values. Provides quantitative verification of calibration accuracy; assists laboratory personnel in ensuring analyzer performance within clinical settings.

Clinical Evidence

No clinical data; bench testing only. Device performance verified by comparing triplicate assay results of reconstituted material against target values.

Technological Characteristics

Three-level lyophilized, human-based material. Designed for use with Elecsys 1010 or 2010 immunoassay analyzers. No specific materials of construction or software algorithms described.

Indications for Use

Indicated for use as a calibration verification material for TSH assays on Elecsys 1010 or 2010 immunoassay analyzers to verify the calibration curve.

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 Medic AIA-Pack HCG Calibration Verification Test Set (K924862)

Submission Summary (Full Text)

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K963147

AUG 23 1996

# 510(k) Summary

## Elecsys® CalCheck™ TSH

| 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
9115 Hague Rd.
Indianapolis, IN 46250
[phone]

Contact Person: John D. Stevens

Date Prepared: August 12, 1996 |
| 2) Device name | Proprietary name: Elecsys CalCheck TSH

Common name: Calibration Verification Material

Classification name: Single (specified) analyte controls (assayed + unassayed) |
| 3) Predicate device | We claim substantial equivalence to the Tosoh Medic AIA-Pack HCG Calibration Verification Test Set, K924862. The intended use for both products is to verify the calibration curve of automated immunoassay analyzers |
| 4) Device Description | The Elecsys CalCheck TSH is a three level single analyte set of lyophilized, human based materials. After reconstitution they are assayed in triplicate and the results are compared to the target values. |
| 5) Intended use | Elecsys CalCheck TSH is intended for use in the quantitative verification of the calibration curve established by the Elecsys TSH reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers. |

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# 510(k) Summary, Elecsys® CalCheck™ TSH, Continued

## 6) Comparison to predicate device

The Boehringer Mannheim Elecsys CalCheck TSH 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 HCG Calibration Verification Test Set, K924862.

The intended use of both the Elecsys CalCheck TSH and the predicate device are the same in that they are intended to be used for the calibration verification for their labeled analytes on automated immunoassay analyzers.