ELECSYS CALCHECK FT4

K963164 · Boehringer Mannheim Corp. · JJX · Aug 27, 1996 · Clinical Chemistry

Device Facts

• Record ID: K963164
• Device Name: ELECSYS CALCHECK FT4
• Applicant: Boehringer Mannheim Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Elecsys CalCheck FT4 is intended for use in the quantitative verification of the calibration curve established by the Elecsys FT4 reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.

Device Story

Elecsys CalCheck FT4 consists of three-level, lyophilized, human-based materials; used to verify calibration curves of automated immunoassay analyzers. User reconstitutes material; assays in triplicate; compares results to target values. Used in clinical laboratory settings by technicians/operators to ensure analyzer accuracy for FT4 testing.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Lyophilized, human-based material; three-level single analyte set; intended for use on Elecsys 1010 or 2010 immunoassay analyzers.

Indications for Use

Indicated for quantitative verification of calibration curves for FT4 reagents and calibrators on Elecsys 1010 or 2010 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 Medic AIA-Pack HCG Calibration Verification Test Set (K924862)

Submission Summary (Full Text)

{0}

K963164

AUG 27 1996

# 510(k) Summary

## Elecsys® CalCheck™ FT4

| 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 FT4

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 FT4 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 FT4 is intended for use in the quantitative verification of the calibration curve established by the Elecsys FT4 reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers. |

{1}

12

# 510(k) Summary, Elecsys® CalCheck™ FT4, Continued

## 6) Comparison to predicate device

The Boehringer Mannheim Elecsys CalCheck FT4 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 FT4 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.