ELECSYS PRECICONTROL TSH

K962573 · Boehringer Mannheim Corp. · JJX · Jul 22, 1996 · Clinical Chemistry

Device Facts

• Record ID: K962573
• Device Name: ELECSYS PRECICONTROL TSH
• Applicant: Boehringer Mannheim Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jul 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Control for Thyroid Stimulating Hormone assays.

Device Story

Elecsys® PreciControl TSH; liquid horse serum albumin control containing recombinant TSH; used to monitor performance of TSH assays on Elecsys® 2010 system; provides quality control verification for clinical laboratory TSH testing; standardized against WHO-reference material #80/558; stored at 2-8°C; open vial stability of 4 weeks.

Clinical Evidence

No clinical data. Bench testing only; performance characteristics established via comparison of stability and value assignment against predicate device.

Technological Characteristics

Liquid horse serum albumin matrix; contains recombinant TSH; standardized to WHO-reference material #80/558; storage 2-8°C; 4-week open vial stability; designed for Elecsys® 2010 test system.

Indications for Use

Indicated for use as a quality control material for monitoring Thyroid Stimulating Hormone (TSH) assays.

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

• Elecsys® TSH CalSet (K961491)

Submission Summary (Full Text)

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K962573
JUL 22 1996
Diagnostics

# 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]

Contact Person: Patricia Klimley
Date Prepared: June 26, 1996

## 2. Device name

Proprietary name: Elecsys® PreciControl TSH Assay
Common name: Control material
Classification name: Enzyme controls (Assayed and Unassayed)

## 3. Predicate device

The Boehringer Mannheim Elecsys® PreciControl TSH is substantially equivalent to the Elecsys® TSH CalSet (K961491). The intended use has been changed to a quality control material.

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Diagnostics

# 510(k) Summary, Continued

4. Device Description
Horse serum albumin control with recombinant Thyroid Stimulating Hormone for use in TSH assays.

5. Intended use
Control for Thyroid Stimulating Hormone assays.

6. Comparison to predicate device
The Boehringer Mannheim Elecsys® PreciControl TSH is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the Elecsys® TSH CalSet (K961491).

The following table compares the Elecsys® PreciControl TSH with the predicate device, Elecsys® TSH CalSet.

## Similarities:
- Same formulation.
- Same matrix: Horse serum matrix
- Same analyte: recombinant Thyroid Stimulating Hormone
- Standardization: World Health Organization (WHO-reference material # 80/558)
- Storage conditions: 2 - 8°C
- Application test system: Elecsys® 2010
- Reconstitution: none required, liquid
- Open vial stability: 4 weeks at 2 - 8°C
- Manufacturer: Boehringer Mannheim Germany

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510(k) Summary, Continued

Diagnostics

## 6. Comparison to predicate device cont.

### Differences:

| Feature | Elecsys® TSH CalSet | Elecsys® PreciControl TSH |
| --- | --- | --- |
| Target concentration | 0 and 1.4μU/mL | 0.18 μU/mL |
| Intended Use | Calibration of the Elecsys TSH Assay | Monitoring assays for TSH |

### Performance Characteristics:

| Feature | Elecsys® TSH CalSet | Elecsys® PreciControl TSH |
| --- | --- | --- |
| Open Vial Stability | 4 weeks at 2 - 8°C | 4 weeks at 2 - 8°C |
| Value Assignment | standardized against WHO-reference material (#80/558) | standardized against WHO-reference material (#80/558) |

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