THYROID CALIBRATOR

K970389 · Dade Chemistry Systems, Inc. · JIT · Feb 18, 1997 · Clinical Chemistry

Device Facts

• Record ID: K970389
• Device Name: THYROID CALIBRATOR
• Applicant: Dade Chemistry Systems, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Feb 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Thyroid Calibrator is intended to be used on the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module to calibrate the FT4 and TSH methods.

Device Story

Liquid bovine albumin-based calibrator; contains thyroxine and human TSH (levels 2-5); level 1 contains no detectable thyroxine or TSH. Used on Dimension® RxL clinical chemistry system with heterogeneous immunoassay module. Provides reference points for calibrating FT4 and TSH assays. Used by laboratory personnel in clinical settings to ensure accuracy of patient thyroid hormone measurements.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Liquid bovine albumin matrix; 5-level kit; 2.0 mL per vial. Designed for use with Dimension® RxL clinical chemistry system.

Indications for Use

Indicated for use as a calibrator for FT4 and TSH methods on the Dimension® RxL clinical chemistry system.

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

• aca® plus FT4 Calibrator
• aca® plus TSH Calibrator

Submission Summary (Full Text)

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DADE
FEB 18 1997
K970389
Interoffice Memorandum

# Summary of Safety and Effectiveness Information

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Submitter's Name: Cathy P. Craft
Dade International Inc.
P.O. Box 6101
Newark, DE 19714-6101

Date of Preparation: 1/29/97

Name of Product: Thyroid Calibrator

FDA Classification Name: Calibrator

Predicate Device: aca® plus FT4 Calibrator and aca® plus TSH Calibrator

Device Description: The Thyroid Calibrator is a liquid bovine albumin based product. The Level 1 calibrator contains no detectable thyroxine or TSH. Levels 2 through 5 contain thyroxine and human TSH. The kit consists of ten vials; two at each of five levels.

Intended use: The Thyroid Calibrator is intended to be used on the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module to calibrate the FT4 and TSH methods.

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Comparison to Predicate
Device:

| Item | Thyroid Calibrator | aca® plus FT4 Calibrator | aca® plus TSH Calibrator |
| --- | --- | --- | --- |
| Intended Use | Calibrator | Calibrator | Calibrator |
| Analytes | thyroxine, TSH | thyroxine | TSH |
| Matrix | bovine albumin | human serum | horse serum |
| Form | liquid | lyophilized | lyophilized |
| Volume | 2.0 mL per vial | 3.0 mL per vial, reconstituted | 5.0 mL per vial, reconstituted |
| Levels | 5 levels | 3 levels | 3 levels |

Comments on Substantial

Equivalence: Both the Thyroid Calibrator and the aca® plus FT4 Calibrator are intended to be used as calibrators for free thyroxine methods. Both the Thyroid Calibrator and the aca® plus TSH Calibrator are intended to be used as calibrators for thyroid stimulating hormone methods.

Conclusion: The Thyroid Calibrator is substantially equivalent to the aca® plus FT4 Calibrator and the aca® plus TSH Calibrator for their respective analytes based on the comparison discussed above.


Cathy P. Craft
Regulatory Affairs and
Compliance Manager
Date: 1/29/97

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