THYROID STIMULATING HORMONE METHOD

K970393 · Dade Chemistry Systems, Inc. · JLW · Mar 3, 1997 · Clinical Chemistry

Device Facts

• Record ID: K970393
• Device Name: THYROID STIMULATING HORMONE METHOD
• Applicant: Dade Chemistry Systems, Inc.
• Product Code: JLW · Clinical Chemistry
• Decision Date: Mar 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1690
• Device Class: Class 2

Intended Use

The TSH method is used on the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module to quantitatively measure TSH in human serum and plasma. Measurements of TSH aid in the diagnosis of thyroid or pituitary disorders.

Device Story

One-step enzyme immunoassay for TSH quantification; performed on Dimension® RxL clinical chemistry system. Input: human serum/plasma sample. Process: sample incubated with CrO2 particles coated with anti-TSH monoclonal antibodies and ALP-labeled anti-TSH beta subunit antibodies; magnetic separation/washing removes unbound components. Sandwich-bound ALP triggers amplification cascade: dephosphorylates FADP to FAD; FAD activates APO d-amino acid oxidase; holo d-amino acid oxidase produces H2O2; HRP catalyzes reaction of DCHBS and 4-AAP to produce colored product. Output: absorbance measured at 510nm, proportional to TSH concentration. Used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing thyroid/pituitary disorders.

Clinical Evidence

Split-sample comparison of 86 clinical patient samples (range 0.04–49.21 μIU/mL) between Dimension® RxL TSH method and Abbott AxSYM® Ultrasensitive hTSH. Results: correlation coefficient 0.99, slope 1.06, intercept -0.03 μIU/mL.

Technological Characteristics

Sandwich enzyme immunoassay. Reagents: CrO2 particles, ALP-labeled monoclonal antibodies, FADP, APO d-amino acid oxidase, HRP, DCHBS, 4-AAP. Detection: colorimetric rate measurement at 510nm. System: Dimension® RxL clinical chemistry system with heterogeneous immunoassay module.

Indications for Use

Indicated for quantitative measurement of TSH in human serum and plasma to aid in the diagnosis of thyroid or pituitary disorders.

Regulatory Classification

Identification

A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

Predicate Devices

• Abbott AxSYM® Ultrasensitive hTSH

Submission Summary (Full Text)

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DADE
K970393
MAR - 3 1997
DADE INTERNATIONAL
Chemistry Systems
P.O. Box 6101
Newark, DE 19714

# 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:

Rebecca S. Ayash
Dade International Inc.
Building 500, Mailbox 514
P.O. Box 6101
Newark, DE 19714-6101

## Date of Preparation:

1/31/97

## Name of Product:

Thyroid Stimulating Hormone (TSH) Method

## FDA Classification Name:

Thyroid Stimulating Hormone Test System

## Predicate Device:

Abbott AxSYM® Ultrasensitive hTSH

## Device Description:

The TSH method is a one-step enzyme immunoassay. Sample is incubated with chromium dioxide particles (CrO₂) coated with monoclonal antibodies specific for the intact TSH molecule and conjugate reagent [alkaline phosphatase (ALP) labeled monoclonal antibodies specific for the TSH beta subunit] to form a particle/TSH/conjugate sandwich. Unbound conjugate and analyte are removed by magnetic separation and washing. The sandwich bound ALP initiates an amplification cascade. ALP dephosphorylates synthetic flavin adenine dinucleotide phosphate (FADP) to give FAD. FAD binds to APO d-amino acid oxidase and converts it to active holo d-amino acid oxidase. Each molecule of holo d-amino acid oxidase then produces multiple molecules of hydrogen peroxide (H₂O₂), which in the presence of horseradish peroxidase (HRP), converts 3,5-dichloro-2-hydroxybenzenesulfonic acid (DCHBS) and 4-aminoantipyrine (4-AAP) to a colored product that absorbs at 510nm. The color measured is directly proportional to the concentration of TSH present in the patient sample.

## Intended Use:

The TSH method is used on the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module to quantitatively measure TSH in human serum and plasma. Measurements of TSH aid in the diagnosis of thyroid or pituitary disorders.

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# Comparison to Predicate

## Device:

| Item | Dimension® RxL TSH Method | Abbott AxSYM® Ultrasensitive hTSH |
| --- | --- | --- |
| Technology | Sandwich format monoclonal antibody immunoassay | Sandwich format polyclonal/monoclonal antibody immunoassay |
| Detection | Colorimetric rate measurement at 577nm and 700nm | Fluorometric endpoint measurement |

## Comments on Substantial

**Equivalence:** Split sample comparison between the TSH method on the Dimension® RxL clinical chemistry system and the Abbott AxSYM® Ultrasensitive hTSH assay gave a correlation coefficient of 0.99, slope of 1.06 and an intercept of -0.03 μIU/mL when tested with 86 clinical patient samples ranging from ±0.04 to 49.21 μIU/mL.

**Conclusion:** The TSH method for the Dimension® RxL system with the heterogeneous immunoassay module is substantially equivalent in principle and performance to the Abbott AxSYM® Ultrasensitive hTSH Assay based on the split sample comparison summarized above.

Rebecca S. Ayash
Regulatory Affairs and
Compliance Manager
Date: 2/21/97