FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)

K962355 · Bayer Corp. · CDP · Jul 12, 1996 · Clinical Chemistry

Device Facts

• Record ID: K962355
• Device Name: FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
• Applicant: Bayer Corp.
• Product Code: CDP · Clinical Chemistry
• Decision Date: Jul 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1710
• Device Class: Class 2

Indications for Use

This in vitro method is intended to quantitatively measure Free T3 in human serum on a Technicon Immuno-1 system. Measurements of Free T3 are used in the diagnosis and treatment of thyroid diseases.

Device Story

The Immuno 1 Free T3 method is an in vitro diagnostic assay designed for use on the Technicon Immuno-1 system. It measures Free T3 concentrations in human serum samples. The device utilizes specific reagents and calibrators to perform the assay, providing quantitative results that assist clinicians in diagnosing and managing thyroid-related conditions. The system automates the measurement process, allowing for clinical laboratory use. Results are interpreted by healthcare providers to inform clinical decision-making regarding thyroid disease status and therapeutic monitoring.

Clinical Evidence

Bench testing only. Performance compared to predicate device using 103 serum samples. Correlation coefficient (r) = 0.94; regression equation y = 0.95x - 0.08. Precision (between-run) reported at three concentration levels (1.7, 5.4, 12.8 pg/mL) with CVs ranging from 2.7% to 8.2%. Minimum detectable concentration reported as 0.2 pg/mL. Specificity evaluated via cross-reactivity testing against 18 substances, including thyroid hormones and common medications.

Technological Characteristics

In vitro diagnostic immunoassay reagents and calibrators for use on the Technicon Immuno-1 system. Quantitative measurement of Free T3 in human serum. Specificity characterized by low cross-reactivity (<0.1% for most tested substances).

Indications for Use

Indicated for the quantitative measurement of Free T3 in human serum to aid in the diagnosis and treatment of thyroid diseases.

Regulatory Classification

Identification

A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.

Predicate Devices

• INCSTAR Clinical Assays™ GammaCoat™ Free T3 RIA kit

Submission Summary (Full Text)

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JUL 12 1996
K962355

# SUMMARY OF SAFETY AND EFFECTIVENESS

## Free T3 Method for Bayer Technicon Immuno 1® System

Listed below is a comparison of the performance between the Immuno 1 Free T3 method and a similar device that was granted clearance of substantial equivalence (INCSTAR Clinical Assays™ GammaCoat™ Free T3 RIA kit). The information used in the Summary of Safety and Effectiveness was extracted from the Immuno 1 Free T3 method sheet and the Clinical Assays Free T3 Instruction Manual.

## INTENDED USED

This *in vitro* method is intended to quantitatively measure Free T3 in human serum on a *Technicon Immuno-1* system. Measurements of Free T3 are used in the diagnosis and treatment of thyroid diseases.

| METHOD | Immuno 1 Free T3 | | Clinical Assays
(predicate Device) | |
| --- | --- | --- | --- | --- |
| Part No. | Reagents T01-3662-51 | | CA-1751 | |
| | Calibrators T03-3663-01 | | | |
| Minimum Detectable Conc. | 0.2 pg/mL | | 0.02 pg/mL | |
| Precision (Between-Run) | 1.7 pg/mL | 8.2% | 2.2 pg/mL | 6.9% |
| | 5.4 pg/mL | 4.1% | 8.3 pg/mL | 7.1% |
| | 12.8 pg/mL | 2.7% | 15.8 pg/mL | 8.4% |
| Correlation | y = 0.95x - 0.08
where | | | |
| | y = Immuno 1 Free T3 method | | | |
| | x = Clinical Assays Free T3 method | | | |
| | n = 103 | | | |
| | r = 0.94 | | | |
| | S_{yx} = 0.71 pg/mL | | | |

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# SPECIFICITY

% Crossreactivity of :

| | Immuno 1 Free T3 | Clinical Assays Free T3 |
| --- | --- | --- |
| Diiodo-L-tyrosine | <0.1 | <0.02 |
| 3-Iodo-L-tyrosine | <0.1 | <0.02 |
| Methimazole | 0.0 | N/R |
| Phenylbutazone | <0.1 | <0.02 |
| 6-n-Propyl-2-thyouracil | <0.1 | N/R |
| Tetraiodothyro-acetic acid | <0.1 | N/R |
| L-Thyroxine (T4) | <0.1 | <0.02 |
| D-Thyroxine | <0.1 | <0.02 |
| Ibuprofen | 0 | N/R |
| Phenobarbital | 0 | N/R |
| Phenytoin | 0 | N/R |
| Acetaminophen | 0 | N/R |
| 3,5 Diiodo-L-Thyronine | <0.1 | <0.02 |
| Acetyl Salicylic Acid | <0.1 | N/R |
| Heparinic Acid | <0.1 | N/R |
| L-3,3’5’Triiodo-Thyronine | 0.34 | N/R |
| Triiodothyroacetic acid | 0.37 | N/R |
| Fenoprofen | <0.1 | N/R |

N/R = Not Reported

Gabriel J. Muraca, Jr.
Manager Regulatory Affairs
Bayer Corporation
511 Benedict Avenue
Tarrytown, New York 10591-5097

7/3/96