ACCESS FREE T3 ASSAY

K960913 · Bio-Rad Laboratories, Inc. · CDP · Mar 29, 1996 · Clinical Chemistry

Device Facts

• Record ID: K960913
• Device Name: ACCESS FREE T3 ASSAY
• Applicant: Bio-Rad Laboratories, Inc.
• Product Code: CDP · Clinical Chemistry
• Decision Date: Mar 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1710
• Device Class: Class 2

Intended Use

The ACCESS® Free T3 assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum using the ACCESS® Immunoassay System. The Access® Free T3 assay aids in the diagnosis of hyperthyroidism.

Device Story

ACCESS® Free T3 assay is a paramagnetic particle chemiluminescent immunoassay used with the ACCESS® Immunoassay Analyzer for quantitative determination of free triiodothyronine in human serum. Device operates as a two-step competitive binding immunoenzymatic assay. Input: human serum sample. Process: polyclonal capture antibody binds to paramagnetic particles; chemiluminescent reaction produces light measured by analyzer. Output: quantitative free T3 concentration. Used in clinical laboratory settings by trained personnel. Results aid clinicians in diagnosing hyperthyroidism by providing objective T3 levels.

Clinical Evidence

Bench testing only. Precision studies: within-run CV 3.74%-12.75%; total imprecision CV 5.08%-13.42%. Correlation study: 217 samples compared against predicate (r=0.929, y=-1.09+1.33x). Analytical sensitivity: 0.30 pg/ml (95% confidence).

Technological Characteristics

Paramagnetic particle chemiluminescent immunoassay. Two-step competitive binding immunoenzymatic assay. Dioxetane-based chemiluminescent substrate. Polyclonal capture antibody. System includes ACCESS® Immunoassay Analyzer. Non-isotopic.

Indications for Use

Indicated for quantitative determination of free triiodothyronine (T3) in human serum to aid in the diagnosis of hyperthyroidism.

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

• Magic® 1-Free T3 Radioimmunoassay (Ciba Corning Diagnostics Corporation)

Submission Summary (Full Text)

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SANOFI DIAGNOSTICS PASTEUR, INC.
1000 LAKE HAZELTINE DRIVE
CHASKA, MINNESOTA 55318-1084 U.S.A.
TEL: [phone]
s anofi
DIAGNOSTICS Pasteur
K960913

# APPENDIX D - Summary of Safety and Effectiveness Information

## 1. General Information

Device Generic Name: Enzyme Immunoassay, Free T3
Device Trade Name: ACCESS® Free T3 assay
Applicant's Name and Address: Sanofi Diagnostics Pasteur, Inc.
1000 Lake Hazeltine Drive
Chaska, MN 55318
(612) 448 - 4848
Contact: Katia Breslawec
MAR 29 1996

## 2. Predicate Device

Magic® 1-Free T3 Radioimmunoassay
Ciba Coming Diagnostics Corporation
63 North Street
Medfield, MA 02052

## 3. Device Description

The ACCESS® Free T3 reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay System for the quantitative determination of free triiodothyronine in human serum.

## 4. Indications for Use

The ACCESS® Free T3 assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum using the ACCESS® Immunoassay System. The Access® Free T3 assay aids in the diagnosis of hyperthyroidism.

## 5. Comparison of Technological Characteristics

The ACCESS® Free T3 assay and the Ciba Corning Magic® 1-Free T3 assay are intended for the measurement of free triiodothyronine in human serum. The ACCESS® Free T3 assay and the Ciba Corning Magic® 1-Free T3 assay use multi-point calibrators/standards prepared in human serum. The ACCESS® Free T3 assay is non isotopic and uses a dioxetane based chemiluminescent substrate, while the Ciba Corning Magic® 1-Free T3 assay is a radioimmunoassay utilizing $^{125}\mathrm{I}$ labeled triiodothyronine. The ACCESS® Free T3 assay measures light production from a chemiluminescent reaction, while the Ciba Corning Magic® 1-Free T3 assay measures radioactivity. The ACCESS® Free T3 assay binds polyclonal capture antibody to paramagnetic particles, while the Ciba Corning Magic® 1-Free T3 assay binds polyclonal anti-T3 to microparticles. The ACCESS® Free T3 assay is a two step competitive binding immunoenzymatic assay, while the Ciba Corning Magic® 1-Free T3 assay is a one step competitive immunoassay.

## 6. Summary of Studies

**Precision studies:** Within run precision ranges from $3.74\%$ CV (high control) to $12.75\%$ CV (low control). Total imprecision ranges from $5.08\%$ CV (high control) to $13.42\%$ CV (low control).

**Correlation:** A comparison of Free T3 values from 217 samples run in both the ACCESS® Free T3 assay and the Ciba Corning Magic® 1-Free T3 assay test gives the following statistical data: $r = 0.929$, $y = -1.09 + 1.33x$.

**Analytical Sensitivity:** The lowest detectable level of Free T3 distinguishable from zero (Free T3 Calibrator S0) with $95\%$ confidence is $0.30~\mathrm{pg / ml}$.

## 7. Conclusion

The ACCESS® Free T3 reagents when used with the ACCESS® Immunoassay Analyzer are substantially equivalent to another test for the measurement of Free T3 currently in commercial distribution.

Kalestad
Geretic Systens
DAGONISTICS PASTEUR
20