IMX FREE TRIIODOTHYRONINE (FREE T3)

K963833 · Abbott Laboratories · CDP · Oct 30, 1996 · Clinical Chemistry

Device Facts

• Record ID: K963833
• Device Name: IMX FREE TRIIODOTHYRONINE (FREE T3)
• Applicant: Abbott Laboratories
• Product Code: CDP · Clinical Chemistry
• Decision Date: Oct 30, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1710
• Device Class: Class 2

Intended Use

IMx Free T₃ is a microparticle enzyme immunoassay for the quantitative determination of free T₃ in human serum or plasma (lithium heparin, sodium heparin, or dipotassium EDTA).

Device Story

Microparticle enzyme immunoassay (MEIA) for quantitative free T₃ measurement; utilizes Abbott IMx Analyzer; input: human serum or plasma; output: quantitative free T₃ concentration (pg/mL); used in clinical laboratory settings by trained personnel; results assist clinicians in evaluating thyroid status; dynamic range 1.1-30.0 pg/mL.

Clinical Evidence

Bench testing only. Correlation study comparing IMx Free T₃ to Ciba Corning ACS Free T₃ using 767 specimens. Results: r=0.942, slope=1.14, standard error of estimate=0.783, Y-intercept=-0.47 pg/mL.

Technological Characteristics

Microparticle enzyme immunoassay (MEIA) technology; utilizes Abbott IMx Analyzer; calibrated with Abbott calibrators; verified with Abbott controls.

Indications for Use

Indicated for quantitative determination of free T₃ in human serum or plasma (lithium heparin, sodium heparin, or dipotassium EDTA) for clinical assessment of thyroid function.

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

• Ciba Corning Automated Chemiluminescence System (ACS) Free T₃ Immunoassay

Submission Summary (Full Text)

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K963833

OCT 0 1996

510(k) Summary Abbott IMx Free T₃

OCT 30 1996

# Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination

The following information as presented in the Premarket Notification for IMx® Free T₃ constitutes data supporting a substantially equivalent determination.

IMx Free T₃ is a microparticle enzyme immunoassay for the quantitative determination of free T₃ in human serum or plasma (lithium heparin, sodium heparin, or dipotassium EDTA). IMx Free T₃ is calibrated with Abbott calibrators. Abbott controls are assayed for the verification of the accuracy and precision of the Abbott IMx Analyzer.

Substantial equivalence has been demonstrated between the Abbott IMx Free T₃ assay and the Ciba Corning Automated Chemiluminescence System (ACS) Free T₃ Immunoassay. The intended use of both assays is for the quantitative determination of free T₃. IMx Free T₃ can be performed with human serum or plasma (lithium heparin, sodium heparin, or dipotassium EDTA). However, ACS Free T₃ can be performed on human serum only. A correlation analysis between these two assays, using 767 specimens, yielded a correlation coefficient of 0.942, slope of 1.14, standard error of estimate of 0.783, and Y-axis intercept of -0.47 pg/mL. The IMx Free T₃ assay has a dynamic range of 1.1-30.0 pg/mL, whereas the ACS Free T₃ assay has a dynamic range of 0.5-20.0 pg/mL.

In conclusion, these data demonstrate that the IMx Free T₃ assay is safe and effective, and is substantially equivalent to the Ciba Corning Automated Chemiluminescence System (ACS) Free T₃ Immunoassay.

Prepared and Submitted September 23, 1996 by:

Abbott Laboratories
Laura Granitz
Senior Regulatory Specialist
ADD Regulatory Affairs
Abbott Park, IL 60064

IMx Free T₃ 510(k)
September 1996
83510k.lwp
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