AXSYM FREE TRIIODOTHYRONINE (FREE T3)

K963827 · Abbott Laboratories · CDP · Oct 30, 1996 · Clinical Chemistry

Device Facts

• Record ID: K963827
• Device Name: AXSYM 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

AxSYM 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 measurement of free T₃ in human serum or plasma; performed on Abbott AxSYM System; provides clinicians with thyroid status assessment; utilizes Abbott calibrators and controls for accuracy/precision verification.

Clinical Evidence

Bench testing only. Correlation study comparing AxSYM Free T₃ to Ciba Corning ACS Free T₃ using 745 specimens; results: r=0.948, slope=1.19, SEE=0.775, intercept=-0.96 pg/mL.

Technological Characteristics

Microparticle enzyme immunoassay (MEIA) technology; automated system; compatible with human serum, lithium heparin plasma, sodium heparin plasma, and dipotassium EDTA plasma.

Indications for Use

Indicated for quantitative determination of free T₃ in human serum or plasma (lithium heparin, sodium heparin, or dipotassium EDTA) to aid in the assessment of thyroid status.

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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KQ3827
OCT 30 1996

# 510(k) Summary
## Abbott AxSYM Free T₃

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

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

AxSYM 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). AxSYM Free T₃ is calibrated with Abbott calibrators. Abbott controls are assayed for the verification of the accuracy and precision of the Abbott AxSYM System.

Substantial equivalence has been demonstrated between the Abbott AxSYM 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. AxSYM 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 745 specimens, yielded a correlation coefficient of 0.948, slope of 1.19, standard error of estimate of 0.775, and Y-axis intercept of -0.96 pg/mL. The AxSYM 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 AxSYM 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 20, 1996 by:

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

AxSYM Free T₃ 510(k)
September 1996
aft510k.lwp
Attachment A
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