Who is the manufacturer of IMX FREE TRIIODOTHYRONINE (FREE T3)?

Abbott Laboratories filed the 510(k) submission for IMX FREE TRIIODOTHYRONINE (FREE T3) (K963833).

What is the FDA product code for IMX FREE TRIIODOTHYRONINE (FREE T3)?

CDP. It is classified under 21 CFR 862.1710 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for IMX FREE TRIIODOTHYRONINE (FREE T3)?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like IMX FREE TRIIODOTHYRONINE (FREE T3)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

Related Devices

K963827 — AXSYM FREE TRIIODOTHYRONINE (FREE T3) · Abbott Laboratories · Oct 30, 1996
K983439 — ABBOTT ARCHITECT FREE T3 · Abbott Laboratories · Nov 20, 1998
K960913 — ACCESS FREE T3 ASSAY · Bio-Rad Laboratories, Inc. · Mar 29, 1996
K983434 — ABBOTT ARCHITECT TOTAL T3 · Abbott Laboratories · Nov 20, 1998
K962355 — FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) · Bayer Corp. · Jul 12, 1996

Submission Summary (Full Text)

{0} 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 Attachment A Page 1 of 1