(36 days)
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No
The summary describes a standard immunoassay device and does not mention any AI or ML components or functionalities.
No.
The device is an in vitro diagnostic (IVD) immunoassay designed for quantitative determination of free T3 in human serum or plasma to aid in diagnosis, not to provide therapy.
Yes
The device is described as an "immunoassay for the quantitative determination of free T3 in human serum or plasma," which indicates its use in laboratory testing to provide diagnostic information.
No
The device description clearly states it is a microparticle enzyme immunoassay and mentions the use of an "Abbott IMx Analyzer," indicating it is a hardware-based laboratory assay system, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for the "quantitative determination of free T3 in human serum or plasma". This involves testing biological samples in vitro (outside the body) to provide information about a patient's health status.
- Device Description: The description confirms it is a "microparticle enzyme immunoassay", which is a common type of laboratory test performed on biological samples.
- Sample Type: It specifies the use of "human serum or plasma", which are biological fluids.
These characteristics clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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).
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.1710 Total triiodothyronine test system.
(a)
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.(b)
Classification. Class II. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
OCT - 0 1998 510(k) Summary CT 30 1996 Abbott IMx Free T3
Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
The following information as presented in the Premarket Notification for IMx® Free Ts 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 Ts assay and the Ciba Corning Automated Chemiluminescence System (ACS) Free Ts Immunoassay. The intended use of both assays is for the quantitative determination of free T3. IMx Free T2 can be performed with human serum or plasma (lithium heparin, sodium heparin, or dipotassium EDTA). However, ACS Free T2 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 ft3510k.lwp