(36 days)
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No
The summary describes a standard immunoassay device and does not mention any AI or ML components.
No
The device is described as a quantitative determination assay, which is a diagnostic tool, not a therapeutic intervention.
Yes
The "Intended Use" explicitly states "for the quantitative determination of free Ts in human serum or plasma," which is a measurement used to aid in diagnosing conditions related to thyroid function.
No
The device description explicitly states it is a "microparticle enzyme immunoassay" and is used with the "Abbott AxSYM System," indicating it is a hardware-based immunoassay system, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the quantitative determination of free Ts in human serum or plasma". This indicates that the device is used to analyze biological samples (serum or plasma) in vitro (outside the living body) to obtain diagnostic information (the level of free Ts).
- Device Description: The description details a "microparticle enzyme immunoassay," which is a common type of laboratory test performed on biological samples. It also mentions the use of calibrators and controls, which are standard components of IVD systems for ensuring accuracy and precision.
- Performance Studies: The description of performance studies, including correlation analysis with another assay and dynamic range, are typical evaluations performed for IVD devices to demonstrate their analytical performance.
The core function of analyzing biological samples in vitro to provide quantitative results for diagnostic purposes clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
"for the quantitative determination of free T3 in human serum or plasma (lithium heparin, sodium heparin, or dipotassium EDTA)."
Product codes
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Device Description
"AxSYM Free T2 is a microparticle enzyme immunoassay for the quantitative determination of free Ts 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."
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
"A correlation analysis between these two assays, using 745 specimens, vielded 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."
Key Metrics
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Predicate Device(s)
Ciba Corning Automated Chemiluminescence System (ACS) Free T3 Immunoassay
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
Ka3887
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 T2 is a microparticle enzyme immunoassay for the quantitative determination of free Ts 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 Ts 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, vielded 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 aft3510k.hwp
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