(31 days)
Abbott Laboratories Imx® Free T4
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No
The device description details a standard immunoassay method based on chemical reactions and optical measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is used for measuring free thyroxine (FT4) in human samples, which is a diagnostic function, not a therapeutic one. It provides information for diagnosis but does not treat or alleviate a condition.
Yes
The device quantitatively measures free thyroxine (FT4) in human serum and plasma, which is a diagnostic measurement used to assess thyroid function.
No
The device description clearly outlines a multi-step chemical and enzymatic immunoassay process involving physical components like chromium dioxide particles, magnetic separation, and color change measurement at a specific wavelength. This indicates a hardware-based system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used to "quantitatively measure free thyroxine (FT4) in human serum and heparinized plasma." This involves testing biological samples in vitro (outside the body) to provide information about a patient's health status.
- Device Description: The description details a laboratory assay process involving chemical reactions and measurements performed on a sample. This is characteristic of an in vitro diagnostic test.
- Performance Studies: The performance study compares the device's results to a predicate device using clinical patient samples, which is a standard practice for validating IVDs.
- Predicate Device: The mention of a predicate device (Abbott Laboratories Imx® Free T4) further confirms that this device is intended for the same diagnostic purpose as an existing IVD.
The core function of the device is to analyze a biological sample (serum or plasma) in a laboratory setting to diagnose or provide information about a medical condition (related to thyroid function, as indicated by the measurement of FT4). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The FT4 Method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module is used to quantitatively measure free thyroxine (FT4) in human serum and heparinized plasma.
Product codes
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Device Description
The FT4 assay is a two-step competitive enzyme immunoassav. Sample is incubated with chromium dioxide particles, coated with monoclonal antibodies specific for FT4 to form a particle/T4 complex. Particles are separated magnetically and the supernatant removed. The particle/T4 complex is incubated with conjugate reagent to react with unoccupied binding sites on the particles. Unbound conjugate is removed by washing. The bound alkaline phosphatase triggers an amplification cascade, resulting in the formation of a colored product. The color change measured at 510nm is inversely proportional to the concentration of free thyroxine present in the patient sample.
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
Split sample comparison between the The FT4 Method for the Dimension® RxL Clinical Chemistry System and the Abbott Imx® Free T4 assay gave a correlation coefficient of 0.968, slope of 0.963, and an intercept of 0.02 ng/dL when tested with 156 clinical patient samples.
Key Metrics
correlation coefficient of 0.968, slope of 0.963, and an intercept of 0.02 ng/dL
Predicate Device(s)
Abbott Laboratories Imx® Free T4
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1695 Free thyroxine test system.
(a)
Identification. A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the word "DADE" in large, bold, black letters. The font appears to be a sans-serif typeface. The letters are closely spaced, filling most of the frame.
APR 2 8 1997
Interoffice Memorandum
Summary of Safety and Effectiveness Information
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitter's Name: | Cathy P. Craft
Dade International Inc.
P.O. Box 6101
Newark, DE 19714-6101 |
|--------------------------|-------------------------------------------------------------------------------------|
| Date of Preparation: | March 27, 1997 |
| Name of Product: | FT4 Method for the Dimension® RxL Clinical
Chemistry System |
| FDA Classification Name: | Free Thyroxine Test System |
| Predicate Device: | Abbott Laboratories Imx® Free T4 |
Device Description: The FT4 assay is a two-step competitive enzyme immunoassav. Sample is incubated with chromium dioxide particles, coated with monoclonal antibodies specific for FT4 to form a particle/T4 complex. Particles are separated magnetically and the supernatant removed. The particle/T4 complex is incubated with conjugate reagent to react with unoccupied binding sites on the particles. Unbound conjugate is removed by washing. The bound alkaline phosphatase triggers an amplification cascade, resulting in the formation of a colored product. The color change measured at 510nm is inversely proportional to the concentration of free thyroxine present in the patient sample.
Intended Use: The FT4 Method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module is used to quantitatively measure free thyroxine (FT4) in human serum and heparinized plasma.
1
Comparison to Predicate Device:
| ltem | Dimension® RxL FT4 | Imx®Free T4 |
|---|---|---|
| Technology | Competitive format | |
| monoclonal antibody | ||
| immunoassay | Competitive format | |
| polyclonal antibody | ||
| immunoassay | ||
| Detection | Colorimetric endpoint | |
| measurement at 510nm | ||
| and 700nm | Fluorometric endpoint | |
| measurement |
Comments on Substantial
Equivalence: Split sample comparison between the The FT4 Method for the Dimension® RxL Clinical Chemistry System and the Abbott Imx® Free T4 assay gave a correlation coefficient of 0.968, slope of 0.963, and an intercept of 0.02 ng/dL when tested with 156 clinical patient samples.
Conclusion: The The FT4 Method for the Dimension® RxL clinical chemistry system is substantially equivalent in principle and performance to the Imx® Free T4 assay based on the split sample comparison discussed above.
Cay PCr H
ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
Cathy P. Craft Regulatory Affairs and Compliance Manager Date:March 27,1997