(44 days)
Not Found
Not Found
No
The description details a standard immunoassay method and mentions no AI/ML components or processes.
No
The device is an in vitro diagnostic (IVD) immunoassay designed to quantitatively measure free thyroxine (FT4) in human serum and plasma for diagnostic purposes, not to provide therapy.
Yes
The device measures free thyroxine (FT4) in human serum and plasma to provide quantitative results, which are used for diagnostic purposes.
No
The device description clearly outlines a chemical immunoassay process involving physical reagents, reaction vessels, and a discrete clinical analyzer (aca® plus). This is a hardware-based diagnostic 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 (serum and plasma) outside of the body to obtain diagnostic information.
- Device Description: The description details a laboratory assay process involving patient samples, reagents, and a clinical analyzer. This is characteristic of an in vitro diagnostic test.
- Performance Studies: The inclusion of performance studies comparing the device to a predicate device (Imx® Free T4 assay) using clinical patient samples further confirms its use in a diagnostic context.
Therefore, based on the provided information, the FT4 Method and the associated aca® plus immunoassay system are clearly intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The FT4 Method is used in the aca® plus immunoassay system to quantitatively measure free thyroxine (FT4) in human serum and heparinized plasma.
Product codes
Not Found
Device Description
The FT4 assay is a one-step competitive enzyme immunoassay. Patient sample is added by the aca® plus to a reaction vessel containing chromium dioxide particles coated with monoclonal antibodies specific for FT4 and T3-alkaline phosphatase conjugate reagent. A particle/ FT4/ conjugate sandwich forms during an incubation period. The sandwich is washed to remove any unbound conjugate. The mixture is resuspended and the sandwich is transferred by the aca® plus to an FT4 test pack. The FT4 test pack is then placed into an aca® discrete clinical analyzer.
The bound alkaline phosphatase triggers an amplification cascade, resulting in the formation of a colored product. The color change measured at 510nm is directly proportional to the concentration of free thyroxine present in the patient sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Split sample comparison between the aca® plus FT4 Method and the Imx® Free T4 assay gave a correlation coefficient of 0.9076, slope of 0.94, and an intercept of 0.16 when tested with 146 clinical patient samples.
Key Metrics
Not Found
Predicate Device(s)
Abbott Laboratories IMX® Free T4
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the word "DADE" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The letters are evenly spaced and aligned horizontally.
AUG 1 5 1999
Image /page/0/Picture/2 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the digits '9', '6', '2', '6', '0', and '2'. The digits are written in a cursive style, with some connections between them.
DADE INTERNATIONAL
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: | 6/28/96 |
| Name of Product: | aca® plus Free Thyroxine (FT4) Method |
| FDA Classification Name: | Free Thyroxine Test System |
| Predicate Device: | Abbott Laboratories IMX® Free T4 |
Device Description: The FT4 assay is a one-step competitive enzyme immunoassay. Patient sample is added by the aca® plus to a reaction vessel containing chromium dioxide particles coated with monoclonal antibodies specific for FT4 and T3-alkaline phosphatase conjugate reagent. A particle/ FT4/ conjugate sandwich forms during an incubation period. The sandwich is washed to remove any unbound conjugate. The mixture is resuspended and the sandwich is transferred by the aca® plus to an FT4 test pack. The FT4 test pack is then placed into an aca® discrete clinical analyzer.
The bound alkaline phosphatase triggers an amplification cascade, resulting in the formation of a colored product. The color change measured at 510nm is directly proportional to the concentration of free thyroxine present in the patient sample.
Intended Use: The FT4 Method is used in the aca® plus immunoassay system to quantitatively measure free thyroxine (FT4) in human serum and heparinized plasma.
1
Comparison to Predicate Device:
| Item | aca® plus FT4 | IMx® Free T4 |
|---|---|---|
| Technology | Competitive format | |
| monoclonal antibody | ||
| immunoassay | Competitive format | |
| polyclonal antibody | ||
| immunoassay | ||
| Detection | Colorimetric endpoint | |
| measurement at 510nm | ||
| and 600nm | Fluorometric endpoint | |
| measurement |
Comments on Substantial
Split sample comparison between the aca® plus FT4 Equivalence: Method and the Imx® Free T4 assay gave a correlation coefficient of 0.9076, slope of 0.94, and an intercept of 0.16 when tested with 146 clinical patient samples.
The aca® plus FT4 Method is substantially equivalent in Conclusion: principle and performance to the IMx® Free T4 Assay based on the split sample comparison discussed above.
$\tau^{n_2}, P(r/t$
Cathy P. Craft Regulatory Affairs and Compliance Manager Date: