(50 days)
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No
The description details a standard enzyme immunoassay (EIA) process which relies on chemical reactions and spectrophotometry, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is an immunoassay kit used for quantitative determination of T3 in human serum or plasma, which is a diagnostic purpose, not a therapeutic one.
Yes
Explanation: The device is an "Enzyme Immuno-assay test for the quantitative determination of Triodothyronine (T3) in human serum," which is a measurement used to aid in disease diagnosis or management.
No
The device description clearly outlines a physical immunoassay kit involving microwells, antibodies, enzyme conjugates, and a chromogen substrate, which are all hardware components. The measurement is done using a microtiter reader, also a hardware device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of Triodothyronine (T3) in human serum." This is a test performed on a biological sample (serum) outside of the body to provide information about a person's health status.
- Device Description: The description details a laboratory-based assay (Enzyme Immuno-assay) that uses reagents and a microtiter plate to measure a substance (T3) in a biological sample. This is characteristic of an in vitro diagnostic test.
- Sample Type: The test is performed on "human serum or plasma," which are biological specimens.
The definition of an IVD is a medical device that is used to examine specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly fits that definition.
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Intended Use / Indications for Use
Biomerica's T3 microwell EIA is Enzyme Immuno-assay test for the quantitative determination of Triodothyronine (T3 ) in human serum.
Product codes
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Device Description
Biomerica's T3 EIA is a sensitive solid phase enzyme immunoassay system for the quantitative determination of T3 in patient serum or plasma. Specific antibodies to T3 are immobilized on the inside surface of microwells of microtiter plate (96). A known volume of serum or plasma containing T3 and an enzyme labeled T3 conjugate are added to the antibody coated microwells. Both the T3 in the sample and the enzyme conjugated T3 compete for a limited number of binding sites available on the antibody. The unbound T3-enzyme conjugate is washed off from the microwells. A chromogen substrate mixture is added to the bound T3 enzyme conjugate to develop color. The intensity of the color developed is measure by the microtiter reader and is inversely proportional to the amount of T3 present in the patient's sample. The quantity of T3 present in the patient's sample (serum or plasma) is measured by extrapolating from the dose response curve (DRC) .
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)
The performance data and clinical data is on file and is available to any qualified individual upon request.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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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.
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510 (K) Summary Statement
To The Reviewer:
Biomerica's T3 microwell EIA is Enzyme Immuno-assay test for the quantitative determination of Triodothyronine (T3 ) in human serum. This test is substantially equivalent to T3 Coat-a- Count RIA test ( DPC kit ) for the quantitative determination of T3 in human serum.
This device is an in vitro diagnostic test kit.
Biomerica's T3 EIA is a sensitive solid phase enzyme immunoassay system for the quantitative determination of T3 in patient serum or plasma. Specific antibodies to T3 are immobilized on the inside surface of microwells of microtiter plate (96). A known volume of serum or plasma containing T3 and an enzyme labeled T3 conjugate are added to the antibody coated microwells. Both the T3 in the sample and the enzyme conjugated T3 compete for a limited number of binding sites available on the antibody. The unbound T3-enzyme conjugate is washed off from the microwells. A chromogen substrate mixture is added to the bound T3 enzyme conjugate to develop color. The intensity of the color developed is measure by the microtiter reader and is inversely proportional to the amount of T3 present in the patient's sample. The quantity of T3 present in the patient's sample (serum or plasma) is measured by extrapolating from the dose response curve (DRC) .
DRC is prepared by plotting known concentrations of T3 on X-axis and the corresponding color absorbance on Y-axis, using a semi-log graph sheet or a Software program for microtiter plate reader.
Data submitted in this 510 (K) premarket notification is correct and has been compared to be substantially equivalent to a 510 (K) cleared commercially available predicate device ( DPC RIA kit ) in the market.
The performance data and clinical data is on file and is available to any qualified individual upon request. Biomerica is responsible for all of the information
submitted which is true and authentic to the best of our knowledge.
Sincerely,
Perry G. Rucker
Manager, Regulatory Affairs
Дор Н. Дані
Joseph H. Irani President
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