(27 days)
DPC COAT-A-COUNT TOTAL T3 RIA
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No
The device description details a standard competitive binding radioimmunoassay (RIA) which relies on chemical reactions and radioactive detection, not AI/ML algorithms. The performance study describes a linear regression analysis for method comparison, which is a statistical technique, not AI/ML. There are no mentions of AI, ML, or related concepts in the provided text.
No
The device is an in vitro diagnostic (IVD) assay designed to measure Total T3 in human serum for diagnostic purposes, not to provide therapy or treatment.
Yes
The device is described as an "RIA assay" and its intended use is for "the diagnosis and treatment of thyroid diseases such as hyperthyroidism," which clearly indicates a diagnostic purpose.
No
The device is a laboratory assay kit that utilizes a competitive binding protein assay with radiolabeled components and requires analysis in a gamma counter. This involves physical reagents and hardware, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is "intended for the quantitative determination of Total T3 in human serum." This is a classic description of an in vitro diagnostic test, as it involves analyzing a biological sample (human serum) outside of the body to obtain information for diagnosis and treatment.
- Device Description: The "Device Description" further clarifies that the kit is used for the "quantitative measurement of Total T3 in human serum" using a laboratory technique (RIA). This reinforces its nature as a diagnostic tool used in a laboratory setting.
- Purpose: The intended use also states that the measurement of T3 is used "in the diagnosis and treatment of thyroid diseases such as hyperthyroidism." This directly links the device's function to diagnostic purposes.
N/A
Intended Use / Indications for Use
The DSL ACTIVE™ T3 RIA assay is intended for the quantitative determination of Total T3 in human serum. The measurement of T3 is used in the diagnosis and treatment og thyroid diseases such as hyperthyroidism.
Product codes
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Device Description
The DSL ACTIVE™ T3 RIA kit was developed for the quantitative measurement of Total T3 in human serum. The RIA format is a competitive binding protein assay. Radiolabeled T3 competes with un-labeled T3 in the serum sample for binding sites to the antibody. Separation of free from bound T3 is achieved by decanting the coated tubes after incubation. The resultant is analyzed in a gamma counter for bounds counts per minute. The amount of radio-labeled T3 bound to the antibody is inversely proportional to the concentration of the T3 present in the 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
To demonstrate substantial equivalence between the two assays, patient samples (n=30) were collected and assayed using both methods. Samples were chosen based on expected T3 levels so that samples with low, intermediate and high levels would be evaluated. Linear regression analysis of the results obtained for the comparison gave the equation Y = 1.09(X) + -8.8 with a correlation coefficient of (r) = 0.90.
Key Metrics
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Predicate Device(s)
DPC COAT-A-COUNT TOTAL T3 RIA
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.
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Image /page/0/Picture/0 description: The image shows a stylized logo or symbol, featuring interconnected letters. The letters appear to be "d," "s," and "l," although the "s" is more abstract and formed by the negative space between the "d" and "l." The design is bold and monochromatic, with the letters rendered in black against a white background. The overall effect is modern and minimalist.
Diagnostic Systems Laboratories, Inc 445 Medical Center Boulevard Webster Texas 77598-4217 USA Tel 713.332.9678 Fax 713.554.4220
Customer Assistance Center Tel 800.231.7970 Fax 713.338.1895
SUMMARY OF SAFETY AND EFFECTIVENESS
DSL 3100 ACTIVE™ T3 RIA Kit Name of Device: Classification Name: Radioimmunoassay, Triiodothyronine Analyte Code and Name: Total Triiodothyronine Regulatory Class:
Submitter: John Willis Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Phone:713-332-9678
February 7, 1996 Date:
The DSL ACTIVE™ T3 RIA kit was developed for the quantitative measurement of Total T3 in human serum. The RIA format is a competitive binding protein assay. Radiolabeled T3 competes with un-labeled T3 in the serum sample for binding sites to the antibody. Separation of free from bound T3 is achieved by decanting the coated tubes after incubation. The resultant is analyzed in a gamma counter for bounds counts per minute. The amount of radio-labeled T3 bound to the antibody is inversely proportional to the concentration of the T3 present in the sample.
The DSL ACTIVE™ T3 RIA assay is intended for the quantitative determination of Total T3 in human serum. The measurement of T3 is used in the diagnosis and treatment og thyroid diseases such as hyperthyroidism.
The DSL ACTIVE™ T3 RIA is substantially equivalent to the DPC COAT-A-COUNT TOTAL T3 RIA.
To demonstrate substantial equivalence between the two assays, patient samples (n=30) were collected and assayed using both methods. Samples were chosen based on expected T3 levels so that samples with low, intermediate and high levels would be evaluated. Linear regression analysis of the results obtained for the comparison gave the equation Y = 1.09(X) + -8.8 with a correlation coefficient of (r) = 0.90.