(24 days)
No
The summary describes a quantitative in vitro diagnostic assay for Free T3 using a specific immunoassay system. There are no mentions of AI, ML, image processing, or any other indicators of AI/ML technology. The performance studies focus on standard analytical metrics for an immunoassay.
No
The device is an in vitro diagnostic (IVD) method for quantitatively measuring Free T3 in human serum, used in the diagnosis and treatment of thyroid diseases. It is not directly used for treatment and thus is not a therapeutic device.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the measurements of Free T3 are "used in the diagnosis and treatment of thyroid diseases."
No
The device is an in vitro diagnostic (IVD) method intended to measure Free T3 in human serum on a specific system (Technicon Immuno-1). This implies the use of hardware components (the Immuno-1 system) for sample processing and analysis, 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 method is "in vitro" and is intended to measure Free T3 in human serum. This is a key characteristic of an IVD, as it involves testing samples taken from the human body outside of the body.
- Purpose: The intended use also states that the measurements are "used in the diagnosis and treatment of thyroid diseases." This diagnostic purpose is a core function of IVDs.
- Sample Type: The device analyzes "human serum," which is a biological sample commonly used in IVD testing.
- Performance Data: The document provides performance data such as correlation with a predicate device, minimum detectable concentration, precision, and cross-reactivity. This type of data is typically required for the validation and regulatory submission of IVD devices.
- Predicate Device: The mention of a "Predicate Device" (INCSTAR Clinical Assays "GammaCoat" Free T3 RIA kit) further confirms that this device is being compared to another IVD device already on the market.
All of these factors strongly indicate that this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This in vitro method is intended to quantitatively measure Free T3 in human serum on a Technicon Measurements of Free T3 are used in the diagnosis and treatment of thyroid Immuno-1 system. diseases.
Product codes
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Device Description
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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
Listed below is a comparison of the performance between the Immuno 1 Free T3 method and a similar device that was granted clearance of substantial equivalence (INCSTAR Clinical Assays "GammaCoat" Free T3 RIA kit). The information used in the Summary of Safety and Effectiveness was extracted from the Immuno 1 Free T3 method sheet and the Clinical Assays Free T3 Instruction Manual.
Minimum Detectable Conc.: Immuno 1 Free T3: 0.2 pg/mL, Clinical Assays: 0.02 pg/mL
Precision (Between-Run): Immuno 1 Free T3: 1.7 pg/mL 8.2%, 5.4 pg/mL 4.1%, 12.8 pg/mL 2.7%; Clinical Assays: 2.2 pg/mL 6.9%, 8.3 pg/mL 7.1%, 15.8 pg/mL 8.4%
Correlation: y = 0.95x - 0.08 where y = Immuno 1 Free T3 method, x = Clinical Assays Free T3 method, n = 103, r = 0.94, Svx = 0.71 'pg/mL
Key Metrics
Specificity (% Crossreactivity of ):
Diiodo-L-tyrosine: Immuno 1 Free T3:
§ 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
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SUMMARY OF SAFETY AND EFFECTIVENESS
Free T3 Method for Bayer Technicon Immuno 1® System
Listed below is a comparison of the performance between the Immuno 1 Free T3 method and a similar device that was granted clearance of substantial equivalence (INCSTAR Clinical Assays "GammaCoat" Free T3 RIA kit). The information used in the Summary of Safety and Effectiveness was extracted from the Immuno 1 Free T3 method sheet and the Clinical Assays Free T3 Instruction Manual.
INTENDED USED
This in vitro method is intended to quantitatively measure Free T3 in human serum on a Technicon Measurements of Free T3 are used in the diagnosis and treatment of thyroid Immuno-1 system. diseases.
| METHOD | Immuno 1 Free T3 | Clinical Assays
(predicate Device) |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Part No. | Reagents T01-3662-51
Calibrators T03-3663-01 | CA-1751 |
| Minimum Detectable Conc. | 0.2 pg/mL | 0.02 pg/mL |
| Precision (Between-Run) | 1.7 pg/mL
8.2%
5.4 pg/mL
4.1%
12.8 pg/mL
2.7% | 2.2 pg/mL
6.9%
8.3 pg/mL
7.1%
15.8 pg/mL
8.4% |
| Correlation | y = 0.95x - 0.08
where
y = Immuno 1 Free T3 method
x = Clinical Assays Free T3 method
n = 103
r = 0.94
Svx = 0.71 'pg/mL | |
1
SPECIFICITY
% Crossreactivity of :
| Immuno 1 Free T3 | Clinical Assays Free T3 | |
|---|---|---|
| Diiodo-L-tyrosine |