(23 days)
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No
The summary describes a standard immunoassay system and does not mention any AI or ML components.
No
The device is an in vitro diagnostic assay used for quantitative determination of free triiodothyronine levels, aiding in diagnosis rather than providing direct therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The Access® Free T3 assay aids in the diagnosis of hyperthyroidism."
No
The device description explicitly states that the system comprises "reagents and the ACCESS® Immunoassay Analyzer," indicating the presence of hardware components (the analyzer) in addition to any potential software.
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 free triiodothyronine levels in human serum". This involves testing a biological sample (human serum) outside of the body (in vitro).
- Device Description: The description mentions "reagents" and an "Immunoassay Analyzer", which are typical components of an in vitro diagnostic system used to perform tests on biological samples.
- Performance Studies: The performance studies describe analytical characteristics like precision, correlation with another assay, and analytical sensitivity, which are relevant to the performance of an in vitro diagnostic test.
- Predicate Device: The mention of a "Predicate Device" which is another immunoassay (Magic® 1-Free T3 Radioimmunoassay) further confirms its classification as an IVD. Predicate devices are used in regulatory submissions for new IVDs to demonstrate substantial equivalence to a legally marketed device.
N/A
Intended Use / Indications for Use
The ACCESS® Free T3 assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum using the ACCESS® Immunoassay System. The Access® Free T3 assay aids in the diagnosis of hyperthyroidism.
Product codes
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Device Description
The ACCESS® Free T3 reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay System for the quantitative determination of free triiodothyronine in human serum.
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
human serum
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)
Precision studies: Within run precision ranges from 3.74% CV (high control) to 12.75% CV (low control). Total imprecision ranges from 5.08 % CV (high control) to 13.42 % CV (low control), Correlation: A comparison of Free T3 values from 217 samples run in both the ACCESS® Free T3 assay and the Ciba Coming Magic® 1-Free T3 assay test gives the following statistical data: r = 0.929, y = - 1.09 + 1.33x.
Analytical Sensitivity: The lowest detectable level of Free T3 distinguishable from zero (Free T3 Calibrator $0) with 95% confidence is 0,30 pg/ml.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 0.30 pg/ml (analytical)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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.
0
Sanofi
DIAGNOSTICS
Pasteur
Kx0913
APPENDIX D - Summary of Safety and Effectiveness Inform
1. General Information
Device Generic Name: Device Trade Name: Applicant's Name and Address:
Enzyme Immunoassay, Free T3 ACCESS® Free T3 assay Sanofi Diagnostics Pasteur. Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 (612) 448 - 4848 Katia Breslawec
MAR 29 1996
Contact:
2. Predicate Device
Magic® 1-Free T3 Radioimmunoassay Ciba Coming Diagnostics Corporation 63 North Street Medfield, MA 02052
3. Device Description
The ACCESS® Free T3 reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay System for the quantitative determination of free triiodothyronine in human serum.
4. Indications for Use
The ACCESS® Free T3 assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum using the ACCESS® Immunoassay System. The Access® Free T3 assay aids in the diagnosis of hyperthyroidism.
5. Comparison of Technological Characteristics
The ACCESS® Free T3 assay and the Ciba Coming Magic® 1-Free T3 assay are intended for the measurement of free triiodothryronine in human serum. The ACCESS® Free T3 assay and the Ciba Corning Magic® 1-Free T3 assay use multi-point calibrators/standards prepared in human serum. The ACCESS® Free T3 assay is non isotopic and uses a dioxetane based chemiluminescent substrate, while the Ciba Corning Magic® 1-Free T3 assay is a radioimmunoassay utilizing 1251 labeled triodothyronine. The ACCESS® Free T3 assay measures light production from a chemiluminescent reaction, while the Ciba Corning Magic® 1-Free T3 assay measures radioactivity. The ACCESS® Free T3 assay binds polyclonal capture antibody to paramagnetic particles, while the Ciba Corning Magic® 1-Free T3 assay binds polyclonal anti-T3 to microparticles. The ACCESS® Free T3 assay is a two step competitive binding immunoenzymatic assay, while the Ciba Corning Magic® 1-Free T3 assay is a one step competitive immunoassay.
6. Summary of Studies
Precision studies: Within run precision ranges from 3.74% CV (high control) to 12.75% CV (low control). Total imprecision ranges from 5.08 % CV (high control) to 13.42 % CV (low control), Correlation: A comparison of Free T3 values from 217 samples run in both the ACCESS® Free T3 assay and the Ciba Coming Magic® 1-Free T3 assay test gives the following statistical data: r = 0.929, y = - 1.09 + 1.33x.
Analytical Sensitivity: The lowest detectable level of Free T3 distinguishable from zero (Free T3 Calibrator $0) with 95% confidence is 0,30 pg/ml.
7. Conclusion
The ACCESS® Free T3 reagents when used with the ACCESS® Immunoassay Analyzer are substantially equivalent to another test for the measurement of Free T3 currently in commercial distribution.
Kallestad
Genetic Systems