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.

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.

AI/ML Overview

This document describes the regulatory submission for the ACCESS® Free T3 assay, an in vitro diagnostic device, not a device that utilizes AI or machine learning. Therefore, many of the requested categories (e.g., sample size for the test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable.

Here's an analysis based on the provided text, focusing on the device's performance characteristics as an immunoassay:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance	Comments from Document
Precision	Within-run CV: 3.74% (high control) to 12.75% (low control)Total Imprecision CV: 5.08% (high control) to 13.42% (low control)	Ranges for Coefficient of Variation (CV) are provided for different control levels (low and high).
Correlation to Predicate Device	r = 0.929 (Pearson correlation coefficient)Equation: y = -1.09 + 1.33x (where y is ACCESS® Free T3 and x is Ciba Corning Magic® 1-Free T3)	This indicates a strong positive correlation and a linear relationship between the new device and the predicate.
Analytical Sensitivity	0.30 pg/mL	This is defined as the lowest detectable level of Free T3 distinguishable from zero with 95% confidence.

Note: The document does not explicitly state pre-defined "acceptance criteria" values (e.g., "r > 0.90 is acceptable"). Instead, it presents the results of the studies and concludes substantial equivalence based on these results.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: 217 samples were used for the correlation study comparing the ACCESS® Free T3 assay to the predicate device.
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It just states "217 samples."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is an in vitro diagnostic assay for quantitative measurement, not an AI device requiring expert interpretation for ground truth. The "ground truth" for the correlation study is the measurement obtained from the predicate device.

4. Adjudication method for the test set

Not applicable. This is an in vitro diagnostic assay. Measurements are quantitative, not subject to subjective adjudication in the way image interpretation might be.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an in vitro diagnostic assay, not an AI device intended to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is an in vitro diagnostic assay with a direct quantitative output, not an AI algorithm. Its "standalone" performance is described by its precision and analytical sensitivity.

7. The type of ground truth used

For the correlation study, the "ground truth" was essentially the measurements obtained from the predicate device (Ciba Corning Magic® 1-Free T3 assay), against which the new device's measurements were compared. For precision and analytical sensitivity, the ground truth is inherent to the assay's ability to measure known concentrations or differentiate from zero.

8. The sample size for the training set

Not applicable. This is a traditional immunoassay, not an AI/machine learning model that requires a "training set." The assay's parameters would have been developed through R&D, but not in the sense of an ML training set.

9. How the ground truth for the training set was established

Not applicable, for the same reasons as above.

Summary

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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

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

Regulation Number and Section

§ 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.