The Ciba Corning ASC FrT4 Immunoassay is a competitive immunoassay. FT4 in the-sample competes with the acridinium ester (AE-labeled T4 (Lite Reagent) for a limited amount of polyclonal rabbit anti-T4 antibody, which is covalently coupled to paramagnetic particles (solid phase). An indirect relationship exists between the FT4 in a sample and the relative light units (RLUs) detected.

AI/ML Overview

Here's an analysis of the provided information, focusing on acceptance criteria and the study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implied/Direct)	Reported Device Performance
Sensitivity	Minimum detectable concentration	0.1 ng/dl
	Upper detection limit	11.0 ng/dl
Accuracy	Correlation with reference method	r = 0.97
	Equation describing correlation	ACS FrT4 = 1.06 (RIA) - 0.33
Precision	Total % CV	2.81 to 4.65

Note: The document
does not explicitly state "acceptance criteria" but rather presents performance data. The table infers acceptance criteria based on the reported performance being considered acceptable for submission.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Accuracy Test: 74 samples.
Data Provenance: Not specified (country of origin, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The "ground truth" for the accuracy study appears to be a "RIA reference method assay," not expert adjudication.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. The accuracy was assessed by comparing the device's results to an "RIA reference method assay," not through human adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic immunoassay, not an AI-assisted diagnostic imaging device that involves human readers.

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

Yes, a standalone performance evaluation was done. The entire "Performance Data" section describes the quantitative output of the device itself (sensitivity, accuracy against a reference method, and precision) without involving a human in the loop for interpreting the results in a diagnostic context.

7. The Type of Ground Truth Used

The ground truth used for the accuracy assessment was a reference method assay, specifically an "RIA reference method assay."

8. The Sample Size for the Training Set

This information is not provided in the document. The document describes studies to validate the performance of the device, not the training of a machine learning model.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided. The device described is an immunoassay, not a machine learning model that requires a training set and corresponding ground truth.

Summary

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K961510

JUN 17 1996

Summary of Safety and Effectiveness

As required by 21 CFR 807.92, the following 510(k) Summary is provided:

1. Submitter Information

Contact person:

Thomas F. Flynn

Address:

Ciba Corning Diagnostics Corp. 63 North Street Medfield, MA 02052

508 359-3877 Phone: thomas.flynn@cibadiag.com e-mail:

Date Summary Prepared: April 19. 1996

2. Device Information

Proprietary Name: Common Name: Classification Name: ACS FrT4 Immunoassay FrT4 Immunoassay Class II, Free Thyroxine Test Kit. 21 CFR 862.1695

28342

3. Predicate Device Information

Name:	Amerlex-MAB FT4
Manufacturer:	Amerlex
510(k) Number:	Not Known

4. Device Description

5. Statement of Intended Use

For the quantitative determination of free thyroxine (FT4) in serum using the Ciba Corning Automated Chemiluminescence Systems.

6. Summary of Technological Characteristics

The Ciba Corning ACS FrT4 procedure is a competitive chemiluminescence immunoassay.

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7. Performance Data

Sensitivity

The ACS FrT4 immunoassay measures FT4 concentrations up to 11.0 ng/dl with a minimum detectable concentration of 0.1 ng/dl.

Accuracy

For 74 samples in the range of 0.62 to 4.26 ng/dl, the correlation between the ACS FrT4 immunoassay and the RIA reference method assay is described by the equation:

ACS FrT4 = 1.06 (RIA) - 0.33

Correlation coefficient (r) = 0.97

Precision

Total precision (Total % CV) ranged form 2.81 to 4.65.

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.