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Assayed controls for in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the measurement of the analytes listed in this package insert (ferritin, folate, and vitamin B12).

Device Description

The VITROS Immunodiagnostic System uses in human body fluids, commonly serum. semi-quantitative determination of selected analytics and statem semi-quantitative determination of hersen in the solid phase separation system.

The system is comprised of three main elements:

1. The VITROS Immunodiagnostic Products range of products in this case VITROS The VTROS Immunodiagnostic Products fallge of -propriments Products Calibrators Immunodiagnostic Products Reagent Pack, VITROS Immunodiagnostic Products assay Immunodiagnostic Products Reagent Fack, PFFNAS stices stic System to perform a VITROS assay. which are combined by the VITROS Immunodiagnostic System to perform a VITROS ass
1. The VITROS Immunodiagnostic System instrumentation, which provides automatical use of The VITROS Immunodiagnostic System - matimemation, Microp the immunoassay kits. The VITROS Immodiagnostic System was cleared for market by a reas and the VITROS Imments on 11 the immunoussay komarket notification (K962919).
1. Common reagents used by the VTROS System in each assay. The VTROS Immundiagnostic Same of the VTROS System in and in and in Products Universal Wash Rauent Common reagent and VITROS Immunodiagnostic Products Universal Wash Reagent Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Products Signal Products Signal Reagent and VITROS Immunodiagnostic Products Total T3 510(k) pre-market were cleared as part of the VITROS Immunodiagnostic Products Total T3 510(k) pre-marke notification (K964310).

The VITROS System and common reagents are dedicated specifically only for use with the The VITROS System and commond of immunoassay products.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in the way one might expect for a quantitative device performance study (e.g., "sensitivity must be >X%, specificity >Y%"). Instead, the core acceptance criterion for this 510(k) submission is Substantial Equivalence to a predicate device.

The reported device performance, in this context, is the demonstration of this substantial equivalence.

Acceptance Criterion	Reported Device Performance (as demonstrated by comparison)
Substantial Equivalence to Predicate Device (Bio-Rad Lyphochek® Immunoassay Plus Control levels 1, 2, and 3, K981532) in terms of:
- Intended Use	Similar: Both are intended for use in monitoring the performance of an immunoassay system for the measurement of selected analytes. The new device is specific to the VITROS System, while the predicate is a general assayed quality control serum.
- Matrix of controls	Different but Acceptable: New device: composed of buffer and horse serum, spiked with analytes. Predicate device: human serum with added constituents of human origin and pure chemicals. The FDA's clearance implies this difference in matrix did not impede substantial equivalence for safety and effectiveness.
- Control levels	Identical: Both offer Low, Medium, and High control levels.
- Expected values	Similar Approach: New device: mean value derived from a minimum of 10 assays and a standard deviation anticipated for singleton determinations across different labs and reagent batches; values are lot-specific. Predicate device: mean values and acceptable ranges printed in the insert, derived from replicate analyses, specific for that lot, performed by the reagent manufacturer and/or independent labs using manufacturer-supported reagents and a representative sampling of the lot. The methodologies for establishing expected values are similar in principle (replicate testing to establish lot-specific values).
Safety and Effectiveness	Reasonable assurance provided: "The data presented in the premarket notification provide a reasonable assurance that the VITROS Anemia Controls are safe and effective for the stated intended use." (This is the ultimate conclusion of meeting acceptance criteria for market clearance).

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

Sample Size: The document states that for the new device's expected values, a "minimum of 10 assays" were used to derive the mean value for each specific analyte. It also mentions "a number of different laboratories using different reagent batches." This indicates a test set, but not a single, combined sample size across all aspects. For the predicate device, it mentions "replicate analyses" and "a representative sampling of this control lot."
Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. Given the nature of a control material submission, the studies would typically be prospective during the product development and validation phase, taking place at the manufacturer's facility and potentially collaborating laboratories.

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

This type of information is generally not applicable to a quality control material. The "ground truth" for a control material is its assigned value and acceptable range, which is derived through rigorous analytical testing and statistical analysis of the material itself, not through expert interpretation of a clinical case.

4. Adjudication Method for the Test Set

Not applicable for a quality control material. Adjudication methods (like 2+1, 3+1) are used to reconcile discrepancies among human readers or expert reviewers in studies involving subjective interpretation (e.g., imaging, pathology). For a diagnostic control, the "truth" is established by analytical methods.

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 device is a quality control material, not an AI-powered diagnostic tool, and involves no human-in-the-loop interaction for interpretation in a clinical context.

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

Not applicable. This describes a quality control product, not an algorithm or AI.

7. The Type of Ground Truth Used

For a quality control material, the "ground truth" is the analytically derived mean values and acceptable ranges for each analyte within the control. This is established through:

Replicate analyses of the control material using accepted reference methods or the target diagnostic system.
Statistical analysis of these results to determine the mean and standard deviation.
Consideration of variability across different reagent batches and laboratory conditions.

8. The Sample Size for the Training Set

Not applicable. Training sets are relevant for machine learning algorithms. This device is a biochemical control material.

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

Not applicable. There is no concept of a "training set" or "ground truth for a training set" in the context of this device.

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