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The Quantimetrix Immusure Immunoassay/TDM Control is to be used as a quality control material to assess the accuracy and precision of laboratory test methods used to measure the serum analytes and therapeutic drugs contained in the control. It is intended to validate the measurement of these analytes and drugs in patient serum samples.

Quality Control materials having known component concentrations are an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method. CLIA regulation 493.1202(C)(4) requires labs to perform and document control procedures for each day of testing.

Three levels of control are provided to allow the performance of the analyte test methods to be monitored within the clinically significant range.

Immusure Assayed Immunoassay / TDM Controls are supplied in three levels, 6 x 5 mL each level per box and as a Tri-Level pack 6 vials 2 x 5 mL each level, as a ready-to-use liquid, requiring no reconstitution or dilution. They are prepared in a human serum matrix fortified to target levels with human and nonhuman source material and reagent grade chemicals added at different concentrations to achieve the three levels. Bacteriostatic and antifungal agents have been added as preservatives to inhibit microbial growth.

This document is a 510(k) premarket notification for a quality control material, not a medical device in the typical sense that uses AI or image analysis. Therefore, the questions related to AI performance, expert consensus, MRMC studies, and imaging data provenance are not applicable.

The document describes the Quantimetrix Immusure Assayed Chemistry Control, an immunoassay/TDM control intended for use as quality control material to assess the accuracy and precision of assay procedures for analytes.

Here's an analysis of the provided text based on the questions, noting where information is not applicable:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set (Stability Study): The document mentions "multiple lots of product" for ongoing real-time stability testing. However, it does not specify the exact number of lots or vials used in the accelerated stability study or the ongoing real-time study that informed the 3-year claim.
• Data Provenance: Not explicitly stated regarding the country of origin for the stability study data. The study involved accelerated aging and ongoing real-time testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. This device is a quality control material. Ground truth for its performance is established by analytical testing and comparison to reference values/initial values, not human expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. As a quality control material, the "acceptance" for stability is based on objective analytical measurements against a predefined criterion (percentage change in analyte recovery), not 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

• Not Applicable. This is a quality control material for laboratory assays, not an AI or imaging device involving human readers.

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

• Not Applicable. This is a quality control material, not an algorithm or AI device. Its performance is inherent to its chemical stability.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for the stability study was the initial analyte recovery values and the highest allowable instrument/reagent imprecision. Performance was evaluated by measuring changes in analyte recovery over time under specified storage conditions.

8. The sample size for the training set

• Not Applicable. This is a quality control material, not an AI model that requires a training set.

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

• Not Applicable. See point 8.

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