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The Quantimetrix Dropper hsCRP High Sensivity CRP Control is intended for the quality control of laboratory testing procedures of high sensitivity C-Reactive protein (CRP). It is intended for professional in vitro diagnostic use only.

The Dropper® hsCRP Control is a ready-to-use liquid control that does not require reconstitution nor frozen storage. The product is supplied in three clinically significant levels filled to 1mL in convenient plastic dropper bottles. The controls are formulated in a human serum derived matrix fortified with preservatives and stabilizers to maintain product integrity and inhibit microbial growth. Each control level is formulated with human CRP antigen to clinically significant targets that are ideal to monitor high sensitivity CRP test methods.

This document describes the Quantimetrix Dropper® hsCRP High Sensitivity CRP Control (K152117), a quality control material.

Since this is a quality control material and not a diagnostic device intended to diagnose a condition, the acceptance criteria and study details are focused on the stability and performance of the control material itself, rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC, which are common for algorithms that interpret medical images or data.

1. Table of Acceptance Criteria and Reported Device Performance

Device: Quantimetrix Dropper® hsCRP High Sensitivity CRP Control

Study Proving Acceptance Criteria:
The document states that "Accelerated stability studies were conducted to establish the open and unopened stability claims. Accelerated stability studies were conducted to establish the shelf-life stability claim. Acceptance criteria were met to support the product claims." Additionally, "Real time stability studies are ongoing and performed for every lot."

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

The document does not specify a distinct "test set" in the context of evaluating diagnostic accuracy. Instead, the "testing" involves stability studies and value assignment.

• Stability Studies: The sample size for stability studies would refer to the number of control vials subjected to various storage conditions and time points. This detail is not explicitly provided in the document.
• Value Assignment: For value assignment, samples of a specific lot are submitted to "multiple laboratories and Quantimetrix laboratory" for testing across "different analyzer platforms." The sample size here relates to the number of vials per lot tested and the number of replicates performed. This specific number is not provided.
• Data Provenance: The data for value assignment comes from "interlaboratory and intralaboratory data using instrument manufacturer's reagents." The country of origin is not explicitly stated, but the submission is to the US FDA, implying testing relevant to the US market. The nature of these studies is prospective in the sense that they are specifically conducted to establish values for each lot and to determine stability.

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)

This concept does not apply directly to this device, as it is a quality control material, not a diagnostic algorithm interpreting data. The "ground truth" for the control material is its assigned value, which is determined through assaying the material using established laboratory methods.

• For Value Assignment: The "experts" involved are the personnel in the "multiple laboratories and Quantimetrix laboratory" who perform the testing. Their specific qualifications are not detailed, but they are expected to be trained laboratory professionals capable of running the hsCRP assays. No specific "number of experts" is given.

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

This concept typically applies to cases where multiple human readers are interpreting ambiguous medical images or data and need to reach a consensus. For a quality control material where analytical values are being determined, no formal adjudication method like 2+1 or 3+1 is mentioned or expected.

• Value Assignment: The "adjudication" is inherent in the "interlaboratory and intralaboratory data" where a mean value is calculated, and ranges are established (mean +/- 3SD). Outlier data might be identified and excluded statistically, but this is a statistical process, not a consensus among experts in the traditional sense.

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 MRMC comparative effectiveness study was done or is applicable. This type of study evaluates the impact of an AI algorithm on human reader performance, typically in diagnostic imaging. The Dropper® hsCRP High Sensitivity CRP Control is a quality control material, not an AI diagnostic algorithm, so this study type is irrelevant.

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

No standalone algorithm performance study was done or is applicable. This device is a physical control material used in laboratory testing procedures. It is not an algorithm.

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

For the value assignment of the control material, the "ground truth" is established by:

• Analytical Measurement: The measured concentrations of hsCRP in the control material, as determined by multiple analyses using established laboratory instruments and reagents (instrument manufacturer's reagents).
• Statistical Analysis: Calculation of a mean value and a standard deviation (specifically, a +/- 3SD range) from the collected analytical data.

For stability studies, the "ground truth" is that the assayed values of the control material remain within a predefined acceptable range (e.g., within the established mean +/- 3SD) over the tested duration under specified storage conditions.

8. The sample size for the training set

This concept is not applicable as this is not an AI/ML device that requires a training set.

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

This concept is not applicable as this is not an AI/ML device that requires a training set.

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