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Liquichek BNP Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for B-type Natriuretic Peptide (BNP).

Liquichek BNP Control is prepared from human serum with added constituents of human and animal origin, preservatives and stabilizers. The control is provided in liquid form.

This document describes a 510(k) premarket notification for the "Liquichek BNP Control" device. The acceptance criteria and supporting studies are focused on the device's stability and its intended use as a quality control serum for monitoring the precision of laboratory testing procedures for B-type Natriuretic Peptide (BNP).

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a separate "test set" in the context of clinical or diagnostic performance evaluation with patient samples. The studies discussed are related to the intrinsic stability of the control material itself. Therefore, sample sizes for a traditional test set or its provenance (country, retrospective/prospective) are not applicable or provided in this regulatory document.

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

Not applicable. This device is a quality control material, not a diagnostic device that requires expert-established ground truth from patient data. The "ground truth" for this product relates to its stability and consistency over time, which is determined through laboratory testing of the control material itself.

4. Adjudication method for the test set

Not applicable. As noted above, this is a quality control material, not a diagnostic device evaluated with patient samples requiring expert 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 device is a quality control material and is not an AI-powered diagnostic tool, nor does it involve human readers interpreting results in the context of AI assistance.

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

Not applicable. This device is a physical quality control serum, not a standalone algorithm.

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

For this quality control device, the "ground truth" for the stability studies would be defined by the expected stable concentration of BNP over time, under specified storage conditions. This is established through internal scientific methods and validated analytical procedures by the manufacturer (Bio-Rad Laboratories) using reference methods or internal standards to measure BNP concentration in the control material at various time points.

8. The sample size for the training set

Not applicable. This device is a manufactured control material undergoing stability testing, not a machine learning model requiring a training set.

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

Not applicable. There is no training set for this type of device.

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