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The ARCHITECT BNP assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma on the ARCHITECT i System. BNP values are used as an aid in the diagnosis and assessment of severity of heart failure.

The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma. Refer to the ARCHITECT BNP reagent package insert and ARCHITECT i System for additional information.

The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System (reagents, calibrators, and instrument), when used for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma. Refer to the ARCHITECT BNP reagent package insert and ARCHITECT i System for additional information.

ARCHITECT BNP assay is a two-step immunoassay for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma using CMIA technology with flexible assay protocols, refereed to as Chemiflex®.

In the first step, sample and anti-BNP coated paramagnetic microparticles are combined. BNP present in the sample bind to the anti-BNP coated microparticles. After washing, anti-BNP acridinium-labeled conjugate is added to create a reaction mixture in the second step. Following another wash cycle pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of BNP in the sample and the RLUs detected by the ARCHITECT i System optics.

For additional information on system and assay technology, refer to the ARCHITECT System Operations Manual, Section 3.

Here's a breakdown of the acceptance criteria and study details for the ARCHITECT® BNP Assay based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria themselves are not explicitly stated as numerical targets (e.g., "correlation coefficient > 0.95"). Instead, the study aims to demonstrate substantial equivalence to the predicate device, the AxSYM BNP Assay, through strong correlation and a Passing-Bablok regression analysis indicating a close relationship (slope near 1, intercept near 0). The reported performance demonstrates this strong correlation.

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

• Sample Size: 171 individuals
• Data Provenance: The samples were collected from "populations of individuals with and without heart failure." No specific country of origin is mentioned, but the context implies it was likely collected from a clinical setting relevant to the US market where the submission is being made. The samples were EDTA plasma samples. The study is a single instance comparison, implying retrospective collection for this specific comparison study.

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 study compares the ARCHITECT BNP assay to a predicate device (AxSYM BNP assay), and the "ground truth" for the comparison is essentially the results obtained from the predicate device. Therefore, no external experts were used to establish a separate ground truth for the test set, beyond the established clinical use and validation of the predicate device itself.

4. Adjudication Method for the Test Set

This information is not applicable as the ground truth was based on comparison to the predicate device, not on independent expert adjudication of clinical outcomes or diagnoses.

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

This information is not applicable. The device is an in vitro diagnostic (IVD) assay for quantitative determination of a biomarker, not an AI-assisted diagnostic imaging or interpretation tool that involves human readers.

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

Yes, the study described is a standalone performance comparison between two assay devices (ARCHITECT BNP vs. AxSYM BNP). The ARCHITECT BNP assay is a laboratory test that provides quantitative results directly; it does not involve human interpretation in a human-in-the-loop scenario. The performance described (correlation, slope, intercept) is the direct output of the instrument.

7. The Type of Ground Truth Used

The "ground truth" for this study is the results obtained from the predicate device (ABBOTT AxSYM® B-Type Natriuretic Peptide (BNP) Microparticle Enzyme Immunoassay (MEIA) Test). The study aimed to demonstrate substantial equivalence to this legally marketed predicate device.

8. The Sample Size for the Training Set

This information is not provided as this document describes a comparison study, not the development or training of the ARCHITECT BNP assay itself. The ARCHITECT BNP is a chemiluminescent immunoassay, not a machine learning model that requires a "training set" in the conventional sense. The "training" of such a device primarily involves internal development, optimization, and calibration protocols which are generally not disclosed in typical 510(k) summaries for IVD devices.

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

This information is not provided and is not directly relevant to the type of device and the presented study. As mentioned above, the ARCHITECT BNP assay is a biochemical immunoassay, not an AI/ML device that requires a labeled "training set" with ground truth in the same way.

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