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BGM Galectin-3 is an in vitro diagnostic device that quantitatively measures galectin-3 in serum or EDTA-plasma by enzyme-linked immunosorbant assay (ELISA) on a microtiter plate platform to be used in conjunction with clinical evaluation as an aid in assessing prognosis of patients diagnosed with chronic heart failure (HF). BGM Galectin-3 is indicated for prescription use only.

BGM Galectin-3 is a microtiter plate-based sandwich enzyme-linked immunosorbant assay (ELISA) for the quantitative determination of galectin-3 levels in human serum and plasma. BGM Galectin-3 consists of a rat monoclonal anti-mouse galectin-3 antibody coated microtiter plate serving as the solid phase capture antibody and a horseradish peroxidase (HRP)-labeled mouse monoclonal anti-human galectin-3 antibody functioning as the liquid phase tracer antibody for detecting bound galectin-3.

In the testing procedure, galectin-3 in the standard, control, or patient specimen binds to the immobilized capture antibody; after a wash step, bound galectin-3 is detected by the addition of HRP-labeled anti-galectin-3 antibody. Following a second wash step, the presence of bound galectin-3 is demonstrated by an enzymatic blue color development resulting from the addition of tetramethylbenzidene (TMB) solution as the substrate. Color development is stopped by adding sulfuric acid, changing the color to yellow. Color intensity is read at an absorbance of 450 nm using a colorimetric reader. The absorbance is proportional to the galectin-3 levels in the samples, and test results of the samples are determined using a calibration curve derived from the standards.

BGM Galectin-3 contains the microtiter plate, reagents, assayed quality control materials and standards required to perform analyses on serum or EDTA-plasma samples.

This document describes the analytical and clinical performance of the BGM Galectin-3™ assay.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for all tests in a single table, but the "Summary of Performance Data" section describes various tests and their outcomes. For clinical performance, the focus is on hazard ratios and cumulative probabilities.

Here's an integrated table derived from the provided text, using reported outcomes as evidence of meeting implicit acceptance criteria:

• All-cause mortality & hospitalization: 1.35-1.46 (p=0.004-0.006)
• Cardiovascular mortality: 1.91-2.33 (p=0.002- 25.9 ng/mL).

These two sets effectively serve as the "training" or "derivation" sets for the clinical interpretation of the assay.

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

• Reference Range: Established from 1,099 apparently healthy subjects. "Healthy" implies the absence of known heart disease. The exact methods for confirming "healthy" status are not detailed but would typically involve medical history, physical examination, and possibly other diagnostic tests.
• Cutoff Value Derivation: Derived from 582 individuals with HF. The document implies these cutoffs were determined by analyzing the association between galectin-3 levels and adverse outcomes within this derivation cohort. The specific methodology for deriving these cutoffs (e.g., statistical methods like ROC curve analysis or survival analysis) is not explicitly detailed in this summary, but they are subsequently validated in a separate, larger cohort. "HF" diagnosis would be established by clinical criteria, but the specific validation method for that diagnosis is not given.

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The Triage BNP test is intended for use with Beckman Coulter Immunoassay Systems (Access, Access 2, Synchron LXi 725 and UniCel Dxl 800) for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure). The test also is used for the risk stratification of patients with acute coronary syndromes and for the risk stratification of patients with heart failure.

The Triage® BNP test is intended for use with Beckman Coulter Immunoassay Systems (Access, Access 2, Synchron LXi 725 and UniCel Dxl 800) for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant.

The provided text is a 510(k) summary for the Triage BNP Test for the Beckman Coulter Immunoassay Systems. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than describing a new study with explicit acceptance criteria and performance data.

Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, ground truth establishment, and expert involvement are not present in the provided document. The document refers to prior 510(k) clearances and "various peer-reviewed publications" without detailing new studies.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices (K033383, K021317, K051787, R021011, R031170) based on identical principles, reagents, and procedures, rather than presenting new performance data against specific acceptance criteria.

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

This information is not present in the provided document. While it mentions "various peer-reviewed publications" describing the utility of BNP measurements, it does not detail a specific test set or its provenance for this submission.

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

This information is not present in the provided document.

4. Adjudication method for the test set

This information is not present in the provided document.

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

An MRMC study is not mentioned and is not relevant as this is a quantitative immunoassay device, not an imaging or AI-assisted diagnostic device where human reader performance would be a primary focus.

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

This is an in vitro diagnostic immunoassay. Its performance is inherently "standalone" in the sense that it provides a quantitative measurement. The document implies that the device's performance is demonstrated by its substantial equivalence to previously cleared devices, which would have undergone performance validation studies. However, the details of those specific studies are not provided in this document.

7. The type of ground truth used

This information is not explicitly stated for any new study in this document. For previous clearances of similar BNP tests, ground truth for diagnosis/assessment of heart failure would typically involve clinical diagnosis by cardiologists, imaging (e.g., echocardiography), and patient outcomes data regarding hospitalization or death. The document does state: "Higher BNP concentrations or the lack of a decrease in the BNP concentration from hospital admission to discharge indicate an increased risk of hospitalization or death in patients with heart failure," implying clinical outcomes as the ultimate ground truth for risk stratification.

8. The sample size for the training set

This information is not present as this is not an AI/Machine Learning device that would have a "training set" in that context. The device is a chemical immunoassay system.

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

Not applicable (see point 8).

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For the in vitro quantitative determination of N-terminal proBrain natriuretic peptide in human serum and plasma.

Elecsys proBNP is used as an aid in the diagnosis of individuals suspected of having congestive heart failure. The test is further indicated for the risk stratification of patients with acute coronary syndrome and congestive heart failure.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010, Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers

A device for the measurement of human proBNP in serum or plasma.

Here's a breakdown of the acceptance criteria and study information for the Elecsys® proBNP Immunoassay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as strict pass/fail thresholds in the provided document. Instead, the document presents a comparative analysis against a predicate device (Elecsys proBNP (K022516)) and another predicate for conceptual use (Triage BNP (K021317)). The "acceptance" is implied by demonstrating substantial equivalence to these legally marketed devices.

The table below summarizes the performance characteristics of the Elecsys proBNP (add'l indication) and compares them to the predicate devices. The "acceptance criteria" column reflects the performance of the primary predicate for the device.

• 0.9%CV @ 474 pg/mL
• 1.1%CV @ 8005 pg/mL
• 0.9%CV @ 13682 pg/mL
  Total:
• 5.8%CV @ 494 pg/mL
• 4.1%CV @ 7827 pg/mL
• 3.7%CV @ 13143 pg/mL
  E1010/2010 Within run:
• 2.7%CV @ 175 pg/mL
• 2.4%CV @ 355 pg/mL
• 1.9%CV @ 1068 pg/mL
• 1.8%CV @ 4962 pg/mL
  E1010/2010 Total:
• 3.2%CV @ 175 pg/mL
• 2.9%CV @ 355 pg/mL
• 2.6%CV @ 1068 pg/mL
• 2.3%CV @ 4962 pg/mL | Same as Elecsys proBNP (K022516) |
  | Hook Effect | No effect up to 300,000 pg/ml | No effect up to 300,000 pg/ml |
  | Analytical Sensitivity | 5 pg/mL | 5 pg/mL |
  | Limitations (Interference) | Bilirubin: No interference up to 35 mg/dL
  Hemoglobin: No interference up to 1.4 g/dL
  Triglycerides: No interference up to 4000 mg/dL
  Biotin: No interference up to 30 ng/mL
  Rheumatoid Factor: No interference up to 1500 IU/mL | Same as Elecsys proBNP (K022516) |
  | Measuring Range | 5-35,000 pg/mL | 5-35,000 pg/mL |

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

The provided 510(k) summary does not contain specific details about the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It mainly focuses on the performance characteristics and comparison to predicate devices, but the underlying study details are not present.

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 510(k) summary. For an in vitro diagnostic device, "ground truth" for performance studies typically comes from reference methods, clinical diagnosis, or patient outcomes, rather than expert consensus on images or similar data.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. Adjudication methods are more commonly described in studies where human interpretation of data is a variable (e.g., medical imaging studies).

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for devices involving human interpretation, especially AI-assisted diagnostic tools. The Elecsys proBNP Immunoassay is a laboratory-based immunoassay, not an AI-powered image analysis or interpretation tool.

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

Yes, the performance characteristics presented (precision, hook effect, analytical sensitivity, measuring range, limitations) represent the standalone performance of the immunoassay itself, without human-in-the-loop performance impacting the measurement results. The device quantifies a biomarker directly.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the performance characteristics described:

• Precision and Analytical Sensitivity: Ground truth is established by well-defined analytical methods using control materials or spiked samples with known concentrations.
• Hook Effect: Established by testing samples with extremely high concentrations to determine if the assay accurately reports or produces a falsely low result.
• Limitations (Interference): Established by testing samples spiked with known interferents at various concentrations.

For the clinical indications for use (aid in diagnosis of CHF, risk stratification for ACS and CHF), the underlying ground truth would be established through clinical diagnosis, patient outcomes, and potentially other diagnostic tests in clinical trials (which are not detailed in this 510(k) summary).

8. The Sample Size for the Training Set

This information is not applicable and is not provided. The Elecsys proBNP Immunoassay is a traditional immunoassay, not a machine learning or AI-based device that requires a "training set" in the computational sense. The assay is developed and validated through biochemical and analytical testing.

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

As noted above, this is not applicable for this type of device.

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