(61 days)
The Triage® BNP test is intended for use with the Beckman Coulter Immunoassay Systems (Access, Access 2, Synchron LXi 725, and UniCel Dxl Innianododay of closed of exemplement of B-Type Natriuretic Peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is used (GNP) in plainta eposis and assessment of severity of congestive heart failure. The test also is used for the risk stratification of patients with acute coronary syndromes.
The Triage BNP test for the Beckman Coulter Immunoassay Systems reagents consist of reagent packs, calibrators, QC, substrate and wash buffer. The test uses the same antibodies and calibrators traceable to the same BNP gold standard as the previously cleared Biosite Triage BNP Test.
This document describes a 510(k) summary for the Triage B-Type Natriuretic Peptide (BNP) Test for the Beckman Coulter Immunoassay Systems, submitted by Biosite Incorporated. The submission aims to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are demonstrated through its substantial equivalence to a previously cleared predicate device, the Biosite Triage BNP test. The key performance metric provided is the correlation with the predicate method.
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Analytical Performance | Method comparison with predicate showing strong correlation. | Passing-Bablok regression: slope of 1.00, intercept of -0.15, correlation coefficient of 0.95. |
| High agreement at a clinical cutoff (100 pg/mL). | At 100 pg/mL cutoff, 96.1% agreement with predicate. | |
| Equivalence to Predicate | Analytical performance characteristics equivalent to predicate. | "The analytical performance characteristics are equivalent to the predicate method..." |
| Interchangeability of results with predicate. | "...Triage BNP results can be used interchangeably." |
No specific numerical acceptance criteria (e.g., minimum correlation coefficient, minimum agreement) are explicitly stated in the provided text for the new device, beyond the demonstrated strong correlation and agreement with the predicate.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 412 EDTA plasma samples.
- Data Provenance: Not specified in the provided text. It is not mentioned if the data is from a specific country or if it is retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable for this submission. The "ground truth" in this context is established by the measurements obtained from the predicate device, not through expert consensus or interpretation of images/clinical cases. The study involves comparing the analytical measurements of two different immunoassay systems.
4. Adjudication Method for the Test Set
This information is not applicable for this type of analytical validation study. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where multiple experts independently review and judge ambiguous cases, often in radiology or pathology. Here, the "truth" for comparison is the measurement from a reference (predicate) method.
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 device is an in-vitro diagnostic (IVD) test for quantitative measurement of a biomarker, not an AI-powered diagnostic imaging or clinical decision support tool that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable in the context of an IVD immunoassay. The device itself is a "standalone" system in the sense that it performs the measurement. Its performance is evaluated analytically, not as an algorithm's interpretation that might require human oversight or input. The study compared the device (performing its measurement) to a predicate device (performing its measurement).
7. The Type of Ground Truth Used
The "ground truth" for this study was the measurements provided by the predicate device, the Biosite Triage BNP test. The study aimed to demonstrate that the new device's measurements correlated strongly and agreed with those of the already-cleared predicate device.
8. The Sample Size for the Training Set
This information is not provided and is likely not applicable in the conventional sense for this type of device. Immunoassays are typically developed and validated through a series of analytical studies (e.g., linearity, precision, interference, method comparison) rather than "training" using large datasets like machine learning models. The development likely involved internal studies to optimize reagents and assay parameters, but these are not referred to as a "training set" in the context of this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, the concept of a "training set" and "ground truth" establishment for it is not directly applicable here in the same way it would be for AI/ML models. The "ground truth" for developing and validating the assay (if conceptually mapped) would have been established through a combination of:
- Reference materials.
- Analytically defined samples (e.g., spiked samples, dilutions to establish linearity).
- Correlation with established laboratory methods and clinical samples during the development phase of the original Triage BNP test (the predicate), and then ensuring the new system maintains that performance.
The provided document specifically states: "The test uses the same antibodies and calibrators traceable to the same BNP gold standard as the previously cleared Biosite Triage BNP Test." This implies that the 'ground truth' or reference for the new device is ultimately the same 'gold standard' used for the predicate, ensuring consistency between the two.
§ 862.1117 B-type natriuretic peptide test system.
(a)
Identification. The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.(b)
Classification. Class II (special controls). The special control is “Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers.”