(74 days)
AxSYM ® BNP is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of human B-type natriuretic peptide in human EDTA plasma on the AxSYM System. BNP values are used as an aid in the diagnosis and assessment of severity of heart failure.
A device for the measurement of human B-Type Natriuretic Peptide (BNP) in EDTA plasma.
The Abbott AxSYM® B-Type Natriuretic Peptide (BNP) Microparticle Enzyme Immunoassay (MEIA) test was deemed substantially equivalent to the Biosite Triage BNP Test (K021317). The study conducted to demonstrate this equivalence compared the performance of the AxSYM BNP assay with the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation Coefficient (r) | 0.956 |
| Regression Slope (95% CI) | 1.12 (1.08 to 1.18) |
| Y-axis Intercept (95% CI) | -8 (-6 to -9) |
| Concordance at 100 pg/mL (95% CI) | 91.4% (87.7% to 94.2%) |
2. Sample Size and Data Provenance:
- Test Set Sample Size: 313 specimens.
- Data Provenance: The document does not specify the country of origin. It also does not explicitly state whether the data was retrospective or prospective, but the nature of the comparison study often implies prospectively collected samples for direct comparison.
3. Number and Qualifications of Experts for Ground Truth:
This study is a method comparison study comparing the performance of a new diagnostic device against a previously cleared predicate device, rather than assessing against a definitive clinical ground truth established by experts. Therefore, the concept of "experts used to establish ground truth" as it applies to subjective assessments (e.g., radiology interpretation) is not applicable here. The ground truth for the comparison was the result obtained from the predicate device (Biosite Triage BNP Test).
4. Adjudication Method:
Not applicable. As this was a method comparison study between two quantitative laboratory assays, there was no subjective interpretation or need for adjudication by experts in the test set. The comparison relied on direct numerical measurement concordance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This was not an MRMC study. It was a direct comparative effectiveness study between two diagnostic devices, not an assessment of human readers with or without AI assistance.
6. Standalone Performance:
Yes, in the context of a method comparison. The study evaluated the standalone performance of the AxSYM BNP assay by comparing its quantitative results against another standalone device (the Biosite Triage BNP Test). The results presented (correlation, slope, intercept, concordance) are measures of the AxSYM BNP assay's performance relative to the predicate, essentially demonstrating its "standalone" diagnostic output.
7. Type of Ground Truth Used:
The ground truth used was the results obtained from the predicate device, the Biosite Triage BNP Test (K021317). This is a form of device-to-device comparison where the previously cleared device serves as the reference standard.
8. Sample Size for the Training Set:
The document does not specify the sample size used for the training set. This information is typically proprietary to the manufacturer and not usually detailed in a 510(k) summary focused on substantial equivalence.
9. How the Ground Truth for the Training Set was Established:
The document does not provide details on how the ground truth for any training set might have been established. As a method comparison study proving substantial equivalence to a predicate, the focus is on the performance of the new device against the predicate, not on the internal development or training of the new device.
§ 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.”