(77 days)
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.
| Feature | Acceptance Criteria (Elecsys proBNP K022516) | Reported Device Performance (Elecsys proBNP - add'l indication) |
|---|---|---|
| Precision | Within run: |
- 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.
§ 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.”