(112 days)
Immunoassay for the in vitro quantitative determination of N-terminal pro-Brain natriuretic peptide in human serum and plasma. The Elecsys proBNP Immunoassay is intended for use as an aid in the diagnosis of individuals suspected of having congestive heart failure.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys family of analyzers.
A device for the measurement of human proBNP in serum or plasma.
The provided text describes the Elecsys proBNP Immunoassay and its substantial equivalence to a predicate device, the Biosite Triage BNP Test. However, it does not contain a detailed study report that would typically outline acceptance criteria and prove the device meets them with specific performance metrics and study designs. Instead, it provides a comparison of features and general performance characteristics between the new device and the predicate.
Therefore, I cannot fully answer all points of your request based solely on the provided input. I will highlight what information is available and what is missing.
Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, pre-defined manner for clinical performance. Instead, it compares the Elecsys proBNP Immunoassay against a predicate device based on various features and analytical performance metrics. The implicit "acceptance" is based on demonstrating substantial equivalence to the legally marketed predicate device (Biosite Triage BNP Test, cleared under K003475).
Here's a table based on the provided comparison, highlighting analytical performance characteristics. It's crucial to note these are reported characteristics, not explicit acceptance criteria with pass/fail thresholds against which a study directly demonstrated compliance.
| Feature | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Elecsys proBNP Immunoassay) |
|---|---|---|
| Intended Use | Measurement of B-Type Natriuretic Peptide (BNP). | Quantitative determination of N-terminal pro-Brain natriuretic peptide. |
| Indication for Use | An aid in the diagnosis of congestive heart failure in patients age 55 and older. | An aid in the diagnosis of individuals suspected of having congestive heart failure. |
| Assay Protocol | Fluorescence Immunoassay | Electrochemiluminescent immunoassay |
| Measuring Range | 5-1300 pg/mL | 5-35,000 pg/mL |
| Precision | Within-run: 9.4-15.2 %CV (from 28.8-1080.4 pg/mL) | |
| Total: 10.1-16.2 %CV | E170: Within-run: 0.8-1.1 %CV (from 208-13,682 pg/mL); Total: 3.6-5.8% CV (from 200-13143 pg/mL) | |
| E1010/2010: Within-run: 1.8-2.7 %CV (from 175-4962 pg/mL); Total: 2.2-3.2 %CV (from 175-4962 pg/mL) | ||
| Hook Effect | NA (not mentioned for predicate) | No high dose hook effect up to 300,000 pg/mL |
| Analytical sensitivity (LDL) | 5 pg/mL | 5 pg/mL |
| Interference (Bilirubin) | No interference up to 20 mg/dL | No interference up to 35 mg/dL |
| Interference (Hemoglobin) | No interference up to 10000 mg/dL (severely hemolyzed specimens should be avoided) | No interference up to 1.4 g/dL |
| Interference (Triglycerides) | No interference up to 1000 mg/dL | No interference up to 4000 mg/dL |
| Interference (Cholesterol) | No interference up to 1000 mg/dL | NA (not mentioned for Elecsys proBNP) |
| Interference (Biotin) | NA (not mentioned for predicate) | No interference up to 30 ng/mL. Caution for high biotin doses (> 5 mg/dL) requiring sample collection 8 hours post-administration. |
| Interference (Rheumatoid Factor) | NA (not mentioned for predicate) | No interference up to 1500 IU/mL |
| Traceability/Standardization | Purified BNP preparation based on mass of analyte present in EDTA plasma. | Reference standard - purified synthetic NTG-proBNP (1-76) in human serum matrix. |
| Expected Values/Cut-offs | Age and sex-related descriptive statistics provided. Cut-off 100 pg/mL recommended. | Age and sex-related descriptive statistics provided. Cut-offs of 125 pg/ml for patients younger than 75 years and 450 pg/ml for patients 75 years and older are recommended. (Note: Different cut-offs indicate different analytes/assays, but both provide relevant clinical guidance). |
Study Details
The provided text does not contain a detailed study report that would include information on sample sizes, data provenance, expert ground truth, adjudication methods, or specific comparative effectiveness studies.
Based on the information available:
- Sample size used for the test set and the data provenance: Not explicitly stated. The document refers to "performance characteristics" and "limitations," implying studies were conducted to determine these, but it does not specify the number of samples or their origin.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is an immunoassay measuring a biomarker concentration, not an imaging device requiring expert interpretation for ground truth. The "ground truth" for analytical performance would be against known concentrations of the analyte or comparison to a reference method.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for this type of immunoassay.
- 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: Not applicable. This is an in vitro diagnostic (IVD) immunoassay, not an AI-powered diagnostic imaging device involving human readers or AI assistance.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device is a standalone immunoassay measuring ProBNP levels. Its performance is inherent to the assay itself.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this type of device, ground truth for analytical performance would typically be established by:
- Known concentrations: For precision, linearity, analytical sensitivity/detection limit.
- Spiking studies: For interference.
- Comparison to a gold standard or reference method: For accuracy and correlation.
- Clinical correlation: Showing the measured biomarker levels correlate with the presence or absence of congestive heart failure. The document indicates its use "as an aid in the diagnosis," suggesting clinical correlation studies formed part of its validation.
- The sample size for the training set: Not applicable. This is not a machine learning or AI device that uses training sets in the computational sense. Instead, the "training" for such a device involves developing and optimizing the assay reagents and protocols.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence of an immunoassay to an existing device. It highlights comparative features and analytical performance specifications rather than a detailed study report with specific acceptance criteria and clinical validation study designs.
§ 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.”