(266 days)
The Access NT-proBNP assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of N-terminal pro B-type natriuretic peptide levels in human serum and plasma using the automated DxI Access Immunoassay Analyzers to aid in the following:
- diagnosis of patients suspected of having acute heart failure in the Emergency Department
- assessment of heart failure severity
- risk stratification of patients with heart failure
- risk stratification of patients with acute coronary syndrome
The Access NT-proBNP assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of N-terminal pro B-type natriuretic peptide levels in human serum and plasma using the automated Dxl 9000 Access Immunoassay Analyzers to aid in the following: 1) diagnosis of patients suspected of acute heart failure in the Emergency Department, 2) assessment of heart failure severity, 3) risk stratification of patients with heart failure, 4) risk stratification of patients with acute coronary syndrome.
The Access NT-proBNP is a two-site immunoenzymatic (sandwich) assay. Paramagnetic particles coated with monoclonal anti-NT-proBNP antibody and monoclonal anti-NTproBNP antibody conjugated to alkaline phosphatase are added to a reaction vessel along with a surfactant-containing buffer and serum or plasma sample. The human NTproBNP binds to the anti-NT-proBNP antibody on the solid phase, while the anti-NTproBNP antibody-alkaline phosphatase conjugate reacts with a different antigenic site on the NT-proBNP molecule. After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration.
Other items required to use the assay include calibrators, Lumi-Phos PRO, and wash buffer. The Access NT-proBNP reagent packs. Access NT-proBNP calibrators, along with the Access wash buffer, and Lumi-Phos PRO are designed for use on the Dxl 9000 Access Immunoassay Analyzers in a clinical laboratory setting.
Here's a breakdown of the acceptance criteria and study details for the Beckman Coulter Access NT-proBNP device, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the clinical and non-clinical studies conducted, with the device performance needing to meet expected ranges and exhibit substantial equivalence to predicate devices. Specific quantitative acceptance criteria are given for imprecision, LoB/LoD/LoQ, and linearity.
| Acceptance Criteria Category | Specific Criteria (Implied or Stated) | Reported Device Performance |
|---|---|---|
| Imprecision | - ≤ 4.0 ng/L SD at concentrations ≤ 50 ng/L |
- ≤ 8.0% CV at concentrations > 50 ng/L | Sample 1 (Mean 31 ng/L): SD 1.1 ng/L (3.5% CV). Meets criterion.
Sample 2 (Mean 129 ng/L): SD 7.8 ng/L (6.0% CV). Meets criterion.
Sample 3 (Mean 266 ng/L): SD 16.7 ng/L (6.3% CV). Meets criterion.
Sample 4 (Mean 377 ng/L): SD 26.4 ng/L (7.0% CV). Meets criterion.
Sample 5 (Mean 1,777 ng/L): SD 89.5 ng/L (5.0% CV). Meets criterion.
Sample 6 (Mean 12,076 ng/L): SD 676.7 ng/L (5.6% CV). Meets criterion.
Sample 7 (Mean 26,126 ng/L): SD 1516.1 ng/L (5.8% CV). Meets criterion. |
| High Dose Hook Effect | No observed high dose hook effect within a specified high concentration range (e.g., up to 300,000 pg/mL, similar to predicate) | No high dose hook effect observed up to 400,000 ng/L. Meets implied criterion (exceeds predicate device's demonstrated hook effect range). |
| Limit of Blank (LoB) | 50 ng/L - Within ± 5.0 ng/L for values ≤ 50 ng/L | Demonstrated acceptable non-linearity across the analytical measuring range (10.0 - 35,000 ng/L) and meets the specified ±10% and ±5.0 ng/L criteria. |
| Matrix Comparison | All indicated sample types (serum, lithium heparin plasma, EDTA plasma) are suitable for use. | Study with 68 matched samples showed all sample types are suitable. Meets criterion. |
| Interfering Substances | No significant interference (defined as > 10% shift in dose) by common substances at specified concentrations. | None of the tested compounds caused significant interference (>10% shift). Meets criterion. |
| Cross Reactivity | No significant cross-reactivity (>10%) with structurally similar substances. | No significant cross-reactivity (>10%) observed. Meets criterion. |
| Clinical Performance (AHF Diagnosis) | Aid in diagnosis of acute heart failure with comparable diagnostic accuracy to predicate device (Elecsys proBNP II), as evidenced by ROC AUC. | AUC for Access NT-proBNP was 0.8536 (95% CI: 0.8362 - 0.8710), comparable to Elecsys proBNP II at 0.8562 (95% CI: 0.8361 - 0.8762). Meets criterion of comparability. |
| Clinical Performance (NYHA Correlation) | Significant trend relationship between NT-proBNP values and NYHA classification for all subjects, females, and males. | JT test of trending resulted in statistically significant p-values (
§ 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.”