(360 days)
The Tosoh ST AIA-PACK BNP assay is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of BNP in human K2EDTA plasma on Tosoh AIA System analyzers. BNP is used as an aid in the diagnosis of heart failure (HF) in patients presenting to the emergency department (ED) with clinical suspicion of new onset HF, acutely decompensated or exacerbated HF.
The ST AIA-PACK BNP is a two-site immunoenzymometric assay which is performed entirely in the ST AIA-PACK BNP test cups. BNP present in the test sample is bound with monoclonal antibody immobilized on magnetic beads and enzyme-labeled monoclonal antibody. The magnetic beads are washed to remove unbound enzyme-labeled monoclonal antibody and are then incubated with a fluorogenic substrate, 4-methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the BNP concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using the curve.
The provided text describes the performance characteristics and clinical study results for the ST AIA-PACK BNP assay, an in vitro diagnostic device. This device is intended for the quantitative measurement of BNP in human K2EDTA plasma as an aid in the diagnosis of heart failure (HF).
Here's an analysis of the acceptance criteria and the study proving the device meets these criteria, based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a table format with pass/fail thresholds. Instead, it presents performance data from various analytical and clinical studies. We can infer performance parameters that would typically be subject to acceptance criteria in such a submission.
| Performance Characteristic | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Analytical Performance | ||
| Precision | CV% within acceptable range across various concentrations and sources of variation | Combined Lots (n=240): |
| K2EDTA Plasma-1 (mean 10.588 pg/mL): Total CV 10.8% | ||
| K2EDTA Plasma-2 (mean 49.873 pg/mL): Total CV 3.6% | ||
| K2EDTA Plasma-3 (mean 106.718 pg/mL): Total CV 3.0% | ||
| K2EDTA Plasma-4 (mean 519.429 pg/mL): Total CV 5.1% | ||
| K2EDTA Plasma-5 (mean 1050.712 pg/mL): Total CV 6.1% | ||
| (Detailed SD and CV% for within run, between run, between day, between lot are provided for each of 3 lots and combined data, generally showing good precision.) | ||
| Linearity/Reportable Range | Assay demonstrated to be linear over the stated range | Linear from 4.0 to 2000 pg/mL |
| Detection Limit (LoD) | LoD within acceptable clinical range | LoD = 1.9 pg/mL |
| Quantitation Limit (LoQ) | LoQ within acceptable clinical range | LoQ = 3.5 pg/mL |
| Analytical Specificity (Interference) | Interference due to common substances and cross-reactants |
§ 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.”