(11 days)
The NTP method is an in vitro diagnostic assay for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human serum and plasma on the Dimension® EXLTM integrated chemistry system with LOCI® Module. In individuals suspected of having congestive heart failure (CHF), measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the risk stratification of patients with acute coronary syndrome and heart failure.
The EXL NTP method is a one-step sandwich chemiluminescent immunoassay based on LOCI® technology, LOCI® reagents include two synthetic bead reagents and a biotinylated monoclonal antibody fragment which recognize an epitope located in the N-terminal part of proBNP. The first bead reagent (Sensibeads) is coated with streptavidin and contains photosensitive dye. The second bead reagent (Chemibeads) is coated with a second antibody specific for a second independent epitope on NTproBNP and contains chemiluminescent dye. Sample is incubated with Chemibeads and biotinylated antibody to form a particle/NT-proBNP/biotinylated antibody sandwich. Sensibeads then are added and bind to the biotin to form a bead-aggregated immunocomplex. Illumination of the complex by light at 680 nm generates singlet oxygen from Sensibeads, which diffuses to the Chemibeads and triggers a chemiluminescent reaction. The resulting chemiluminescent signal is measured at 612 nm and is directly proportional to the concentration of NT-proBNP in the sample.
Here's a breakdown of the acceptance criteria and study information for the Dimension® EXL™ NTP Flex® Reagent Cartridge (RF623), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document establishes substantial equivalence by comparing the performance characteristics of the Dimension® EXL™ NTP Flex® Reagent Cartridge (RF623) to its predicate device, the Dimension Vista® PBNP Flex® reagent cartridge (K6423A). For each characteristic, the acceptance criterion is implicitly the performance of the predicate device, which the new device matches.
| Feature | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Dimension® EXL™ NTP Flex® RF623) |
|---|---|---|
| Intended Use | Quantitative measurement of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human serum and plasma for diagnosis and assessment of CHF severity, and risk stratification for acute coronary syndrome and heart failure. | Matches predicate's intended use (see detailed description in the document). |
| Device Technology | Chemiluminescent | Chemiluminescent |
| Measuring Range | 5 - 35,000 pg/mL | 5 - 35,000 pg/mL |
| Antibody | Monoclonal Sheep Antibody | Monoclonal Sheep Antibody |
| Cut-off | 125 pg/mL for |
§ 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.”