A B-type natriuretic peptide (BNP) test is a diagnostic tool used to measure the levels of BNP in the blood. BNP is a hormone produced by the heart, particularly the ventricles, in response to pressure changes that occur when the heart is strained or overworked. This test is often used to help diagnose and assess the severity of heart failure.

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.

Intended Use: It is for in vitro diagnostic use in the quantitative determination of N‑terminal pro‑brain natriuretic peptide (NT‑proBNP) in human serum and plasma (EDTA and lithium heparin)

Device Description: Automated diagnostic device used for quantitative immunoassays, including the measurement of NT-proBNP (N-terminal pro-Brain Natriuretic Peptide) levels in human serum and plasma. This system is primarily used to aid in the diagnosis and assessment of heart failure. The test works by detecting light produced during a chemiluminescent reaction, where the HRP (Horseradish Peroxidase)-conjugated antibody binds to NT-proBNP in the sample, catalyzing the oxidation of a luminol derivative and generating light. It is specifically intended for in vitro diagnostic use and is regulated for prescription-only use, making it an essential tool for clinicians diagnose and assess the severity of heart failure in patients.

• Limit of Blank (LoB),
• Limit of Detection (LoD),
• Limit of Quantitation (LoQ)
• Linearity

The same is applicable for CE Marking under IVDR also.

Not Applicable for 510k submission and IVDR CE Marking