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The Dade Behring Dimension® PBNP Flex® reagent cartridge method is an in vitro diagnostic assay for the quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human plasma. Measurements of NT-proBNP are used as an aid in the diagnosis of individuals suspected of having congestive heart failure.

The Dade Behring Dimension® PBNP Calibrator is intended to be used to calibrate the N-terminal pro-brain natriuretic peptide (PBNP) method for the Dade Behring Dimension® clinical chemistry system.

The Dade Behring Dimension® NT-proBNP (PBNP) Flex® reagent cartridge method is an in vitro diagnostic test that consists of prepackaged reagents in a flexible plastic cartridge for use only on the Dimension® clinical chemistry system. The PBNP method is a one step enzyme immunoassay based on the "sandwich" principle. Sample is incubated with chromium dioxide particles coated with polyclonal antibodies which recognize an epitope located in the N-terminal part of proBNP, and a conjugate reagent [alkaline phosphatase (ALP)] labeled polyclonal antibody specific for a second independent epitope on NT-proBNP, to form a particle/NT-proBNP/conjugate sandwich. Unbound conjugate is removed by magnetic separation and washing. After separation and washing, the particle/NT-proBNP/coniugate sandwich is transferred to the cuvette where the sandwich-bound ALP triggers an amplification cascade. ALP dephosphorylates synthetic flavin adenine dinucleotide phosphate (FADP) to produce FAD. FAD binds to apo D-amino acid oxidase and converts it to active holo D-amino acid oxidase. Each molecule of holo D-amino acid oxidase produces multiple molecules of hydrogen peroxide (H2O2). H2O2 in the presence of horseradish peroxidase (HRP), converts 3,5-dichloro-2-hydroxybenzenesulfonic acid (DCHBS) and 4-aminoantipyrine (4-AAP) to a colored product that absorbs at 510 nm. The color change measured is directly proportional to the concentration of proBNP present in the patient sample.

The Dade Behring PBNP Calibrator is a frozen liquid product containing synthetic human NT-proBNP in a bovine albumin matrix with stabilizers and preservative. The kit consists of ten vials, two vials at each of five levels, 1.0 mL in each vial.

Here's a breakdown of the acceptance criteria and study information for the Dade Behring Dimension® NT-proBNP (PBNP) Flex® reagent cartridge method, based on the provided text:

Acceptance Criteria and Device Performance

The provided text focuses on demonstrating substantial equivalence to a predicate device (Roche Diagnostics Elecsys® proBNP immunoassay) rather than explicitly stating pre-defined "acceptance criteria" for novel device performance. The performance metrics presented are comparative against the predicate.

Table of Acceptance Criteria and Reported Device Performance

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