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510(k) Data Aggregation
(81 days)
The Dimension® PBNP Flex® 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 and assessment of severity of individuals suspected of having congestive heart failure and for risk stratification of patients with acute coronary syndrome and heart failure.
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 epitopes 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/conjugate 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.
Acceptance Criteria and Device Performance Study for Dade Behring Dimension® NT-proBNP (PBNP) Flex® reagent cartridge method
This document summarizes the acceptance criteria and the study demonstrating the Dade Behring Dimension® NT-proBNP (PBNP) Flex® reagent cartridge method meets these criteria, based on the provided FDA 510(k) summary. The device's performance is demonstrated through a comparison to a legally marketed predicate device, the Roche Diagnostics Elecsys® proBNP immunoassay, to establish substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Dade Behring Dimension® PBNP Flex® method are implicitly defined by demonstrating substantial equivalence to the predicate device, the Roche Diagnostics Elecsys® proBNP immunoassay, across various performance characteristics. The reported device performance is directly compared to the predicate's performance.
| Feature | Acceptance Criteria (Predicate Device Performance - Roche Elecsys® proBNP) | Reported Device Performance (Dade Behring Dimension® PBNP) |
|---|---|---|
| Intended Use | Quantitative determination of NT-proBNP in human serum and plasma as an aid in diagnosis of suspected CHF and risk stratification of ACS and CHF patients. | Quantitative determination of NT-proBNP in human plasma as an aid in diagnosis and severity assessment of suspected CHF and for risk stratification of ACS and CHF patients. |
| Assay Type (detection) | immunoassay (electrochemiluminescent) | immunoassay (photometric) |
| Reportable Range | 5 - 35,000 pg/mL | 5 - 30,000 pg/mL |
| Antibody | polyclonal (sheep) antibody | Roche Diagnostics' polyclonal (sheep) antibody |
| Cut-off | 125 pg/mL for |
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