(61 days)
The Stratus® CS Acute Care™ NT-proBNP method (pBNP) is an in vitro diagnostic assay for the quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP) in buman plasma. 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 NT-proBNP Calibrator (pBNP CalPak) is an in vitro diagnostic product intended to be used for calibration of the NT-proBNP method on the Stratus® CS analyzer.
The NT-proBNP Dilution Pak (DilPak) is an in vitro diagnostic product intended to be used for dilution of the NT-proBNP Method on the Stratus® CS analyzer.
The Stratus® CS Acute Care™ NT-proBNP method is a two-site sandwich assay based upon solid phase Radial Partition Immunoassav (RPIA) technology. In this procedure, dendrimer linked polyclonal antibody is added to the center portion of a square piece of glass fiber paper in the pBNP TestPak. This antibody recognizes a distinct antigenic site on the NT-proBNP molecule. Sample is then added onto the paper where it reacts with the immobilized antibody. After a short incubation, a conjugate consisting of enzyme-labeled polvclonal antibody directed against a second distinct antigenic site on the NT-proBNP molecule is pipetted onto the reaction zone of the paper. During this second incubation period, enzyme-labeled antibody reacts with the bound NT-proBNP , forming an antibody-antigen-labeled antibody sandwich. The unbound labeled antibody is later eluted from the field of view of the Stratus® CS analyzer by applying a substrate wash solution to the center of the reaction zone. By including substrate for the enzyme within the wash solution, initiation of enzyme activity occurs simultaneously with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of NT-proBNP in the sample. The reaction rate can then be measured by an optical system that monitors the reaction rate via front surface fluorescence. All data analysis functions are performed by the microprocessor within the analyzer.
Here's a summary of the acceptance criteria and study details for the Dade Behring Stratus® CS Acute Care™ NT-proBNP TestPak assay, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance was deemed "substantially equivalent" to the predicate device (Roche Diagnostics Elecsys® proBNP immunoassay). The acceptance criteria are implicitly defined by demonstrating comparable performance across various analytical and clinical metrics.
| Feature / Acceptance Criteria (Implicit) | Reported Device Performance (Stratus® CS Acute Care™ pBNP) | Comparison to Predicate (Roche Elecsys® proBNP) |
|---|---|---|
| Intended Use | For the in vitro quantitative determination of N-terminal pro-brain natriuretic peptide in human plasma as an aid in the diagnosis and assessment of severity of individuals suspected of having congestive heart failure. The test is further indicated for the risk stratification of patients with acute coronary syndrome and heart failure. | Similar intended use, with slight wording differences. The key clinical applications of diagnosis, severity assessment, and risk stratification are consistent. |
| Reportable Range | 15- 20,000 pg/mL | Predicate: 5 - 35,000 pg/mL. The Stratus® CS range is slightly narrower, but still overlaps significantly for clinical utility. |
| Analytical Sensitivity | 15 pg/mL | Predicate: 5 pg/mL. Stratus® CS has a slightly higher lower detection limit, but still within a clinically relevant range. |
| Functional Sensitivity |
§ 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.”