(160 days)
Immunoassay for the in vitro quantitative determination of N-terminal pro-brain natriuretic peptide in human serum and plasma. The Elecsys proBNP II STAT assay is used as an aid in the diagnosis of individuals suspected of having congestive heart failure. The test is further indicated for the risk stratification of patients with acute coronary syndrome and congestive heart failure. The test may also serve as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 601 immunoassay analyzer.
The proBNP II Assay is a sandwich immunoassay with two antibodies directed towards epitopes within the N-terminal portion of the proBNP molecule. The capture antibody is biotinylated to react with streptavidin-coated microparticles. The signal antibody is tagged with ruthenium. Both antibodies are monoclonal. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 601 immunoassay analyzer.
Acceptance Criteria and Device Performance Study for Elecsys proBNP II STAT Immunoassay
This document describes the acceptance criteria and the study that demonstrates the Elecsys proBNP II STAT Immunoassay meets these criteria, based on the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Elecsys proBNP II STAT Immunoassay are primarily demonstrated by showing substantial equivalence to the predicate device, the Elecsys proBNP II Assay (K072437), with key performance characteristics either matching or falling within acceptable ranges. The primary difference is the faster "STAT" application time and limited instrument platform.
| Feature | Acceptance Criteria (Predicate Device K072437) | Reported Device Performance (Elecsys proBNP II STAT Assay) |
|---|---|---|
| Intended Use/Indications for Use | Immunoassay for the in vitro quantitative determination of N-terminal pro-brain natriuretic peptide in human serum and plasma. Aid in diagnosis of individuals suspected of congestive heart failure. Risk stratification of patients with acute coronary syndrome and congestive heart failure. Aid in assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure with stable coronary artery disease. Intended for use on Elecsys and cobas e immunoassay analyzers. | Same, except: Assay name changed to "Elecsys proBNP II STAT assay". Intended for use only on the cobas e 601 immunoassay analyzer. |
| Assay Protocol | Sandwich assay | Same |
| Detection Protocol | Electrochemiluminescent Immunoassay | Same |
| Application Time | 18 Minute | STAT (9 Minute) - This is a key improvement/change. |
| Instrument Platform | Roche Elecsys 2010/cobas e 411 and MODULAR ANALYTICS E170/cobas e 601 | cobas e 601 - Limited to this specific platform. |
| Sample Volume | 15 µL | Same |
| Sample Type | Human serum and plasma treated with K2-EDTA, K3-EDTA, lithium heparin and Na-heparin plasma. | Same |
| Reagents | Sandwich immunoassay with two monoclonal antibodies (biotinylated capture (streptavidin-coated microparticles) and ruthenium-tagged signal) directed towards epitopes within the N-terminal portion of the proBNP molecule. | Same antibodies and same epitopes. |
| Traceability/Standardization | Standardized against the Elecsys proBNP assay (K022516), which was standardized against reference standards by weighing pure synthetic NT-proBNP (1-76 amino acids) into equine serum matrix. | Same. |
| Calibrator | Elecsys proBNP II CalSet (K072437) | Elecsys proBNP II STAT CalSet (different material number, identical stability, value assignment, and matrix). |
| Calibration Interval | Once per reagent lot (fresh reagent, |
§ 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.”