(80 days)
The PBNP method is an in vitro diagnostic assay for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human serum and plasma on the Dimension Vista™ System. 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 Dimension Vista™ NT-proBNP (PBNP) calibrator is an in vitro diagnostic product for the calibration of the N-terminal pro-brain natriuretic peptide (PBNP) method on the Dimension Vista™ System.
The PBNP method is a one-step sandwich chemiluminescent immunoassay based on Luminescent Oxygen Channeling Immunoassay (LOCI™) technology. LOCI™ reagents include two latex bead reagents and a biotinylated polyclonal antibody fragment which recognize an epitope located in the N-terminal part of proBNP. The first bead reagent (Sensibeads) is coated with streptavidin and contains photosensitive dye. The second bead reagent (Chemibeads) is coated with a second antibody specific for a second independent epitope on NT-proBNP and contains chemiluminescent dye. Sample is incubated with Chemibeads and biotinylated antibody to form a particle/NTproBNP/biotinylated antibody sandwich. Sensibeads then are added and bind to form a bead-aggregated immunocomplex. Illumination of the complex by light at 680 nm generates singlet oxygen from Sensibeads, which diffuses to the Chemibeads and triggers a chemiluminescent reaction. The resulting chemiluminescent signal is measured at 612 nm and is directly proportional to the concentration of NT-proBNP in the sample.
The PBNP Calibrator is a frozen liquid product containing synthetic human N-terminal pro-brain natriuretic peptide in a bovine albumin matrix with stabilizers and preservative. The kit consists of eight vials, two each of four levels (A, B, C, and D), 1.0 mL per vial for levels A, C, and D and 1.5 mL per vial for level B.
The provided text describes a 510(k) premarket notification for a medical device, the Dimension Vista™ PBNP reagent cartridge and calibrator. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria with explicit statistical results.
Therefore, many of the requested elements (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, ground truth for training set) are not present in this type of summary document, as the focus is on comparative performance against an already approved device rather than establishing de novo performance against a predefined independent standard.
However, based on the information available, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly based on demonstrating "substantial equivalence" to the predicate device, the Roche Diagnostics Elecsys® proBNP immunoassay and proBNP CalSet Calibrator (K032646/K022516). The "reported device performance" are the features and characteristics of the new device that are compared to the predicate.
| Feature | Implicit Acceptance Criteria (similar to predicate) | Dimension Vista® PBNP (Reported Performance) | Roche Elecsys® proBNP (Predicate Performance for comparison) |
|---|---|---|---|
| Intended Use | Quantitative NT-proBNP measurement in human serum/plasma; aid in diagnosis/assessment of CHF severity; risk stratification for ACS/HF. | Quantitative NT-proBNP measurement in human serum/plasma; aid in diagnosis/assessment of CHF severity; risk stratification for ACS/HF. | Quantitative NT-proBNP measurement in human serum/plasma; aid in diagnosis of CHF; risk stratification for ACS/CHF. |
| Assay Type | Immunoassay | Immunoassay (chemiluminescent) | Immunoassay (electrochemiluminescent) |
| Reportable Range | 5 - 35,000 pg/mL | 5 - 35,000 pg/mL | 5 - 35,000 pg/mL |
| Antibody | Polyclonal (sheep) antibody | Roche Diagnostics' polyclonal (sheep) antibody | Polyclonal (sheep) antibody |
| Cut-off | 125 pg/mL ( |
§ 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.”