(120 days)
VIDAS® NT-proBNP assay is an automated quantitative test for use on the VIDAS instruments for the determination of N terminal fragment of B-type natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA (Enzyme-Linked Fluorescent Assay) technique. The VIDAS NT-proBNP test is used as an aid in the diagnosis of suspected congestive heart failure.
The VIDAS® NT-proBNP assay is an automated quantitative test for use on the VIDAS instruments for the determination of N terminal fragment of B-type natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA (Enzyme-Linked Fluorescent Assay) technique. The VIDAS NT-proBNP test is used as an aid in the diagnosis of suspected congestive heart failure.
The assay principle combines a one-step immunoassay sandwich method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR), a pipette tip-like device, serves as the solid phase as well as the pipetting device for the assay. The assay reagents are ready-to-use and pre-dispensed in the sealed reagent strips (STRs). The individual kit components are described in detail in the 510(k) and in the package insert.
All of the assay steps are performed automatically by the VIDAS instrument. The sample is transferred into the well containing anti-NT-proBNP antibody (conjugate) labeled with alkaline phosphatase. The sample/conjugate mixture is cycled in and out of the SPR several times. This operation enables the antigen to bind with the immunoglobulins fixed to the interior wall of the SPR and the conjugate to form a sandwich. Unbound compounds are eliminated during washing steps.
Two detection steps are performed successively. During each step, the substrate (4-Methylumbelliferyl phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methyl-umbelliferone) the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is proportional to the concentration of antigen present in the sample.
At the end of the assay, results are automatically calculated by the VIDAS instrument in relation to two calibration curves corresponding to the two detection steps stored in memory, and then printed out.
Here's a breakdown of the acceptance criteria and study details for the VIDAS® NT-proBNP Assay, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Device Performance
The acceptance criteria are not explicitly stated as pass/fail thresholds in the document, but rather demonstrated through comparison to the predicate device and established analytical/clinical performance figures. The reported device performance is directly from the provided text.
| Criteria Category | Specific Criterion | Predicate Device Performance [Elecsys proBNP] | VIDAS® NT-proBNP Assay Performance |
|---|---|---|---|
| Analytical Performance | |||
| Precision | Repeatability (intra-run) | 1.8 – 2.7%CV | 1.5 – 2.8 %CV |
| Inter-site precision | Not explicitly stated, total precision: 2.2 – 3.2%CV | 3.4 – 5.1 %CV | |
| Inter-lot precision | Not explicitly stated | 3.5 – 8.4 %CV | |
| Detection Limits | Lower Limit of Detection (LoD) | 5 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.”