# K073091: Vidas NT-Probnp Assay, Model: 30 449

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Feb 29, 2008 after 120 days
- Product code: NBC (Test, Natriuretic Peptide)
- Device class: 2
- Regulation: 21 CFR 862.1117
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN000010 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022516: Elecsys Probnp Immunoassay, Roche Diagnostics Corp. (2002) Summary page 2.

## Recalls of this device
- Apr 15, 2016 · Class III · Z-2779-2016: Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials.

## Indications for use
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.

Source page: https://510kreport.com/device/K073091
Methodology: https://510kreport.com/methodology