510(k) · Cleared
Recalled · Class III · 2016Vidas NT-Probnp Assay, Model: 30 449
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
bioMerieux, Inc. · NBC Test, Natriuretic Peptide
Cleared on Feb 29, 2008 as substantially equivalent to K022516 (Roche Diagnostics Corp., 2002) after a 120-day review. Its family tree reaches back 2 generations to 2000. It has been recalled once.
- Decided
- Feb 29, 2008
- Review
- 120 days
- Class
- Class II
- Product code
- NBC
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN000010 (2000). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NBC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NBC device
- #1 K262109 Access NT-proBNPscore 13.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022516 | Elecsys Probnp ImmunoassaySummary page 2…roBNP] [ElecsyS proBNP] General Comparison Intended Use Quantitative determination of N terminal Same as initial claim [K022516]. fragment of B-type natriuretic peptide in human serum or plasma (lith… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 15, 2016 | Class III | Z-2779-2016 | Packaging | Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- None of the 2 ancestors has a recall.
- 8 other devices also cite its predicate K022516.
How does its category compare?
All NBC devicesNBC Test, Natriuretic Peptide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NBC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NBC
126in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NBC
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NBC
17in 2025
MAUDE reports naming product code NBC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 17 |
| 2008 | 7 | 126 | 0 | 15 |
| 2009 | 0 | — | 0 | 35 |
| 2010 | 1 | — | 1 | 61 |
| 2011 | 0 | — | 0 | 53 |
| 2012 | 0 | — | 2 | 23 |
| 2013 | 0 | — | 0 | 13 |
| 2014 | 0 | — | 1 | 70 |
| 2015 | 0 | — | 1 | 43 |
| 2016 | 0 | — | 0 | 31 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 0 | — | 1 | 7 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 1 | — | 1 | 6 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 26 |
| 2024 | 1 | — | 0 | 14 |
| 2025 | 1 | — | 0 | 17 |
| 2026 | 4 | 94 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073091 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073091: Vidas NT-Probnp Assay, Model: 30 449.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073091
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026