510(k) · Cleared
ClearedST Aia-Pack BNP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujirebio Diagnostics,Inc. · NBC Test, Natriuretic Peptide
Cleared on Aug 24, 2020 as substantially equivalent to K031038 (Bayer Healthcare, LLC, 2003) after a 360-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Aug 24, 2020
- Review
- 360 days
- Class
- Class II
- Product code
- NBC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010266 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK010266 Triage B-Type Natriuretic Peptide (BNP) Test, Catalog #98000Biosite Incorporated · 2001
- 1 generation backK031038 Advia Centaur B-Type Natriuretic Peptide (BNP) AssayBayer Healthcare, LLC · 2003 · Recalled
- This deviceK192380 ST Aia-Pack BNPFujirebio Diagnostics,Inc. · 2020
- Descendant · cites it directly · 0 of its ownK211199 ST AIA-PACK BNP AssayTosoh Bioscience, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K211199ST AIA-PACK BNP AssayTosoh Bioscience, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010266 | Triage B-Type Natriuretic Peptide (BNP) Test, Catalog #98000 | Biosite Incorporated | 2001 | — |
| −1 | K031038 | Advia Centaur B-Type Natriuretic Peptide (BNP) Assay | Bayer Healthcare, LLC | 2003 | 6 |
| 0 (this device) | K192380 | ST Aia-Pack BNP | Fujirebio Diagnostics,Inc. | 2020 | — |
| +1 | K211199 | ST AIA-PACK BNP Assay | Tosoh Bioscience, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
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 |
|---|---|---|---|
| * | K031038 | Advia Centaur B-Type Natriuretic Peptide (BNP) AssaySummary page 6…te Tips (96 Tips x 5 Racks) K. Substantial Equivalence Information: 1. Predicate device name(s): SIEMENS ADVIA Centaur® BNP Assay 2. Predicate 510(k) number(s): K031038 3. Comparison with predicate: Similarities SIEMENS ADVIA C… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211199 | ST AIA-PACK BNP Assay | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 17.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K211199 (Tosoh Bioscience, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K031038.
How does its category compare?
All NBC devicesNBC Test, Natriuretic Peptide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The Tosoh ST AIA-PACK BNP assay is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative
measurement of BNP in human K2EDTA plasma on Tosoh AIA System analyzers. BNP is used as an aid in the diagnosis
of heart failure (HF) in patients presenting to the emergency department (ED) with clinical suspicion of new onset HF,
acutely decompensated or exacerbated HF.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192380 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192380: ST Aia-Pack BNP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192380
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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