510(k) · Cleared
ClearedST AIA-PACK BNP Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tosoh Bioscience, Inc. · NBC Test, Natriuretic Peptide
Cleared on Nov 8, 2021 as substantially equivalent to K192380 (Fujirebio Diagnostics,Inc., 2020) after a 200-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Nov 8, 2021
- Review
- 200 days
- Class
- Class II
- Product code
- NBC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010266 (2001). No later device cites it as a predicate yet.
- Root · 3 generations backK010266 Triage B-Type Natriuretic Peptide (BNP) Test, Catalog #98000Biosite Incorporated · 2001
- 2 generations backK031038 Advia Centaur B-Type Natriuretic Peptide (BNP) AssayBayer Healthcare, LLC · 2003 · Recalled
- 1 generation backK192380 ST Aia-Pack BNPFujirebio Diagnostics,Inc. · 2020
- This deviceK211199 ST AIA-PACK BNP AssayTosoh Bioscience, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010266 | Triage B-Type Natriuretic Peptide (BNP) Test, Catalog #98000 | Biosite Incorporated | 2001 | — |
| −2 | K031038 | Advia Centaur B-Type Natriuretic Peptide (BNP) Assay | Bayer Healthcare, LLC | 2003 | 6 |
| −1 | K192380 | ST Aia-Pack BNP | Fujirebio Diagnostics,Inc. | 2020 | — |
| 0 (this device) | K211199 | ST AIA-PACK BNP Assay | Tosoh Bioscience, Inc. | 2021 | — |
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 |
|---|---|---|---|
| * | K192380 | ST Aia-Pack BNPSummary page 5…r: Page 2 of 7 Section 5 - 510(k) Summary or 510(k) Statement k192380 5. DEVICE DESCRIPTION The ST AIA-PACK BNP is a two-site immunoenzymometric assay which is performed entirely in the ST A… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All NBC devicesNBC Test, Natriuretic Peptide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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/K211199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211199: ST AIA-PACK BNP Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211199
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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