510(k) · Cleared
Recalled · Class III · 2019Architect BNP Assay, Model 8K28
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 May 25, 2006 as substantially equivalent to K033606 (Axis-Shield Diagnostics, Ltd., 2004) after a 48-day review. Its family tree reaches back 2 generations to 2002. It has been recalled 2 times.
- Decided
- May 25, 2006
- Review
- 48 days
- Class
- Class II
- Product code
- NBC
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K021317 (2002). No later device cites it as a predicate yet.
- Root · 2 generations backK021317 Triage B-Type Natriuretic Peptide (BNP) TestBiosite Incorporated · 2002
- 1 generation backK033606 Abbott Axsym B-Type Natriuretic Peptide (BNP) Microparticle Enzyme…Axis-Shield Diagnostics, Ltd. · 2004
- This deviceK060964 Architect BNP Assay, Model 8K28Fujirebio Diagnostics,Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021317 | Triage B-Type Natriuretic Peptide (BNP) Test | Biosite Incorporated | 2002 | — |
| −1 | K033606 | Abbott Axsym B-Type Natriuretic Peptide (BNP) Microparticle Enzyme Immunoassay… | Axis-Shield Diagnostics, Ltd. | 2004 | — |
| 0 (this device) | K060964 | Architect BNP Assay, Model 8K28 | Fujirebio Diagnostics,Inc. | 2006 | — |
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 13.9 · 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 |
|---|---|---|---|
| * | K033606 | Abbott Axsym B-Type Natriuretic Peptide (BNP) Microparticle Enzyme Immunoassay (Meia) TestSummary page 4…(Proposed Device) (Predicate Device) K033606 Device Type In vitro diagnostic In vitro diagnostic Classification and Class II, NBC… | 2004 |
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 |
|---|---|---|---|---|
| May 24, 2019 | Class III | Z-2079-2019 | Under Investigation by firm | Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing. |
| May 24, 2019 | Class III | Z-2078-2019 | Under Investigation by firm | Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All NBC devicesNBC Test, Natriuretic Peptide: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 ARCHITECT BNP assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma on the ARCHITECT i System. BNP values are used as an aid in the diagnosis and assessment of severity of heart failure. The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of human B-type natriuretic peptide…
Read the full statement (149 words)
The ARCHITECT BNP assay is a chemiluminescent microparticle immunoassay
(CMIA) for the quantitative determination of human B-type natriuretic peptide (BNP) in
human EDTA plasma on the ARCHITECT i System. BNP values are used as an aid in
the diagnosis and assessment of severity of heart failure.
The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT i System
when used for the quantitative determination of human B-type natriuretic peptide (BNP)
in human EDTA plasma. Refer to the ARCHITECT BNP reagent package insert and
ARCHITECT i System for additional information.
The ARCHITECT BNP Controls are for the estimation of test precision and the
detection of systematic analytical deviations of the ARCHITECT i System (reagents,
calibrators, and instrument), when used for the quantitative determination of human B-
type natriuretic peptide (BNP) in human EDTA plasma. Refer to the ARCHITECT BNP
reagent package insert and ARCHITECT i System for additional information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060964 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060964: Architect BNP Assay, Model 8K28.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060964
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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