# K060964: Architect BNP Assay, Model 8K28

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: May 25, 2006 after 48 days
- Product code: NBC (Test, Natriuretic Peptide)
- Device class: 2
- Regulation: 21 CFR 862.1117
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K021317 (2002). 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)
- K033606: Abbott Axsym B-Type Natriuretic Peptide (BNP) Microparticle Enzyme Immunoassay (Meia) Test, Axis-Shield Diagnostics, Ltd. (2004) Summary page 4.

## Recalls of this device
- May 24, 2019 · Class III · Z-2079-2019: 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: Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.

## Indications for use
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.

Source page: https://510kreport.com/device/K060964
Methodology: https://510kreport.com/methodology