# K211199: ST AIA-PACK BNP Assay

- Pathway: 510(k) (Special)
- Applicant: Tosoh Bioscience, Inc.
- Decided: Nov 8, 2021 after 200 days
- Product code: NBC (Test, Natriuretic Peptide)
- Device class: 2
- Regulation: 21 CFR 862.1117
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K010266 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192380: ST Aia-Pack BNP, Fujirebio Diagnostics,Inc. (2020) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K211199
Methodology: https://510kreport.com/methodology