# K140436: ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: Dec 23, 2014 after 305 days
- Product code: OSX (Galectin-3 In Vitro Diagnostic Assay)
- 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: 6 generations back to DEN000010 (2000). 13 ancestors in all.
No later device cites it as a predicate yet.
2 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093758: BGM Galectin -3, Bg Medicine, Inc. (2010) Summary page 7.

## Indications for use
Reagent Kit: The ARCHITECT Galectin-3 assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of galectin-3 in human serum and EDTA plasma. The ARCHITECT Galectin-3 assay may be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure (HF). The ARCHITECT Galectin-3 assay is used with the ARCHITECT i System with STAT protocol capability. Calibrators: The ARCHITECT Galectin-3 Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of galectin-3 in human serum and EDTA plasma. Controls: The ARCHITECT Galectin-3 Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of galectin-3 in human serum and EDTA plasma.

Source page: https://510kreport.com/device/K140436
Methodology: https://510kreport.com/methodology