# K093758: BGM Galectin -3

- Pathway: 510(k) (Traditional)
- Applicant: Bg Medicine, Inc.
- Decided: Nov 17, 2010 after 345 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: 5 generations back to DEN000010 (2000). 12 ancestors in all.
2 later devices descend from it; 2 cite it directly.
2 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080269: Triage Cardioprofiler and Profiler S.O.B. Panels, Biosite Incorporated (2008) Summary page 1.
- K052789: Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200, Biosite Incorporated (2006) Summary page 1.
- K051787: Triage BNP Test, Model 98000XR, Biosite Incorporated (2005) Summary page 1.
- K033383: Triage BNP Test for the Beckman Coulter Immunoassay Systems, Model Catalog #98200, Biosite Incorporated (2003) Summary page 1.
- K032235: Modification to Triage B-Type Natriuretic Peptide (BNP) Test, Biosite Incorporated (2004) Summary page 1.
- K030286: Triage Cardio Profiler/Triage Cardiac Panel, Biosite Incorporated (2003) Summary page 1.
- K021317: Triage B-Type Natriuretic Peptide (BNP) Test, Biosite Incorporated (2002) Summary page 1.
- K010266: Triage B-Type Natriuretic Peptide (BNP) Test, Catalog #98000, Biosite Incorporated (2001) Summary page 1.
- DEN000010: Triage B-Type Natriuretic Peptide (BNP) Test, Biosite Incorporated (2000). Our reading of the summary gave K003475, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN000010, Triage B-Type Natriuretic Peptide (BNP) Test (Biosite Incorporated), granted Nov 20, 2000; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K140436: ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS (2014), 0 descendants of its own
- K111452: Presage ST2 Assay (2011), 0 descendants of its own

## Indications for use
BGM Galectin-3 is an in vitro diagnostic device that quantitatively measures galectin-3 in serum or EDTA-plasma by enzyme linked immunosorbant assay (ELISA) on a microtiter plate platform. BGM Galectin-3 is indicated for use in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure (HF).

Source page: https://510kreport.com/device/K093758
Methodology: https://510kreport.com/methodology