510(k) Report

510(k) · Cleared

Cleared

BGM Galectin -3

K093758510(k) TraditionalCleared Nov 17, 2010345-day reviewClass II21 CFR 862.1117

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bg Medicine, Inc. · OSX Galectin-3 In Vitro Diagnostic Assay

Cleared on Nov 17, 2010 as substantially equivalent to K080269 (Biosite Incorporated, 2008) and 8 other predicates after a 345-day review. Its family tree reaches back 5 generations to 2000. 2 of the 15 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.

Decided
Nov 17, 2010
Review
345 days
Class
Class II
Product code
OSX
Recalls
None
Predicates
9

Its longest line of descent runs back 5 generations to DEN000010 (2000). 12 ancestors in all, the oldest K973126 (1997). 2 later devices descend from it, 2 citing it directly. 2 of the 15 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor, 1 with a Class I recall12004: 1 other ancestor2003: 2 other ancestors, 1 with a Class I recall12002: 1 other ancestor2001: 1 other ancestor1997: 1 other ancestor2014: 1 descendant cleared2011: 1 descendant clearedDEN000010 · Triage B-Type Natriuretic Peptide (BNP) Test · Biosite Incorporated · 2000K022516 · Elecsys Probnp Immunoassay · Roche Diagnostics Corp. · 2002K032646 · Elecsys Probnp Immunoassay · Roche Diagnostics Corp. · 2003K051787 · Triage BNP Test, Model 98000XR · Biosite Incorporated · 2005K052789 · Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200 · Biosite Incorporated · 2006 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors, 2 with a Class I recall22 generations back: 1 other ancestor 1 generation forward: 2 descendants K052789 · Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200 · Biosite Incorporated · 2006 · recalledK051787 · Triage BNP Test, Model 98000XR · Biosite Incorporated · 2005K032646 · Elecsys Probnp Immunoassay · Roche Diagnostics Corp. · 2003K022516 · Elecsys Probnp Immunoassay · Roche Diagnostics Corp. · 2002DEN000010 · Triage B-Type Natriuretic Peptide (BNP) Test · Biosite Incorporated · 2000−50
  1. Root · 5 generations backDEN000010 Triage B-Type Natriuretic Peptide (BNP) TestBiosite Incorporated · 2000
  2. 4 generations backK022516 Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2002
  3. 3 generations backK032646 Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2003
  4. 2 generations backK051787 Triage BNP Test, Model 98000XRBiosite Incorporated · 2005
  5. 1 generation backK052789 Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200Biosite Incorporated · 2006 · Recalled
  6. This deviceK093758 BGM Galectin -3Bg Medicine, Inc. · 2010
  7. Descendant · cites it directly · 0 of its ownK140436 ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS…Fujirebio Diagnostics,Inc. · 2014
  8. Descendant · cites it directly · 0 of its ownK111452 Presage ST2 AssayCritical Care Diagnostics, Inc. (Dba Critical Diag · 2011 · Recalled

Class I recalls in this family

  • K080269 Triage Cardioprofiler and Profiler S.O.B. Panelsdirect predicate · 2008
  • K030286 Triage Cardio Profiler/Triage Cardiac Paneldirect predicate · 2003

Most influential descendants

Showing 2 of 2 · See all
  • K140436ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3…Fujirebio Diagnostics,Inc. · 2014 · cites it directly0descendants
  • K111452Presage ST2 AssayCritical Care Diagnostics, Inc. (Dba Critical Diag · 2011 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5DEN000010Triage B-Type Natriuretic Peptide (BNP) TestBiosite Incorporated2000—
−4K022516Elecsys Probnp ImmunoassayRoche Diagnostics Corp.2002—
−3K032646Elecsys Probnp ImmunoassayRoche Diagnostics Corp.2003—
−2K051787Triage BNP Test, Model 98000XRBiosite Incorporated2005—
−1K052789Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200Biosite Incorporated20061
0 (this device)K093758BGM Galectin -3Bg Medicine, Inc.2010—
+1K140436ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT…Fujirebio Diagnostics,Inc.2014—
+1K111452Presage ST2 AssayCritical Care Diagnostics, Inc. (Dba Critical Diag20111

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200110
200210
200321
200410
200811

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201410
FIG. 1 — Lineage of K093758, 2000–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (9)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K080269Triage Cardioprofiler and Profiler S.O.B. Panels
Summary page 1
…say Classification name: Galectin-3 IVD assay Product Code: OSX Predicate Device Biosite, Inc. Triagee B-Type Natriuretic Peptide (BNP) Test (K080269, K052789, K051787, K033383, K032235, K030286, K021317, K010266, and K003475). Device Description BGM Galectin-3 is a microtiter…
Biosite Incorporated2008Class I
*K052789Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200
Summary page 1
…ification name: Galectin-3 IVD assay Product Code: OSX Predicate Device Biosite, Inc. Triagee B-Type Natriuretic Peptide (BNP) Test (K080269, K052789, K051787, K033383, K032235, K030286, K021317, K010266, and K003475). Device Description BGM Galectin-3 is a microtiter plate-bas…
Biosite Incorporated20061
*K051787Triage BNP Test, Model 98000XR
Summary page 1
…name: Galectin-3 IVD assay Product Code: OSX Predicate Device Biosite, Inc. Triagee B-Type Natriuretic Peptide (BNP) Test (K080269, K052789, K051787, K033383, K032235, K030286, K021317, K010266, and K003475). Device Description BGM Galectin-3 is a microtiter plate-based sandwi…
Biosite Incorporated2005—
*K033383Triage BNP Test for the Beckman Coulter Immunoassay Systems, Model Catalog #98200
Summary page 1
…Galectin-3 IVD assay Product Code: OSX Predicate Device Biosite, Inc. Triagee B-Type Natriuretic Peptide (BNP) Test (K080269, K052789, K051787, K033383, K032235, K030286, K021317, K010266, and K003475). Device Description BGM Galectin-3 is a microtiter plate-based sandwich enzyme…
Biosite Incorporated20031
*K032235Modification to Triage B-Type Natriuretic Peptide (BNP) Test
Summary page 1
…alectin-3 IVD assay Product Code: OSX Predicate Device Biosite, Inc. Triagee B-Type Natriuretic Peptide (BNP) Test (K080269, K052789, K051787, K033383, K032235, K030286, K021317, K010266, and K003475). Device Description BGM Galectin-3 is a microtiter plate-based sandwich enzyme-linked i…
Biosite Incorporated2004—
*K030286Triage Cardio Profiler/Triage Cardiac Panel
Summary page 1
…IVD assay Product Code: OSX Predicate Device Biosite, Inc. Triagee B-Type Natriuretic Peptide (BNP) Test (K080269, K052789, K051787, K033383, K032235, K030286, K021317, K010266, and K003475). Device Description BGM Galectin-3 is a microtiter plate-based sandwich enzyme-linked immunosorb…
Biosite Incorporated2003Class I
*K021317Triage B-Type Natriuretic Peptide (BNP) Test
Summary page 1
…y Product Code: OSX Predicate Device Biosite, Inc. Triagee B-Type Natriuretic Peptide (BNP) Test (K080269, K052789, K051787, K033383, K032235, K030286, K021317, K010266, and K003475). Device Description BGM Galectin-3 is a microtiter plate-based sandwich enzyme-linked immunosorbant assay…
Biosite Incorporated2002—
*K010266Triage B-Type Natriuretic Peptide (BNP) Test, Catalog #98000
Summary page 1
…Code: OSX Predicate Device Biosite, Inc. Triagee B-Type Natriuretic Peptide (BNP) Test (K080269, K052789, K051787, K033383, K032235, K030286, K021317, K010266, and K003475). Device Description BGM Galectin-3 is a microtiter plate-based sandwich enzyme-linked immunosorbant assay (ELISA)…
Biosite Incorporated2001—
*DEN000010Triage B-Type Natriuretic Peptide (BNP) Test
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.
Biosite Incorporated2000—

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K140436ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3…Fujirebio Diagnostics,Inc.20140
K111452Presage ST2 AssayCritical Care Diagnostics, Inc. (Dba Critical Diag20110

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K080269Triage Cardioprofiler and Profiler S.O.B. PanelsBiosite Incorporated · 2008 · Direct predicate · ◆ in the 2008 ancestors bar of FIG. 12 Class I recalls
  • K030286Triage Cardio Profiler/Triage Cardiac PanelBiosite Incorporated · 2003 · Direct predicate · ◆ in the 2003 ancestors bar of FIG. 12 Class I recalls

What does this lineage say?

  • The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
  • 4 of the 12 ancestors have a recall of any class; 2 have a Class I recall.
  • Of its descendants, K140436 (Fujirebio Diagnostics,Inc., 2014) has gone furthest, with 0 descendants of its own.

How does its category compare?

All OSX devices

OSX Galectin-3 In Vitro Diagnostic Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · OSX

1in 2014

2010: 12014: 1
2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OSX

Too few OSX 510(k)s in any year since 2007 to give a median.

Recalls per year · OSX

No recall names OSX since 2007.

Adverse event reports per year · OSX

No MAUDE report names OSX since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20101—00
20110—00
20120—00
20130—00
20141—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

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).

Indications for use as stated in the FDA summary.

Recent decisions in OSX

The OSX category page

  • K140436ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLSFujirebio Diagnostics,Inc. · 2014

https://510kreport.com/device/K093758 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093758: BGM Galectin -3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093758

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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