Galectin-3 In Vitro Diagnostic Assay
The Galectin-3 In Vitro Diagnostic Assay (product code OSX) is a clinical chemistry assay intended for use in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure. Galectin-3 is a biomarker associated with cardiac fibrosis and heart failure progression. As an FDA Class 2 device under regulation 862.1117, it requires 510(k) premarket clearance and falls within the Clinical Chemistry specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- OSX
- Device Class
- FDA class 2
- Regulation Number
- 862.1117
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K140436 | ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS | Dec 23, 2014 | Substantially Equivalent | Fujirebio Diagnostics,Inc. |
| K093758 | BGM GALECTIN -3 | Nov 17, 2010 | Substantially Equivalent | Bg Medicine, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.