FDA product code OSX: Galectin-3 In Vitro Diagnostic Assay
OSX is the FDA product code for galectin-3 in vitro diagnostic assay. It is a Class II device, regulated under 21 CFR 862.1117 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under OSX, from 2 different applicants. The average 510(k) review took 325 days (median 325).
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.
Classification
| Field | Value |
|---|---|
| Device name | Galectin-3 In Vitro Diagnostic Assay |
| Device class | Class II |
| Regulation | 21 CFR 862.1117 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every OSX clearance
Top OSX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fujirebio Diagnostics,Inc. | 1 | 2014-12-23 |
| Bg Medicine, Inc. | 1 | 2010-11-17 |
Most recent OSX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K140436 | Fujirebio Diagnostics,Inc. | ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS | 2014-12-23 | 305 |
| K093758 | Bg Medicine, Inc. | BGM GALECTIN -3 | 2010-11-17 | 345 |
Recalls for OSX devices
openFDA lists no recalls for product code OSX.
Frequently asked questions
What is FDA product code OSX?
OSX is the FDA product code for galectin-3 in vitro diagnostic assay. It is a Class II device, regulated under 21 CFR 862.1117 and reviewed by the Clinical Chemistry panel.
What device class is OSX?
Class II, regulation 21 CFR 862.1117. Typical premarket route: 510(k).
How long does a 510(k) take for product code OSX?
Across 2 cleared submissions the average was 325 days from receipt to decision (median 325).
Which companies have the most OSX clearances?
Fujirebio Diagnostics,Inc. (1); Bg Medicine, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OSX
- Run a recall and safety report across every OSX manufacturer
- Watch product code OSX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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