OSX · Galectin-3 In Vitro Diagnostic Assay
Clinical Chemistry · 21 CFR 862.1117 · Class 2
Overview
| Product Code | OSX |
|---|---|
| Device Name | Galectin-3 In Vitro Diagnostic Assay |
| Regulation | 21 CFR 862.1117 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.
Classification Rationale
Class II (special controls). The special control is “Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers.”
Special Controls
*Classification.* Class II (special controls). The special control is “Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers.”
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K140436 | ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS | Fujirebio Diagnostics,Inc. | Dec 23, 2014 | SESE |
| K093758 | BGM GALECTIN -3 | Bg Medicine, Inc. | Nov 17, 2010 | SESE |
Top Applicants
- Bg Medicine, Inc. — 1 clearance
- Fujirebio Diagnostics,Inc. — 1 clearance
