Product Classification

• Device: galectin-3 in vitro diagnostic assay
• Regulation Description: B-type natriuretic peptide test system.
• 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.
• Physical State: in vitro diagnostic reagent kit
• Technical Method: enzyme linked immunosorbent assay (ELISA)
• Target Area: in vitro diagnostic for use with serum and plasma
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Product Code: OSX
• Premarket Review: Division of Chemistry and Toxicology Devices (DCTD); Division of Chemistry and Toxicology Devices (DCTD)
• Submission Type: 510(k)
• Regulation Number: 862.1117
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible