DeviceClearance

Product code OSX— Clinical Chemistry

ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS

Classification name
Galectin-3 In Vitro Diagnostic Assay
Device class
Class 2
Regulation
21 CFR 862.1117
Advisory panel
Clinical Chemistry
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code OSX under 21 CFR 862.1117, via openFDA

Market context for product code OSX

FDA has cleared 2 devices under product code OSX between 2010 and 2014, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OSX

Recent clearances under product code OSX

Data sourced from openFDA. This site is unofficial and independent of the FDA.