FDA Product Code NBW: System, Test, Blood Glucose, Over The Counter
FDA product code NBW covers over-the-counter blood glucose test systems for home use by people with diabetes.
These systems — comprising a meter and test strips — allow patients to measure their blood glucose level from a small fingertip blood sample in seconds. Results guide insulin dosing decisions, dietary choices, and the management of hypoglycemic and hyperglycemic episodes.
NBW devices are Class II medical devices, regulated under 21 CFR 862.1345 and reviewed by the FDA Chemistry panel.
Leading manufacturers include Apex BioTechnology Corp., I-Sens, Inc. and Bionime Corporation.
FDA 510(k) Cleared System, Test, Blood Glucose, Over The Counter Devices (Product Code NBW)
About Product Code NBW - Regulatory Context
510(k) Submission Activity
508 total 510(k) submissions under product code NBW since 2001, with 508 receiving FDA clearance (average review time: 195 days).
Submission volume has declined in recent years - 7 submissions in the last 24 months compared to 15 in the prior period.
FDA Review Time
Recent submissions under NBW have taken an average of 244 days to reach a decision - up from 194 days historically. Manufacturers should account for longer review timelines in current project planning.
NBW devices are reviewed by the Chemistry panel. Browse all Chemistry devices →