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Device
system, test, blood glucose, over the counter
Regulation Description
Glucose test system.
Regulation Medical Specialty
Clinical Chemistry
Review Panel
Clinical Chemistry
Product Code
NBW
Premarket Review
Division of Chemistry and Toxicology Devices
(DCTD)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type
510(k)
Regulation Number
862.1345
Device Class
2
Total Product Life Cycle (TPLC)
TPLC Product Code Report
GMP Exempt?
No
Summary Malfunction
Reporting
Ineligible
Implanted Device?
No
Life-Sustain/Support Device?
No
Recognized Consensus Standards
7-284 CLSI EP37 1st Edition
Supplemental Tables for Interference Testing in Clinical Chemistry
7-301 CLSI GP42 7th Edition
Collection of Capillary Blood Specimens
13-88 IEEE ISO 11073-10417 Third edition 2017-04
Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter
13-90 IEEE Std 11073-10417-2015
Health Informatics - Personal Health Device Communication, Part 10417: Device Specialization - Glucose Meter
Guidance Documents
Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use: Guidance for Industry and Food and Drug Administration Staff
Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use - Guidance for Industry and Food and Drug Administration Staff
Third Party Review
Not Third Party Eligible
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