This excerpt below is from a 510(k)Summary for Amira in a 510(k) for its diabetes related data management system:
“AtLast DMS is considered an unclassified accessory to glucose test systems; glucose test systems are ….
The device regulation for a “calculator/data processing module for clinical use” (21 CFR 862.2100) exempts such Class I devices from 510(k) requirements. This regulation is not entirely applicable, however, since the exemption only applies to data processors for clinical laboratory use, and not home use or use in clinic settings.”