QJS — Interoperable Automated Glycemic Controller, Insulin Suspend Class II

FDA Device Classification

Classification Details

Product Code
QJS
Device Class
Class II
Regulation Number
862.1356
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Definition

An interoperable automated glycemic controller, insulin suspend, is a device that temporarily suspend and resumes insulin infusion from a connected infusion pump based on specified thresholds and input glucose levels. Interoperable automated glycemic controllers, insulin suspend, are designed to reliably and securely communicate with digitally connected devices to allow insulin delivery suspension and resumption commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers, insulin suspend, are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K193483tandem diabetes careBasal-IQ TechnologyFebruary 28, 2020