Product code QJS— Clinical Chemistry
Basal-IQ Technology
- Classification name
- Interoperable Automated Glycemic Controller, Insulin Suspend
- Device class
- Class 2
- Regulation
- 21 CFR 862.1356
- Advisory panel
- Clinical Chemistry
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code QJS
FDA has cleared device under product code QJS, all in 2020, filed by 1 applicant company. 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.
Top applicants under product code QJS
Recent clearances under product code QJS
Data sourced from openFDA. This site is unofficial and independent of the FDA.