DEN190034 is an FDA 510(k) submission for the Control-IQ Technology. This device is classified as a Interoperable Automated Glycemic Controller (Class II - Special Controls, product code QJI).
Submitted by Tandem Diabetes Care, Inc. (San Diego, US). The FDA issued a Not Cleared (DENG) decision on December 13, 2019.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1356. An Interoperable Automated Glycemic Controller Is A Device Intended To Automatically Calculate Drug Doses Based On Inputs Such As Glucose And Other Relevant Physiological Parameters, And To Command The Delivery Of Such Drug Doses From A Connected Infusion Pump. Interoperable Automated Glycemic Controllers Are Designed To Reliably And Securely Communicate With Digitally Connected Devices To Allow Drug Delivery Commands To Be Sent, Received, Executed, And Confirmed. Interoperable Automated Glycemic Controllers Are Intended To Be Used In Conjunction With Digitally Connected Devices For The Purpose Of Maintaining Glycemic Control..
| 510(k) Number | DEN190034 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | July 15, 2019 |
| Decision Date | December 13, 2019 |
| Days to Decision | 151 days |
| Submission Type | Direct |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | QJI — Interoperable Automated Glycemic Controller |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1356 |
| Definition | An Interoperable Automated Glycemic Controller Is A Device Intended To Automatically Calculate Drug Doses Based On Inputs Such As Glucose And Other Relevant Physiological Parameters, And To Command The Delivery Of Such Drug Doses From A Connected Infusion Pump. Interoperable Automated Glycemic Controllers Are Designed To Reliably And Securely Communicate With Digitally Connected Devices To Allow Drug Delivery Commands To Be Sent, Received, Executed, And Confirmed. Interoperable Automated Glycemic Controllers Are Intended To Be Used In Conjunction With Digitally Connected Devices For The Purpose Of Maintaining Glycemic Control. |