K193483 is an FDA 510(k) clearance for the Basal-IQ Technology. This device is classified as a Interoperable Automated Glycemic Controller, Insulin Suspend (Class II - Special Controls, product code QJS).
Submitted by Tandem Diabetes Care, Inc. (San Diego, US). The FDA issued a Cleared decision on February 28, 2020, 73 days after receiving the submission on December 17, 2019.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1356. 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..
| 510(k) Number | K193483 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2019 |
| Decision Date | February 28, 2020 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | QJS — Interoperable Automated Glycemic Controller, Insulin Suspend |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1356 |
| 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. |