K202145 is an FDA 510(k) clearance for the Bigfoot Unity Diabetes Management System. This device is classified as a Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems (Class II - Special Controls, product code QLG).
Submitted by Bigfoot Biomedical, Inc. (Milpitas, US). The FDA issued a Cleared decision on May 7, 2021, 280 days after receiving the submission on July 31, 2020.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1355. An Integrated Continuous Glucose Monitoring System For Replacement Of Finger Stick Blood Glucose Testing For Diabetes Treatment Decisions In Persons With Diabetes, Unless Otherwise Indicated. The System Automatically Measures Glucose In Bodily Fluids Continuously Or Frequently For A Specified Period Of Time. The System Is Also Designed To Reliably And Securely Transmit Glucose Measurement Data To Digitally Connected Devices And Are Intended To Be Used Alone Or In Conjunction With These Digitally Connected Devices Where The User Manually Controls Actions For Therapy Decisions. The System Is Not Intended To Be Used With Automated Insulin Dosing (aid) Systems..
| 510(k) Number | K202145 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2020 |
| Decision Date | May 07, 2021 |
| Days to Decision | 280 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | QLG - Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1355 |
| Definition | An Integrated Continuous Glucose Monitoring System For Replacement Of Finger Stick Blood Glucose Testing For Diabetes Treatment Decisions In Persons With Diabetes, Unless Otherwise Indicated. The System Automatically Measures Glucose In Bodily Fluids Continuously Or Frequently For A Specified Period Of Time. The System Is Also Designed To Reliably And Securely Transmit Glucose Measurement Data To Digitally Connected Devices And Are Intended To Be Used Alone Or In Conjunction With These Digitally Connected Devices Where The User Manually Controls Actions For Therapy Decisions. The System Is Not Intended To Be Used With Automated Insulin Dosing (aid) Systems. |