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SBAClass II

Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate

21 CFR 862.1357 / Clinical Chemistry
FDA source (opens on fda.gov)

SBA is the FDA product code for Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate, a class II device type, regulated under 21 CFR 862.1357. FDA's definition for this code reads: "An integrated continuous glucose monitoring system (iCGM) with sensor containing dexamethasone acetate is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
SBA
Device name
Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate
FDA definition
An integrated continuous glucose monitoring system (iCGM) with sensor containing dexamethasone acetate is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control. The dexamethasone acetate coating is intended to reduce inflammation at the sensor insertion site.
Regulation
21 CFR 862.1357
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code SBA

By decision year
2 clearances under product code SBA with a decision year between 2024 and 2024, 2024 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code SBA by decision year
YearClearances
20242

Applicants with the most clearances

Product code SBA
Applicants holding the most 510(k) clearances under product code SBA
ApplicantClearances
Senseonics, Incorporated2

Companies listing this code with FDA

Companies whose registered establishments list this code