Sensor, Glucose, Invasive
The invasive glucose sensor is a clinical chemistry device used in adults with diabetes to continuously monitor interstitial glucose levels, detecting trends and tracking glycemic patterns as an adjunct to standard home blood glucose monitoring rather than as a replacement. It is classified as FDA Class III, requiring Premarket Approval (PMA) with clinical evidence of safety and effectiveness, reflecting the high risk associated with invasive continuous monitoring. The product code is MDS and no regulation number has been assigned. The device is not implanted long-term and does not sustain life.
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Basic Information
- Product Code
- MDS
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- CH
- Submission Type
- 2
Device Characteristics
Definition
The device is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes. The device is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The system aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.
FEI Numbers
This FDA classification entry is associated with 20 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 20 registration numbers. Click on an entry to view related FDA registrations.