Chrysalis Intelligence · Product Codes · QLG

QLG · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

Clinical Chemistry · 9 clearances · 2 unique sponsors

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Device class
Class II
Regulation 862.1355
Total clearances
9
2020-06-12 → 2023-03-01
Last 12 months
0
Unique sponsors
2
Definition

What is Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

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.
Classification details
Medical specialty
Clinical Chemistry
Review panel
CH
Regulation number
862.1355
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Abbott Diabetes Care, Inc. 7 0 2023-02-21
Bigfoot Biomedical, Inc. 2 0 2023-03-01
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
95250 CPT — High Continuous glucose monitoring system insertion and monitoring; standard code for integrated CGM systems
95251 CPT — High Continuous glucose monitoring system replacement; follows initial insertion code
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2023-03-01 K222280 Bigfoot Biomedical, Inc. Bigfoot Unity® Diabetes Management System
2023-02-21 K223537 Abbott Diabetes Care, Inc. FreeStyle Libre 2 System, FreeStyle Libre 3 System
2022-05-26 K213996 Abbott Diabetes Care, Inc. FreeStyle Libre 3 Continuous Glucose Monitoring System
2022-05-26 K212132 Abbott Diabetes Care, Inc. FreeStyle Libre 3 Continuous Glucose Monitoring System
2021-11-22 K210943 Abbott Diabetes Care, Inc. FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
2021-08-11 K211102 Abbott Diabetes Care, Inc. FreeStyle Libre 2 Flash Glucose Monitoring System
2021-07-30 K201761 Abbott Diabetes Care, Inc. FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
2021-05-07 K202145 Bigfoot Biomedical, Inc. Bigfoot Unity Diabetes Management System
2020-06-12 K193371 Abbott Diabetes Care, Inc. FreeStyle Libre 2 Flash Glucose Monitoring System
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence