510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QLGClass II

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

21 CFR 862.1355 / Clinical Chemistry
FDA source (opens on fda.gov)

QLG is the FDA product code for Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems, a class II device type, regulated under 21 CFR 862.1355. FDA's definition for this code reads: "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...". As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and 10 recalls.

Classification record

Product code
QLG
Device name
Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
FDA 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.
Regulation
21 CFR 862.1355
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
9
Ingested recalls
10

Clearances, product code QLG

By decision year
9 clearances under product code QLG with a decision year between 2020 and 2023, 2021 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code QLG by decision year
YearClearances
20201
20214
20222
20232

Applicants with the most clearances

Product code QLG
Applicants holding the most 510(k) clearances under product code QLG
ApplicantClearances
Abbott Medical7
Bigfoot Biomedical, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order