NBW · System, Test, Blood Glucose, Over The Counter
Clinical Chemistry · 21 CFR 862.1345 · Class 2
Overview
| Product Code | NBW |
|---|---|
| Device Name | System, Test, Blood Glucose, Over The Counter |
| Regulation | 21 CFR 862.1345 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Classification Rationale
Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (20 of 508)
Showing 20 most recent of 508 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System | ACON Laboratories, Inc. | Oct 10, 2025 | SESE |
| K243060 | TeleRPM Gen2 Blood Glucose Monitoring System | Guangdong Transtek Medical Electronics Co., Ltd. | Jan 30, 2025 | SESE |
| K240637 | RIGHTEST Blood Glucose Monitoring System Max Tel | Bionime Corporation | Nov 4, 2024 | SESE |
| K240640 | Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System | Sejoy Biomedical Co., Ltd. | Oct 8, 2024 | SESE |
| K241787 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System | Ascensia Diabetes Care U.S., Inc. | Aug 27, 2024 | SESE |
| K222126 | VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose Monitoring System, VivaChek Fad Sync Blood Glucose Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd. | Aug 16, 2024 | SESE |
| K241304 | WaveSense Jazz Blood Glucose Monitoring System | Agamatrix | Jun 6, 2024 | SESE |
| K231679 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System | Ascensia Diabetes Care | Feb 23, 2024 | SESE |
| K231192 | RIGHTEST Blood Glucose Monitoring System Max Tel | Bionime Corporation | Jan 19, 2024 | SESE |
| K233058 | VivaChek Link Plus Blood Glucose Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd. | Dec 22, 2023 | SESE |
| K231476 | TRUENESS AIR Blood Glucose Monitoring System; TRUENESS Blood Glucose Monitoring System | Sinocare, Inc. | Dec 1, 2023 | SESE |
| K230625 | ReliOn Premier BLU Blood Glucose Monitoring System | I-Sens, Inc. | Aug 10, 2023 | SESE |
| K213131 | Accu-Chek Guide Solo diabetes manager blood glucose monitoring system | Roche Diabetes Care GmbH | Aug 10, 2023 | SESE |
| K223722 | MIO Blood Glucose Monitoring System | Mio Labs, Inc. | Jun 28, 2023 | SESE |
| K222234 | GlucoSure ADVANCE Link Blood Glucose Monitoring System | Apex BioTechnology Corp. | Dec 21, 2022 | SESE |
| K223293 | CONTOUR® NEXT GEN Blood Glucose Monitoring System | Ascensia Diabetes Care U.S., Inc. | Nov 18, 2022 | SESE |
| K220421 | BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System | Apex BioTechnology Corp. | Nov 4, 2022 | SESE |
| K213061 | SuperCheck Pro Blood Glucose Monitoring System | Ok Biotech Co., Ltd. | Oct 7, 2022 | SESE |
| K212248 | GlucoLeader Enhance 2 Blood Glucose Monitoring System | Hmd Biomedical, Inc. | Aug 29, 2022 | SESE |
| K212140 | GlucoSure Link Blood Glucose Monitoring System | Apex BioTechnology Corp. | Aug 25, 2022 | SESE |
Top Applicants
- Taidoc Technology Corporation — 65 clearances
- I-Sens, Inc. — 21 clearances
- Abbott Diabetes Care, Inc. — 18 clearances
- Apex BioTechnology Corp. — 18 clearances
- Bionime Corporation — 18 clearances
