CFR · Hexokinase, Glucose
Clinical Chemistry · 21 CFR 862.1345 · Class 2
Overview
| Product Code | CFR |
|---|---|
| Device Name | Hexokinase, Glucose |
| Regulation | 21 CFR 862.1345 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
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 145)
Showing 20 most recent of 145 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions | Roche Diagnostics | Feb 12, 2026 | SESE |
| K252357 | Glucose2 | Abbott Ireland | Oct 24, 2025 | SESE |
| K220134 | cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH | Roche Diagnostics | Sep 16, 2022 | SESE |
| K191899 | Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions | Roche Diagnostics | Aug 16, 2019 | SESE |
| K170316 | ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM | Abbott Laboratories | Oct 19, 2017 | SESE |
| K153644 | ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II | Elitechgroup | Sep 7, 2016 | SESE |
| K151487 | Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method | Diatron U.S., Inc. | Jan 14, 2016 | SESE |
| K131189 | UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH) | Beckman Coulter, Inc. | Apr 17, 2014 | SESE |
| K123018 | ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE | Alfa Wassermann Diagnostic Technologies, Inc. | Apr 23, 2013 | SESE |
| K120681 | ADVIA CHEMISTRY GLUH_3 REAGENTS | Siemens Healthcare Diagnostics, Inc. | May 15, 2012 | SESE |
| K120369 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU) | Hitachi Chemical Diagnostics, Inc. | May 10, 2012 | SESE |
| K112377 | BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Mar 23, 2012 | SESE |
| K113131 | LIASYS 450 | Ams | Mar 8, 2012 | SESE |
| K103531 | PRESTIGE 24I; BIOLIS 24I; MGC 240 | Tokyo Boeki Medisys, Inc. | Dec 1, 2011 | SESE |
| K103788 | PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT | HORIBA ABX SAS | Nov 8, 2011 | SESE |
| K101854 | ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429 | Siemens Healthcare Diagnostics | Mar 7, 2011 | SESE |
| K092603 | COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY | Roche Diagnostics | Dec 4, 2009 | SESE |
| K090703 | POLY-CHEM 90 GLUCOSE | Polymedco, Inc. | Oct 20, 2009 | SESE |
| K092506 | EASYRA GLU-H REAGENT, MODEL 10200 | Medica Corp. | Sep 16, 2009 | SESE |
| K081276 | ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H | Horiba Abx | Sep 12, 2008 | SESE |
Top Applicants
- Em Diagnostic Systems, Inc. — 7 clearances
- Abbott Laboratories — 6 clearances
- Harleco — 6 clearances
- Heraeus Kulzer, Inc. — 6 clearances
- Data Medical Associates, Inc. — 4 clearances
