CGA · Glucose Oxidase, Glucose
Clinical Chemistry · 21 CFR 862.1345 · Class 2
Overview
| Product Code | CGA |
|---|---|
| Device Name | Glucose Oxidase, 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 400)
Showing 20 most recent of 400 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K210933 | YSI 2900C Biochemistry Analyzer | Ysi, Inc. | Sep 30, 2024 | SESE |
| K220328 | EasyStat 300 | Medica Corporation | Jul 26, 2024 | SESE |
| K223179 | Cholestech LDX System | Alere San Diego, Inc. | Sep 20, 2023 | SESE |
| K223755 | i-STAT G cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | Sep 11, 2023 | SESE |
| K223710 | i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | Jul 28, 2023 | SESE |
| K223090 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | Jan 27, 2023 | SESE |
| K203549 | Nova Primary Glucose Analyzer System | Nova Biomedical Corporation | Oct 18, 2022 | SESE |
| K210958 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | Aug 13, 2021 | SESE |
| K200349 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | Mar 13, 2020 | SESE |
| K183678 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | Feb 7, 2020 | SESE |
| K190520 | VITROS XT Chemistry Products GLU-Ca Slides | Ortho-Clinical Diagnostics, Inc. | Apr 3, 2019 | SESE |
| K183546 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | Feb 16, 2019 | SESE |
| K182781 | PTS Professional Chemistry Kit | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | Dec 21, 2018 | SESK |
| K180340 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | Sep 26, 2018 | SESE |
| K163433 | VITROS Chemistry Products GLU Slides | Ortho Clinical Diagnostics | Sep 18, 2017 | SESE |
| K163271 | i-Stat Alinity System with i-Stat Glucose test | Abbott Point of Care, Inc. | Apr 10, 2017 | SESE |
| K162282 | CardioChek Plus Test System, CardioChek Home Test System | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | Dec 22, 2016 | SESE |
| K160402 | GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) | Instrumentation Laboratory CO | Dec 14, 2016 | SESE |
| K161818 | GEM Premier 3000 | Instrumentation Laboratory CO | Sep 14, 2016 | SESE |
| K153692 | Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer | Infrared Laboratory Systems, LLC (Dba Synermed) | Jun 24, 2016 | SESE |
Top Applicants
- Lifescan, Inc. — 21 clearances
- Boehringer Mannheim Corp. — 17 clearances
- Apex BioTechnology Corp. — 14 clearances
- Miles Laboratories, Inc. — 12 clearances
- Medisense, Inc. — 11 clearances
