LFR · Glucose Dehydrogenase, Glucose
Clinical Chemistry · 21 CFR 862.1345 · Class 2
Overview
| Product Code | LFR |
|---|---|
| Device Name | Glucose Dehydrogenase, 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 73)
Showing 20 most recent of 73 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K152328 | FreeStyle InsuLinx Blood Glucose Monotioring System | Abott Laboratories | Sep 17, 2015 | SESE |
| K142089 | ACCU-CHEK AVIVA EXPERT SYSTEM | Roche Diagnostics Corporation | Dec 17, 2014 | SESE |
| K133537 | EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM | Eps Bio Technology Corp. | Apr 28, 2014 | SESE |
| K131727 | CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM | Ceragem Medisys, Inc. | Feb 28, 2014 | SESE |
| K131366 | ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM | Roche Diagnostics Operations, Inc. | Oct 11, 2013 | SESE |
| K122688 | NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR | Nova Biomedical Corporation | Apr 4, 2013 | SESE |
| K121433 | GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS | Hmd Biomedical, Inc. | Feb 14, 2013 | SESE |
| K122435 | NOVA ONE BLOOD GLUCOSE MONITOR | Nova Biomedical Corporation | Dec 20, 2012 | SESE |
| K113314 | PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM | Hmd Biomedical, Inc. | Nov 9, 2012 | SESE |
| K121224 | GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM | Taidoc Technology Corporation | Sep 19, 2012 | SESE |
| K113307 | GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM | Hmd Biomedical, Inc. | Jul 27, 2012 | SESE |
| K121190 | CONTOUR NEXT BLOOD GLUCOSE METER | Bayer Healthcare, LLC | Jul 26, 2012 | SESE |
| K120042 | TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM | Taidoc Technology Corporation | May 22, 2012 | SESE |
| K121207 | EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM | Eps Bio Technology Corp. | May 18, 2012 | SESE |
| K113768 | U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM | Taidoc Technology Corporation | Apr 12, 2012 | SESE |
| K113243 | EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM | Eps Bio Technology Corp. | Mar 28, 2012 | SESE |
| K110894 | CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER | Bayer Healthcare | Mar 28, 2012 | SESE |
| K110587 | CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW) | Bayer Healthcare, LLC | Mar 28, 2012 | SESE |
| K111268 | CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM | Bayer Healthcare | Mar 6, 2012 | SESE |
| K111874 | FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS | Abbott Laboratories | Feb 16, 2012 | SESE |
Top Applicants
- Roche Diagnostics Corp. — 10 clearances
- Boehringer Mannheim Corp. — 9 clearances
- Eps Bio Technology Corp. — 6 clearances
- Abbott Diabetes Care, Inc. — 5 clearances
- Abbott Laboratories — 4 clearances
