PZI · Prescription Use Blood Glucose Meter For Near-Patient Testing
Clinical Chemistry · 21 CFR 862.1345 · Class 2
Overview
| Product Code | PZI |
|---|---|
| Device Name | Prescription Use Blood Glucose Meter For Near-Patient Testing |
| 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 (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K221349 | XPER Technology PREMIUM Pro Blood Glucose Monitoring System | Taidoc Technology Corporation | Nov 19, 2024 | SESE |
| K220272 | cobas pulse blood glucose monitoring system | Roche Diagnostics | Apr 26, 2024 | SESE |
| K232075 | StatStrip Glucose Hospital Meter System | Nova Biomedical Corporation | Feb 23, 2024 | SESE |
| K200788 | Assure Titanium Blood Glucose Monitoring System | Arkray, Inc. | May 23, 2022 | SESE |
| K182552 | StatStrip Xpress Glucose Hospital Meter System | Nova Biomedical Corporation | Dec 13, 2018 | SESE |
| K182549 | StatStrip Xpress 2 Glucose Hospital Meter System | Nova Biomedical Corporation | Dec 13, 2018 | SESE |
| K181043 | StatStrip Glucose Hospital Meter System | Nova Biomedical Corporation | Jul 12, 2018 | SESE |
| K163490 | StatStrip Xpress 2 Glucose Hospital Meter System | Nova Biomedical Corporation | Jan 6, 2017 | SESE |
| K161856 | StatStrip Xpress Glucose Hospital Meter System | Nova Biomedical Corporation | Nov 15, 2016 | SESE |
| K152986 | StatStrip Xpress 2 Glucose Hospital Meter System | Nova Biomedical Corporation | Jan 27, 2016 | SESE |
| K150461 | StatStrip Xpress Glucose Hospital Meter System | Nova Biomedical Corporation | May 20, 2015 | SESE |
| K150281 | StatStrip Glucose Hospital Meter | Nova Biomedical Corporation | May 6, 2015 | SESE |
| K132121 | STATSTRIP GLUCOSE HOSPITAL METER SYSTEM | Nova Biomedical Corporation | Sep 24, 2014 | SESE |
Top Applicants
- Nova Biomedical Corporation — 10 clearances
- Arkray, Inc. — 1 clearance
- Roche Diagnostics — 1 clearance
- Taidoc Technology Corporation — 1 clearance
