PZI — Prescription Use Blood Glucose Meter For Near-Patient Testing Class II
FDA product code PZI covers "Prescription Use Blood Glucose Meter For Near-Patient Testing", a Class II medical device regulated under 21 CFR 862.1345. Submissions are reviewed by the Clinical Chemistry panel. At least 14 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PZI
- Device Class
- Class II
- Regulation Number
- 862.1345
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Definition
Intended for use in near-patient testing settings for in vitro diagnostic, multiple-patient use for the quantitative determination of glucose throughout all hospital and all professional healthcare settings for use in determining dysglycemia.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252323 | roche diagnostics | cobas pulse blood glucose monitoring system | June 12, 2026 |
| K221349 | taidoc technology corporation | XPER Technology PREMIUM Pro Blood Glucose Monitoring System | November 19, 2024 |
| K220272 | roche diagnostics | cobas pulse blood glucose monitoring system | April 26, 2024 |
| K232075 | nova biomedical corporation | StatStrip Glucose Hospital Meter System | February 23, 2024 |
| K200788 | arkray | Assure Titanium Blood Glucose Monitoring System | May 23, 2022 |
| K182552 | nova biomedical corporation | StatStrip Xpress Glucose Hospital Meter System | December 13, 2018 |
| K182549 | nova biomedical corporation | StatStrip Xpress 2 Glucose Hospital Meter System | December 13, 2018 |
| K181043 | nova biomedical corporation | StatStrip Glucose Hospital Meter System | July 12, 2018 |
| K163490 | nova biomedical corporation | StatStrip Xpress 2 Glucose Hospital Meter System | January 6, 2017 |
| K161856 | nova biomedical corporation | StatStrip Xpress Glucose Hospital Meter System | November 15, 2016 |
| K152986 | nova biomedical corporation | StatStrip Xpress 2 Glucose Hospital Meter System | January 27, 2016 |
| K150461 | nova biomedical corporation | StatStrip Xpress Glucose Hospital Meter System | May 20, 2015 |
| K150281 | nova biomedical corporation | StatStrip Glucose Hospital Meter | May 6, 2015 |
| K132121 | nova biomedical corporation | STATSTRIP GLUCOSE HOSPITAL METER SYSTEM | September 24, 2014 |