Product code PZI— Clinical Chemistry
StatStrip Xpress 2 Glucose Hospital Meter System
- Classification name
- Prescription Use Blood Glucose Meter For Near-Patient Testing
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Total cleared
- 14
- First cleared
- Most recent
FDA classification 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.”
Market context for product code PZI
FDA has cleared devices under product code PZI between 2014 and 2026, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2026
- 2024
- 2022
- 2018
- 2017
- 2016
- 2015
- 2014
Top applicants under product code PZI
Recent clearances under product code PZI
- K252323 — cobas pulse blood glucose monitoring system
- K221349 — XPER Technology PREMIUM Pro Blood Glucose Monitoring System
- K220272 — cobas pulse blood glucose monitoring system
- K232075 — StatStrip Glucose Hospital Meter System
- K200788 — Assure Titanium Blood Glucose Monitoring System
- K182549 — StatStrip Xpress 2 Glucose Hospital Meter System
- K182552 — StatStrip Xpress Glucose Hospital Meter System
- K181043 — StatStrip Glucose Hospital Meter System
- K163490 — StatStrip Xpress 2 Glucose Hospital Meter System
- K161856 — StatStrip Xpress Glucose Hospital Meter System
- K152986 — StatStrip Xpress 2 Glucose Hospital Meter System
- K150461 — StatStrip Xpress Glucose Hospital Meter System
- K150281 — StatStrip Glucose Hospital Meter
- K132121 — STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.