Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

StatStrip Xpress 2 Glucose Hospital Meter System

K-Number: K182549 · 2018-12-13

ApplicantNova Biomedical Corporation
Decision Date2018-12-13
Product CodePZI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

StatStrip Xpress 2 Glucose Hospital Meter System is a medical device manufactured by Nova Biomedical Corporation. It received FDA 510(k) clearance on 2018-12-13 under approval number K182549. The device is classified under product code PZI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StatStrip Xpress 2 Glucose Hospital Meter System?

StatStrip Xpress 2 Glucose Hospital Meter System is a medical device that received FDA 510(k) clearance on 2018-12-13. It is manufactured by Nova Biomedical Corporation. The 510(k) number is K182549.

When was StatStrip Xpress 2 Glucose Hospital Meter System approved by the FDA?

StatStrip Xpress 2 Glucose Hospital Meter System received FDA 510(k) clearance on 2018-12-13, under approval number K182549.

What company makes StatStrip Xpress 2 Glucose Hospital Meter System?

StatStrip Xpress 2 Glucose Hospital Meter System is manufactured by Nova Biomedical Corporation.

What is the FDA product code for StatStrip Xpress 2 Glucose Hospital Meter System?

The FDA product code for StatStrip Xpress 2 Glucose Hospital Meter System is PZI.

Related Clinical Trials

NCT07092761 Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING

Related PubMed Literature

PMID: 41608759 Collaborative and Cooperative Hospital "In-House" Medical Device Development and Implementation in the AI Age: The European Responsible AI Development (EURAID) Framework Compatible With European Values. Journal of medical Internet research (2026) PMID: 41491965 From stones to system: integrating kidney stones disease into the cardiovascular-kidney-metabolic continuum. Current opinion in nephrology and hypertension (2026) PMID: 41443207 Artificial Intelligence in UK Hospital Medicine: From Innovation to Implementation. British journal of hospital medicine (London, England : 2005) (2025) PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

Other Devices by Nova Biomedical Corporation

K161856StatStrip Xpress Glucose Hospital Meter System K160156StatStrip Xpress Blood Glucose Monitoring System K152986StatStrip Xpress 2 Glucose Hospital Meter System K170464StatStrip Xpress Blood Glucose Monitoring System K171059Nova StatSensor Creatinine Hospital Meter System K160990Nova Max Uric Acid Monitoring System

View all 27 devices →

Related Devices (Code: PZI)

K161856StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation K152986StatStrip Xpress 2 Glucose Hospital Meter SystemNova Biomedical Corporation K163490StatStrip Xpress 2 Glucose Hospital Meter SystemNova Biomedical Corporation K182552StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation K181043StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation K200788Assure Titanium Blood Glucose Monitoring SystemArkray, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑