# K182552: StatStrip Xpress Glucose Hospital Meter System

- Pathway: 510(k) (Dual Track)
- Applicant: Nova Biomedical Corporation
- Decided: Dec 13, 2018 after 87 days
- Product code: PZI (Prescription Use Blood Glucose Meter For Near-Patient Testing)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K060345 (2006). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181043: StatStrip Glucose Hospital Meter System, Nova Biomedical Corporation (2018) Summary page 4.

## Indications for use
The StatStrip Xpress Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood, and neonate heel stick specimens throughout all hospital and all professional healthcare settings, including patients receiving intensive medical intervention/therapy. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia.

Source page: https://510kreport.com/device/K182552
Methodology: https://510kreport.com/methodology