# K152986: StatStrip Xpress 2 Glucose Hospital Meter System

- Pathway: 510(k) (Special)
- Applicant: Nova Biomedical Corporation
- Decided: Jan 27, 2016 after 110 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: 3 generations back to K060345 (2006). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150461: StatStrip Xpress Glucose Hospital Meter System, Nova Biomedical Corporation (2015) Summary page 4.

## Most influential descendants
- K163490: StatStrip Xpress 2 Glucose Hospital Meter System (2017), 0 descendants of its own

## Indications for use
The StatStrip Xpress 2 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. The StatStrip Xpress 2 Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick and neonatal arterial samples throughout all hospital and all professional healthcare settings. 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/K152986
Methodology: https://510kreport.com/methodology