# K181043: StatStrip Glucose Hospital Meter System

- Pathway: 510(k) (Dual Track)
- Applicant: Nova Biomedical Corporation
- Decided: Jul 12, 2018 after 84 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.
4 later devices descend from it; 4 cite it directly.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150281: StatStrip Glucose Hospital Meter, Nova Biomedical Corporation (2015) Summary page 4.

## Most influential descendants
- K252323: cobas pulse blood glucose monitoring system (2026), 0 descendants of its own
- K232075: StatStrip Glucose Hospital Meter System (2024), 0 descendants of its own
- K182552: StatStrip Xpress Glucose Hospital Meter System (2018), 0 descendants of its own
- K182549: StatStrip Xpress 2 Glucose Hospital Meter System (2018), 0 descendants of its own

## Indications for use
The StatStrip 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 nconate heel stick. It is not intended for use with nconate 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/K181043
Methodology: https://510kreport.com/methodology