# K232075: StatStrip Glucose Hospital Meter System

- Pathway: 510(k) (Dual Track)
- Applicant: Nova Biomedical Corporation
- Decided: Feb 23, 2024 after 226 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: 3 (3 Class I)
- 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.
1 of 6 devices in its family (counting itself) has 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 5.

## Recalls of this device
- Jul 29, 2026 · Class I · Z-3129-2026: A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient ide
- Jul 29, 2026 · Class I · Z-3128-2026: A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient ide
- Nov 20, 2024 · Class I · Z-0681-2025: A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose patient test results to a healthcare institution's data management system (DMS) at healthca

## 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 neonatal 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 neonatal 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. The StatStrip Glucose Hospital Meter System includes the following components: - StatStrip Glucose Hospital Meter - StatStrip Glucose Test Strips

Source page: https://510kreport.com/device/K232075
Methodology: https://510kreport.com/methodology