# K132121: Statstrip Glucose Hospital Meter System

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corporation
- Decided: Sep 24, 2014 after 441 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: 1 generation back to K060345 (2006). 2 ancestors in all.
12 later devices descend from it; 3 cite it directly.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063821: Nova Statstrip Glucose Hospital Meter System, Nova Biomedical Corp. (2007) Summary page 6.
- K060345: Nova Statstrip Glucose Hospital Meter, Statstrip Control Solutions, Nova Biomedical Corp. (2006) Summary page 6.

## Most influential descendants
- K150281: StatStrip Glucose Hospital Meter (2015), 5 descendants of its own
- K181043: StatStrip Glucose Hospital Meter System (2018), 4 descendants of its own
- K150461: StatStrip Xpress Glucose Hospital Meter System (2015), 3 descendants of its own
- K200788: Assure Titanium Blood Glucose Monitoring System (2022), 1 descendant of its own
- K152986: StatStrip Xpress 2 Glucose Hospital Meter System (2016), 1 descendant 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. The StatStrip 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 whole blood 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/K132121
Methodology: https://510kreport.com/methodology