# K063821: Nova Statstrip Glucose Hospital Meter System

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corp.
- Decided: Jan 24, 2007 after 29 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 2 cite it directly.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K132121: Statstrip Glucose Hospital Meter System (2014), 12 descendants of its own
- 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

## Recalls of this device
- Oct 10, 2013 · Class II · Z-0650-2014: Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage
- Feb 25, 2013 · Class II · Z-1153-2013: Glucose test strips reports no result message when tested
- Feb 25, 2013 · Class II · Z-1154-2013: Glucose test strips reports no result message when tested
- Feb 12, 2010 · Not classified · Z-1783-2010: Glucose strips report low glucose results

## Indications for use
The Nova StatStrip Glucose Hospital Meter System is intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of glucose in capillary, venous, arterial, and neonate whole blood. It is indicated for use in a clinical setting by healthcare professionals as an aid to monitor the effectiveness of diabetes control. Nova StatStrip Glucose Test Strips are intended for use only with the StatStrip Glucose Hospital Meter for quantitative tests. The glucose meter is intended to quantitatively measure glucose (sugar) in whole blood. The Glucose Meter is calibrated to provide plasma equivalent results to laboratory methods. Nova StatStrip Glucose Test Strips are for testing outside the body (in vitro diagnostic use only). Nova StatStrip Control Solutions is intended for use with the Nova StatStrip Glucose Hospital Meter and Nova StatStrip Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. There are three levels of controls, (Level 1, Level 2, and Level 3). These solutions will be offered for sale separately from the meter. Nova StatStrip Glucose Linearity Kit solutions are used to check the linearity of the Nova StatStrip Glucose Hospital Meter System. There are five levels of linearity solutions, (Level 1, Level 2, Level 3, Level 4, and Level 5).

Source page: https://510kreport.com/device/K063821
Methodology: https://510kreport.com/methodology