# K070068: Nova Statsensor Creatinine Hospital Meter, Control Solutions,Linearity Solutions, and Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corp.
- Decided: May 7, 2007 after 119 days
- Product code: CGL (Electrode, Ion Based, Enzymatic, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have 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
- K171059: Nova StatSensor Creatinine Hospital Meter System (2017), 2 descendants of its own
- K261039: i-STAT Crea cartridge with the i-STAT 1 System (2026), 0 descendants of its own
- K251281: Nova Max Creat eGFR Monitoring System (2026), 0 descendants 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 21, 2008 · Not classified · Z-1472-2008: Lithium batteries may fail if the glucose or creatinine meters have been dropped.
- Nov 2, 2007 · Not classified · Z-0725-2008: Incorrect Results - Creatinine results were lower than the laboratory reference method.
- Nov 2, 2007 · Not classified · Z-0726-2008: Incorrect Results - Creatinine results were lower than the laboratory reference method.
- Nov 2, 2007 · Not classified · Z-0724-2008: Incorrect Results - Creatinine results were lower than the laboratory reference method.

## Indications for use
The Nova StatSensor Creatinine Hospital Meter is intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of creatinine in capillary, venous, and arterial whole blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis. Not for use in neonates. Nova StatSensor Creatinine Test Strips are intended for use only with the StatSensor Creatinine Hospital Meter for quantitative tests. The Nova StatSensor Creatinine Hospital Meter is intended to quantitatively measure creatinine in whole blood. The Creatinine Meter is calibrated to provide plasma equivalent results to laboratory methods. Nova StatSensor Creatinine Test Strips are for testing outside the body (in vitro diagnostic use only). Nova StatSensor Creatinine Control Solutions are intended for use with the Nova StatSensor Creatinine Hospital Meter and Nova StatSensor Creatinine Test Strips as a quality control check to verify the accuracy of blood creatinine 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 StatSensor Creatinine Linearity Kit solutions are used to check the linearity of the Nova StatSensor Creatinine 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/K070068
Methodology: https://510kreport.com/methodology