# K112955: Nova Statstrip Lactate Hospital Meter System

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corporation
- Decided: Jan 5, 2012 after 93 days
- Product code: KHP (Acid, Lactic, Enzymatic Method)
- Device class: 1
- Regulation: 21 CFR 862.1450
- 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 K913806 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100602: Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test Strips, Nova Biomedical Corp. (2011) Summary page 2.

## Indications for use
The Nova StatStrip Lactate Hospital Meter System is intended for in vitro diagnostic use by healthcare professionals for multiple patient use in a professional healthcare setting for clinical and for point-of-care usage for the quantitative determination of Lactate (Lac) in fresh venous and arterial whole blood specimens as an aid to evaluate the acid-base status of patients suspected of having lactic acidosis. It is not for use on capillary blood specimens. It is intended to provide plasma equivalent results to laboratory methods. Nova StatStrip Lactate Test Strips are intended for use only with the Nova StatStrip Lactate Hospital Meter for quantitative determination of lactate in fresh venous and arterial whole blood specimens. It is not for use on capillary blood specimens. The performance characteristics of the device for lactate measurements on capillary specimens have not been established. Nova StatStrip Lactate Test Strips are for testing outside the body (in vitro diagnostic use only). Nova StatStrip Lactate Control Solutions are intended for use with the Nova StatStrip Lactate Hospital Meter and Nova StatStrip Lactate Test Strips as a quality control check to verify the accuracy of blood lactate test results. There are 2 levels of controls, (Levels 1 and Level 2). Nova StatStrip Lactate Linearity Kit solutions are used to check the linearity of the Nova StatStrip Lactate Hospital Meter. There are 4 levels of lactate linearity solutions: Level 1, Level 2, Level 3, and Level 4.

Source page: https://510kreport.com/device/K112955
Methodology: https://510kreport.com/methodology