# K100602: Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corp.
- Decided: Aug 17, 2011 after 532 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: 2 generations back to K913806 (1991). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980908: Lactate Pro System, Kdk Corp. (1998) Summary page 1.
- K023567: Stat Profile Phox Plus L Analyzer, Nova Biomedical Corp. (2002) Summary page 1.
- K012058: Stat Profile Phox Plus L Analyzer, Nova Biomedical Corp. (2001) Summary page 1.

## Most influential descendants
- K112955: Nova Statstrip Lactate Hospital Meter System (2012), 0 descendants of its own

## Indications for use
Meter: 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 selling for clinical and for point-of-care usage for the quantitative determination of Lactate (Lac) in fresh venous and arterial whole blood specimens as anaid to evaluate the acid-base status of patients suspected of having lactic acidosis. It isnot for use on capillary blood specimens. Itis intended to provide plasma equivalent results to laboratory methods. Test Statrip ctt Test Strips are intended for use only with the Nova StatStrip Lactate Hospital Meter for quantitative determination of lactate infresh venous and arterial whole blood specimens. Itis 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). Control Solutions; Nova StatStrip Lactate Control Solutions are intended far use writh 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/K100602
Methodology: https://510kreport.com/methodology