# K110648: Nova Stat Profile Phox Ultra Analyzer System

- Pathway: 510(k) (Special)
- Applicant: Nova Biomedical Corporation
- Decided: Aug 29, 2011 after 178 days
- Product code: CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph)
- Device class: 2
- Regulation: 21 CFR 862.1120
- 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 K061830 (2006). 1 ancestor in all.
16 later devices descend from it; 9 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061830: Stat Profile Critical Care Xpress (CCX), Model 1+, Nova Biomedical Corp. (2006) Summary page 2.

## Most influential descendants
- K131703: Nova Stat Profile Prime CCS Analyzer System (2014), 3 descendants of its own
- K180428: Stat Profile Prime Plus Analyzer System (2018), 2 descendants of its own
- K200403: Stat Profile Prime Plus Analyzer System (2020), 1 descendant of its own
- K180340: Stat Profile Prime Plus Analyzer System (2018), 1 descendant of its own
- K180186: Stat Profile Prime Plus Analyzer System (2018), 1 descendant of its own

## Indications for use
The Nova Stat Profile pHOx Ultra Analyzer with CO-Oximeter is intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PC02, P02, S02%, Hematocrit (Hct), total Hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), Deoxyhemoglobin (HHb), and total bilirubin (tBil) in heparinized whole blood; Nat, K'-, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma. Total Bilirubin (tBil) was not evaluated on neonatal samples. The Nova Stat Profile pHOx Ultra Analyzer without CO-Oximeter is intended for in vitro diagnostic use by health care professionals and/or point-of-care usage in the quantitative determination of pH, PC02, P02, S02%, Hematocrit (Hct), Hemoglobin (Hb) in heparinized whole blood; Na+, K'-, CI-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Utea), and Creatinine (Great) in helparinized whole blood, serum, or plasma. The intended use of the Nova STP pHOx Ultra Calibrator Cartridge isfor the quantitative determination of pH, PC02, P02, S02%, Hematocrit (Hct), Hemoglobin (Hb) in heparinized whole blood; Na'-, K+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Great) in heparinized whole blood, serum, or plasma. The intended use of the Nova Stat Profile pHOx Ultra Analyzer CO-Oximeter Calibrator Cartridge with Bilirubin and Deproteinizing Solution is for the quantitative determination of total Hemoglobin (tHb), Oxyhemoglobin (O2H-b), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), Deoxyhemoglobin (HHb), and total bilirubin (tBil) in human blood using the Nova Stat Profile pHOx Ultra Analyzer System with CO-Oximeter. Nova Stat Profile pHOx Ultra Analyzer CO-Oximeter Controls and Autocartridge QG are intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Nova Stat Profile pHOx Ultra Analyzer.

Source page: https://510kreport.com/device/K110648
Methodology: https://510kreport.com/methodology