# K061830: Stat Profile Critical Care Xpress (CCX), Model 1+

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corp.
- Decided: Nov 1, 2006 after 126 days
- Product code: CIG (Diazo Colorimetry, Bilirubin)
- Device class: 2
- Regulation: 21 CFR 862.1110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 1 cites 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K110648: Nova Stat Profile Phox Ultra Analyzer System (2011), 16 descendants of its own
- 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

## Indications for use
The Stat Profile Critical Care Xpress Analyzer is intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, P02, S02%, Hematocrit (Hct), total Hemoglobin (tub), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (Met-b), Reduced Hemoglobin (HHb), Oxygen content (O2Ct), Oxygen capacity (O2Cap), and total Bilirubin (tBil) in heparinized whole blood; Na+, 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 intended use of the Nova Stat Profile Critical Care Xpress CO-Oximeter Calibrator Cartridge with Bilirubin and Deproteinizing Solution is for the quantitative determination of total hemoglobin, oxyhemoglobin, carboxyhemoglobin, methemoglobin, deoxyhemoglobin and total bilirubin in human blood using the Stat Profile Critical Care Xpress CO-Oximeter Analyzer. Nova Stat Profile Critical Care Xpress CO-Oximeter Controls and Autocartridge QC are intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Nova Biomedical Stat Profile Critical Care Xpress Analyzers.

Source page: https://510kreport.com/device/K061830
Methodology: https://510kreport.com/methodology