# K022746: Stat Profile Critical Care Xpress Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corp.
- Decided: Nov 22, 2002 after 95 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: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Aug 11, 2008 · Not classified · Z-1328-2009: Erroneous, low creatinine results on CCX analyzer
- Jan 27, 2006 · Not classified · Z-0577-06: Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs
- Mar 30, 2004 · Not classified · Z-0826-04: Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems
- Sep 22, 2003 · Not classified · Z-0061-04: Degradation of the magnesium sensor could result in low ionozed magnesium patient samples

## 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, PC02, P0:2, S02%, Hematocrit (Hct), Catt, total Hemoglobin (tHb), Oxyhemoglobin (02Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), Reduced Hemoglobin (HHb), Oxygen content (02Ct), and Oxygen capacity (OZCap) in heparinized whole blood; Na+, K+, C1-, CaH, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma.

Source page: https://510kreport.com/device/K022746
Methodology: https://510kreport.com/methodology