# K020297: Stat Profile Critical Care Xpress Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corp.
- Decided: Jun 10, 2002 after 133 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: 1 (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
- Jan 27, 2006 · Not classified · Z-0576-06: Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs

## Indications for use
The Stat Profile Critical Care Xpress Analyzer is intended for in vitro diagnostic use by health care professionals for the quantitative determination of pH, pC02, p02, S02%, Hct, Hb, Na+, K+, CI-, Ca++, Mg++, Glu, BUN, Lac and Creat in heparinized whole blood, and Na+, K+, CI-, Ca++, Mg++, Glu, BUN, Lac and Creat in serum and plasma. The following list includes the clinical utility information for each of the analytes measured on the CCX Analyzer. Blood Gases (PCO,, PO2 and pH): Whole blood measurement of blood gases is used in the diagnosis, and treatment of life-threatening acid-base disturbances in critically ill patients with numerous metabolic and pulmonary diseases. Oxygen Saturation: Used to assess the oxygenation of hemoglobin and the adequacy of tissue oxygenation in the evaluation of pulmonary function. Also used in the diagnosis and treatment of cyanosis. Hematocrit: Whole blood measurement of hematocrit is used to estimate that red blood cells are present in sufficient quantity to carry oxygen and carbon dioxide. Hemoglobin: Oxygen is carried from the lungs throughout the body by hemoglobin present in red blood cells. Measurement of hemoglobin provides the clinician with information regarding the evaluation of chronic and acute anemias and also with information pertaining to the potential oxygen transport capability of the hemoglobin. Sodium: Measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison’s disease, dehydration, or diseases involving electrolyte imbalance. Potassium: Measurement of potassium is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels. Chloride: Measurement of chloride is used in the diagnosis and treatment of electrolyte and metabolic disorders such as, cystic fibrosis and diabetic acidosis. Ionized Calcium: Used in the diagnosis and treatment of hypertension, renal disease, and vitamin D related disorders. Also useful in the diagnosis and treatment of patients with increased total protein and/or albumin levels, as in dehydration. Ionized Magnesium: Measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium). Creatinine: Measurement of creatinine is used in the diagnosis and treatment of certain renal conditions and is used for monitoring adequacy of dialysis, for example, peritoneal dialysis and peritoneal equilibration testing. Glucose: Measurement of glucose is used in the diagnosis and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. Lactate: Measurement of lactic acid (lactate) in whole blood, serum, and plasma is used to evaluate the acid-base status of patients suspected of having lactic acidosis. Urea Nitrogen: Measurement of urea nitrogen is used in the diagnosis and treatment of certain renal and metabolic diseases.

Source page: https://510kreport.com/device/K020297
Methodology: https://510kreport.com/methodology