(126 days)
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, PO2, SO2%, Hematocrit (Hct), total Hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), Reduced Hemoglobin (HHb), Oxygen content (O2Ct), Oxygen capacity (02Cap), and total Bilirubin (tBil) in heparinized whole blood; Na+, K+, Cl-, Ca++, Mg++, Glucose (Gu), 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.
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This document is a 510(k) premarket notification decision letter from the FDA to Nova Biomedical Corporation for their Stat Profile Critical Care Xpress (CCX 1+) System. It grants market clearance for the device based on substantial equivalence to existing predicate devices.
The document does not contain details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any other information requested in your prompt. This type of FDA letter confirms regulatory clearance but does not typically include the technical study results.
Therefore, I cannot fulfill your request using the provided text. To answer your questions, I would need access to the actual 510(k) submission document or a summary thereof, which would contain the performance data and study details.
§ 862.1110 Bilirubin (total or direct) test system.
(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.