(266 days)
The i-STAT G3+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of pH, partial pressure of oxygen (PO2), and partial pressure of carbon dioxide (PCO2) in arterial, venous, or capillary whole blood in point of care or clinical laboratory settings.
pH, PO2, and PCO2 measurements are used in the diagnosis, monitoring, and treatment of respiratory, metabolic, and acid-base disturbances.
The i-STAT G3+ cartridge is used with the i-STAT 1 analyzer as part of the i-STAT 1 Sustem to measure pH, partial pressure of oxygen (PO2), and partial pressure of carbon dioxide (PCO2) in arterial, venous or capillary whole blood.
The i-STAT 1 System is an in vitro diagnostic (IVD) medical device intended for the quantitative determination of various clinical chemistry tests contained within i-STAT cartridges using whole blood. The i-STAT 1 System consists of a portable blood analyzer (i-STAT 1 analyzer), single-use disposable test cartridges (i-STAT cartridges), liquid quality control and calibration verification materials, and accessories (i-STAT 1 Downloader/Recharger, i-STAT Electronic Simulator and i-STAT 1 Printer). The i-STAT 1 System, including the i-STAT G3+ cartridge, is designed for use by trained medical professionals in point of care or clinical laboratory settings and is for prescription use only.
The i-STAT G3+ cartridge contains the required sensors, a fluid pack (calibrant pouch), a sample entry well and closure, fluid channels, waste chamber, and the necessary mechanical features for controlled fluid movement within cartridge. The i-STAT cartridge format allows all the tests in the cartridge to be performed simultaneously. All the test steps and fluid movements occur within the -STAT G3+ cartridge. The i-STAT 1 analyzer interacts with the i-STAT G3+ cartridge to move fluid across the sensors and generate a quantitative result. Cartridges require two to three drops of whole blood applied to the cartridge using a transfer device by the trained user before the cartridge is placed within the analyzer.
The i-STAT 1 analyzer is a handheld, in vitro diagnostic analytical device designed to run only i-STAT test cartridges. The analyzer interacts with the cartridge to move fluid across the sensors and generate a quantitative result (within approximately 2 minutes).
Here's a breakdown of the acceptance criteria and the studies that demonstrate the Abbott i-STAT G3+ cartridge with the i-STAT 1 System meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as a separate table within the document. However, they are implied by the performance characteristics demonstrated in the analytical and comparison studies. The performance reported in these studies indicates the criteria that the device successfully met for precision, linearity, detection limits, analytical specificity (interference), altitude stability, and method comparison.
Based on the provided text, the device's performance is demonstrated against these implied criteria.
| Category | Specific Metric / Test | Acceptance Criteria (Implied by achieved performance) | Reported Device Performance |
|---|---|---|---|
| Analytical Performance | |||
| Precision (Aqueous) | Repeatability (SD) | Low SD/CV (e.g., pH |
§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.