(266 days)
The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of ionized calcium and hematocrit in arterial or venous whole blood in point of care or clinical laboratory settings.
The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of hematocrit in capillary whole blood in point of care or clinical laboratory settings.
Ionized calcium measurements are used in the diagnosis, monitoring, and treatment of conditions including, but not limited to, parathyroid disease, a variety of bone disease, chronic renal disease, tetany, and disturbances related to surgical and intensive care.
Hematocrit measurements can aid in the determination of normal or abnormal total red cell volume status that can be associated with conditions including anemia, erythrocytosis, and blood loss related to trauma and surgery.
The i-STAT CG8+ cartridge is used with the i-STAT 1 analyzer as part of the i-STAT 1 System and contains test reagents to measure hematocrit (Hct) in arterial, venous or capillary whole blood and to measure ionized calcium (iCa) in arterial and venous 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 CG8+ 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 CG8+ 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 movement occur within the i-STAT CG8+ cartridges require two to three drops of whole blood which are 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 instrument interacts with the i-STAT CG8+ cartridge to move fluid across the sensors and generate a quantitative result (within approximately 2 minutes).
The provided text describes the analytical performance studies for the i-STAT CG8+ cartridge with the i-STAT 1 System, a device for in vitro quantification of ionized calcium (iCa) and hematocrit (Hct). This submission sought to demonstrate substantial equivalence to a predicate device (i-STAT CHEM8+ cartridge with the i-STAT 1 System, K191360).
Here's an analysis of the acceptance criteria and study details based on the provided information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state pre-defined acceptance criteria (e.g., target ranges for precision, linearity, or bias). Instead, it presents the results of various analytical performance studies. The conclusion states that the studies demonstrate substantial equivalence to the predicate device, implying that the reported performance metrics met the internal or regulatory thresholds for such a claim.
However, we can infer performance targets for some aspects by comparing the reported results to general expectations for such devices or by looking at the predicate device's characteristics mentioned (though the predicate's detailed performance is not provided in this document).
For the purpose of this request, I will present the reported performance values. The "Acceptance Criteria" column will reflect the general expectation of "demonstrating substantial equivalence" or meeting regulatory standards for the tested parameter, as specific numerical acceptance criteria are not provided in the document.
| Test Parameter | Acceptance Criteria (Inferred from "Substantial Equivalence") | Reported Device Performance (i-STAT CG8+ cartridge with i-STAT 1 System) |
|---|---|---|
| Precision (Aqueous Materials) - 20 Days | Performance demonstrating substantial equivalence to predicate. | iCa (mmol/L): Overall Within-Laboratory SD typically |
§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.