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510(k) Data Aggregation
K Number
K183680Device Name
i-STAT CHEM8+ cartridge with the i-STAT 1 System
Manufacturer
Abbott Point of Care Inc.
Date Cleared
2020-02-28
(427 days)
Product Code
JPI
Regulation Number
864.6400Why did this record match?
Product Code :
JPI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The i-STAT CHEM8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of hematocrit in arterial or venous whole blood in point of care or clinical laboratory settings. Hematocrit measurements can aid in the determination and monitoring of normal total red cell volume status that can be associated with conditions including anemia and erythrocytosis. The i-STAT Hematocrit test has not been evaluated in neonates.
Device Description
The i-STAT CHEM8+ test cartridge contains test reagents to analyze whole blood at the point of care or in the clinical laboratory for hematocrit (HCT). The test is contained in a single-use, disposable cartridge. Cartridges require two to three drops of whole blood which are typically applied to the cartridge using a transfer device. 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 cartridge to move fluid across the sensors and generate a quantitative result (within approximately 2 minutes). The i-STAT 1 System is comprised of the i-STAT 1 analyzer, the i-STAT test cartridges and accessories (i-STAT 1 Downloader/Recharger, electronic simulator and portable printer). The system is designed for use by trained medical professionals at the patient point of care or in the clinical laboratory and is for prescription use only.
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K Number
K163342Device Name
i-STAT Hematocrit test with i-STAT Alinity System
Manufacturer
Abbott Laboratories
Date Cleared
2017-08-22
(266 days)
Product Code
JPI
Regulation Number
864.6400Why did this record match?
Product Code :
JPI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The i-STAT Alinity instrument with i-STAT tests is intended for use in point of care or clinical laboratory settings. The i-STAT Alinity system is intended for the quantitative measurement of various analytes in arterial and venous whole blood.
The i-STAT Hematocrit test is intended for use in the in vitro quantification of packed red blood cell volume fraction in arterial or venous heparinized whole blood, or in arterial or venous non-anticoagulated whole blood.
Hematocrit measurements can aid in the determination of normal or abnormal total red cell volume status that can be associated with conditions including anemia and erythrocytosis.
The i-STAT Hematocrit test with the i-STAT Alinity System has not been evaluated in neonates.
The i-STAT Hematocrit test with the i-STAT Alinity System is not for use with capillary samples.
For in vitro diagnostic use.
Device Description
The i-STAT Alinity System is a handheld, in vitro diagnostic analytical device designed to run i-STAT test cartridges. The system is designed for use at or near point of patient care, by trained medical professionals and is for prescription use only.
The i-STAT Alinity System is comprised of the instrument, rechargeable battery, base station, electronic simulator, control material, printer and i-STAT test cartridges. The i-STAT Alinity Instrument features a barcode scanner, user interface with touch screen display and wireless capability. The instrument reports quantitative results within approximately 2 minutes.
The i-STAT test cartridge contains sensors which are located on the biosensors chips. The instrument interacts with the cartridge to move fluid across the sensors and generate a quantitative result. Cartridges require two to three drops of whole blood which are typically applied to the cartridge using a syringe.
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