# K163342: i-STAT Hematocrit test with i-STAT Alinity System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Aug 22, 2017 after 266 days
- Product code: JPI (Device, Hematocrit Measuring)
- Device class: 2
- Regulation: 21 CFR 864.6400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K001387 (2000). 2 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103195: I-Stat 1 Wireless Analyzer, Abbott Point of Care, Inc. (2011) Summary page 4.

## Most influential descendants
- K183680: i-STAT CHEM8+ cartridge with the i-STAT 1 System (2020), 4 descendants of its own
- K210958: i-STAT CHEM8+ cartridge with the i-STAT 1 System (2021), 3 descendants of its own
- K223755: i-STAT G cartridge with the i-STAT 1 System (2023), 1 descendant of its own
- K252488: ABL90 FLEX PLUS System (2026), 0 descendants of its own
- K223710: i-STAT CG8+ cartridge with the i-STAT 1 System (2023), 0 descendants of its own

## Indications for 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 and monitoring 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.

Source page: https://510kreport.com/device/K163342
Methodology: https://510kreport.com/methodology