# K191360: i-STAT CHEM8+ cartridge with the i-STAT 1 System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Point of Care, Inc.
- Decided: Feb 14, 2020 after 269 days
- Product code: JFP (Electrode, Ion Specific, Calcium)
- Device class: 2
- Regulation: 21 CFR 862.1145
- 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; 2 cite 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)
- K061597: Epoc Blood Analysis System, Epocal, Inc. (2006) Summary page 4.

## Most influential descendants
- 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
- K230300: i-STAT CG8+ cartridge with the i-STAT 1 System (2023), 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 CHEM8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of ionized calcium in arterial or venous whole blood in point of care or clinical laboratory settings. Ionized calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.

Source page: https://510kreport.com/device/K191360
Methodology: https://510kreport.com/methodology