# K053110: Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge

- Pathway: 510(k) (Special)
- Applicant: I-Stat Corporation
- Decided: Jan 13, 2006 after 70 days
- Product code: JGS (Electrode, Ion Specific, Sodium)
- Device class: 2
- Regulation: 21 CFR 862.1665
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) i-STAT CG8+ Cartridge: named in the summary without a submission number
- (no number) i-STAT EC9+ Cartridge: named in the summary without a submission number
- (no number) i-STAT CREA Cartridge: named in the summary without a submission number

## Most influential descendants
- K171247: epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test (2018), 1 descendant of its own
- K200107: epoc Blood Analysis System (2020), 0 descendants of its own

## Recalls of this device
- Apr 24, 2025 · Class II · Z-1846-2025: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the
- Feb 15, 2011 · Not classified · Z-2022-2011: i-STAT CHEM 8+ cartridge may generate false results for sodium, chloride and hematocrit.
- Feb 5, 2010 · Not classified · Z-1791-2010: Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.

## Indications for use
The i-STAT CHEM8+ Cartridge is useful for monitoring a variety of conditions. The panel of tests is used in the hospital environment to assess kidney function, electrolyte status, acid/base balance, and blood sugar level. This test panel is also used to assess hypertension and hypokalemia.

Source page: https://510kreport.com/device/K053110
Methodology: https://510kreport.com/methodology