# K973292: I-Stat System

- Pathway: 510(k) (Traditional)
- Applicant: I-Stat Corp.
- Decided: Oct 20, 1997 after 48 days
- Product code: CGL (Electrode, Ion Based, Enzymatic, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

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

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K051968: ABL8X7 Flex (2006), 0 descendants of its own

## Recalls of this device
- Mar 17, 2010 · Not classified · Z-0456-2011: The i-STAT CREA Cartridges may produce inaccurate (depressed) results at or near the end of the labeled expiry date when stored above 25 degrees for 2 weeks.
- Oct 18, 2007 · Not classified · Z-0373-2008: Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.

## Indications for use
For the quantitative determination of Creatinine (Crea) in whole blood with the i-STAT analyzer. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Source page: https://510kreport.com/device/K973292
Methodology: https://510kreport.com/methodology