# K112430: I-Stat Lactate Test/I-Sat CG4+Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Pont of Care, Inc.
- Decided: Dec 20, 2011 after 118 days
- Product code: KHP (Acid, Lactic, Enzymatic Method)
- Device class: 1
- Regulation: 21 CFR 862.1450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K982071 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982071: I-Stat Lactate Test, I-Stat Corp. (1998) Summary page 1.

## Indications for use
The Lactate Acid Test is indicated for (1) the diagnosis and treatment of lactic acidosis in conjunction with measurements of blood acidibase status, (2) monitoring tissue hypoxia and strenuous physical exertion, (3) diagnosis of hyperlactatemnia. The Lactate Test, as part of the i-STAT System, is intended for the in vitro measurement of lactate in arterial, venous, or capillary whole blood.

Source page: https://510kreport.com/device/K112430
Methodology: https://510kreport.com/methodology