# K982071: I-Stat Lactate Test

- Pathway: 510(k) (Traditional)
- Applicant: I-Stat Corp.
- Decided: Jun 29, 1998 after 17 days
- Product code: KHP (Acid, Lactic, Enzymatic Method)
- Device class: 1
- Regulation: 21 CFR 862.1450
- Recalls of this device: 1 (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; 2 cite 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) Stat Profile® Plus Ultra/Lactic acid test: named in the summary without a submission number

## Most influential descendants
- K130113: Piccolo Lactate Test System (2013), 0 descendants of its own
- K112430: I-Stat Lactate Test/I-Sat CG4+Cartridge (2011), 0 descendants of its own

## Recalls of this device
- Aug 21, 2025 · Class II · Z-2582-2025: Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2.

## Indications for use
The i-STAT lactate test is useful for (1) the diagnosis and treatment of lactic acidosis in conjunction with measurements of blood acid/base status, (2) monitoring tissue hypoxia and strenuous physical exertion, and (3) diagnosis of hyperlactatemia.

Source page: https://510kreport.com/device/K982071
Methodology: https://510kreport.com/methodology