# K130113: Piccolo Lactate Test System

- Pathway: 510(k) (Traditional)
- Applicant: Abaxis, Inc.
- Decided: Mar 11, 2013 after 54 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
Lactate measurements are used in the diagnosis and treatment of lactate acidosis, monitoring tissue hypoxia, and diagnosis of hyperlactatemia.

Source page: https://510kreport.com/device/K130113
Methodology: https://510kreport.com/methodology