# K051108: Piccolo Lactate Dephydrogenase Test System

- Pathway: 510(k) (Traditional)
- Applicant: Abaxis, Inc.
- Decided: Jul 8, 2005 after 67 days
- Product code: CFJ (Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase)
- Device class: 2
- Regulation: 21 CFR 862.1440
- 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 K011213 (2001). 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)
- K011213: Modification to Synchron LX 20 Clinical Chemistry System, Beckman Coulter, Inc. (2001) Summary page 1.

## Indications for use
The Piccolo Lactate Dehydrogenase Test System (presently contained on the Piccolo Basic Metabolic Panel Plus Reagent Disc) used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of lactate dehydrogenase activity in heparinized plasma or serum in a clinical laboratory setting or point-of-care location. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis and cirrhosis; cardiac diseases such as myocardial infarction; and tissue alterations of the heart, kidney, liver, and muscle.

Source page: https://510kreport.com/device/K051108
Methodology: https://510kreport.com/methodology