# K120664: Piccolo Trglycerides-Capillary Test System

- Pathway: 510(k) (Traditional)
- Applicant: Abaxis, Inc.
- Decided: Apr 24, 2012 after 50 days
- Product code: JGY (Colorimetric Method, Triglycerides)
- Device class: 1
- Regulation: 21 CFR 862.1705
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K854152 (1985). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023639: Piccolo Triglycerides Test System, Abaxis, Inc. (2003) Summary page 1.
- K893973: Roche Reagent for Triglycerides, Roche Diagnostic Systems, Inc. (1989) Summary page 1.

## Indications for use
The Piccolo Triglycerides - Capillary Test System used with the Piccolo xpress Chemistry Analyzer is intended for the in vitro quantitative determination of triglycerides in capillary (fingerstick) heparinized whole blood in a clinical laboratory setting or point-of-care location. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism, or various endocrine disorders.

Source page: https://510kreport.com/device/K120664
Methodology: https://510kreport.com/methodology