# K130200: Piccolo Total Cholesterol - Capillary Test System

- Pathway: 510(k) (Traditional)
- Applicant: Abaxis, Inc.
- Decided: Feb 15, 2013 after 18 days
- Product code: CHH (Enzymatic Esterase--Oxidase, Cholesterol)
- Device class: 1
- Regulation: 21 CFR 862.1175
- 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 K952127 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031824: Cobas Integra Cholesterol Gen. 2, Roche Diagnostics Corp. (2003) Summary page 1.

## Indications for use
The Piccolo Total Cholesterol - Capillary Test System used with the Piccolo xpress Chemistry Analyzer is intended for the in vitro quantitative determination of total cholesterol in capillary (fingerstick) heparinized whole blood in a clinical laboratory setting or point-of-care location. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein disorders.

Source page: https://510kreport.com/device/K130200
Methodology: https://510kreport.com/methodology