# K023642: Piccolo Total Cholesterol Test System

- Pathway: 510(k) (Traditional)
- Applicant: Abaxis, Inc.
- Decided: Jan 24, 2003 after 86 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: 1 generation back to K802743 (1980). 1 ancestor in all.
1 later device descends from it; 1 cites 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)
- K802743: Ames Sera-Pak Cholesterol Reagent Kit, Miles Laboratories, Inc. (1980) Summary page 1.

## Most influential descendants
- K251091: Lipids (2025), 0 descendants of its own

## Indications for use
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/K023642
Methodology: https://510kreport.com/methodology