# K023640: Piccolo HDL Test System

- Pathway: 510(k) (Traditional)
- Applicant: Abaxis, Inc.
- Decided: Jan 24, 2003 after 86 days
- Product code: LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl)
- Device class: 1
- Regulation: 21 CFR 862.1475
- 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 K902935 (1990). 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)
- K902935: Roche Cobas Ready HDL Cholesterol Reagent, Roche Diagnostic Systems, Inc. (1990) Summary page 1.

## Most influential descendants
- K120662: Piccolo HDL-Capillary Test System (2012), 0 descendants of its own

## Indications for use
Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Source page: https://510kreport.com/device/K023640
Methodology: https://510kreport.com/methodology