# K012855: Liquispx Liquid Lipid Control

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Controls Division
- Decided: Aug 30, 2001 after 6 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Clinical Controls LiquiSPx Liquid Lipid control is a ready-to-use, assayed chemistry control material for monitoring the accuracy and precision of lipid assays. It is suitable for use with both manual and automated analytical procedures. Lipid analysis consists of measuring total cholesterol, triglycerides, HDL and LDL cholesterol. It is used to assist in the diagnosis and management of lipoprotein disorders in normal and at risk patient populations.

Source page: https://510kreport.com/device/K012855
Methodology: https://510kreport.com/methodology