# K040918: Wako Lipid Control, Level 1 and Level 2

- Pathway: 510(k) (Traditional)
- Applicant: Wako Chemicals USA, Inc.
- Decided: May 17, 2004 after 39 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Feb 5, 2010 · Not classified · Z-1792-2010: Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.

## Indications for use
The Wako Quality Control is intended for use as an assay quality control serum to monitor the precision of laboratory testing procedures for the Wako lipid assay such as Triglycerides, HDL-Cholesterol, LDL-Cholesterol, Total Cholesterol, Phospholipids, Apolipoproteins, NEFA C, Free Cholesterol and beta Lipoprotein assays.

Source page: https://510kreport.com/device/K040918
Methodology: https://510kreport.com/methodology