# K020521: Modification to Vigil Lipid Control

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Mar 1, 2002 after 10 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
Longest line of descent: 2 generations back to K936184 (1994). 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)
- K974452: Vigil Lipid Control, Beckman Instruments, Inc. (1997) Summary page 1.

## Indications for use
Vigil Lipid Control stabilized liquid-control serums are intended for monitoring the reliability of manual and automated in vitro diagnostic assays of lipid analytes. The values for this control have been established using Beckman Coulter Reagents on Beckman Coulter Clinical Analyzers, and are specific for those systems. The use of three or more levels of control enables the laboratorian to monitor changes in calibration linearity along with analytical error and imprecision.

Source page: https://510kreport.com/device/K020521
Methodology: https://510kreport.com/methodology