# K974452: Vigil Lipid Control

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Dec 17, 1997 after 22 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- 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
Longest line of descent: 1 generation back to K936184 (1994). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K936184: Vigil PRX Chemistry Control, Beckman-Diagnostic Systems Group (1994) Summary page 1.

## Most influential descendants
- K983640: Synchron Systems Lipid Calibrator (1998), 1 descendant of its own
- K042195: Synchron Systems HDL Cholesterol (HDL), Synchron Systems Lipid Plus Calibrators 1 & 2, Models A15625/A16747 (2004), 0 descendants of its own
- K020521: Modification to Vigil Lipid Control (2002), 0 descendants of its own

## Recalls of this device
- Jul 30, 2004 · Not classified · Z-1101-04: Results of tests are biased low due to a vendor change in formulation not brought to the attention of the recalling firm.

## Indications for use
Beckman’s Vigil Lipid Control is intended for use in monitoring the reliability of automated in vitro diagnostic assays of total cholesterol, HDL cholesterol (HDLc), triglycerides, apolipoprotein A-1 and apolipoprotein B in the clinical laboratory. The use of three or more levels of control allows the laboratorian to monitor change in calibration linearity along with analytical error and imprecision.

Source page: https://510kreport.com/device/K974452
Methodology: https://510kreport.com/methodology