# K936184: Vigil PRX Chemistry Control

- Pathway: 510(k) (Traditional)
- Applicant: Beckman-Diagnostic Systems Group
- Decided: Apr 15, 1994 after 109 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.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K974452: Vigil Lipid Control (1997), 3 descendants of its own
- 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
- K982224: Vigil Protein Control (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K936184
Methodology: https://510kreport.com/methodology