# K972819: Vigil TDM Controls

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Aug 13, 1997 after 15 days
- Product code: DIF (Drug Mixture Control Materials)
- Device class: 1
- Regulation: 21 CFR 862.3280
- Recalls of this device: none
- 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.
No later device cites it as a predicate yet.
0 of 2 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)

## Indications for use
The Beckman Vigil Therapeutic Drug Monitoring (TDM) Controls are designed for monitoring the reliability and overall performance of Beckman Therapeutic Drug test systems in the clinical laboratory. The use of three levels of control allows the laboratorian to monitor change in calibration along with analytical error and imprecision.

Source page: https://510kreport.com/device/K972819
Methodology: https://510kreport.com/methodology