# K091617: QMS Lidocaine Calibrators, Model 0374678

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Fisher Scientific
- Decided: Jul 17, 2009 after 44 days
- Product code: DLJ (Calibrators, Drug Specific)
- Device class: 2
- Regulation: 21 CFR 862.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K842280 (1984). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031856: Preciset TDM I and Preciset TDM II Calibrators, Roche Diagnostics Corp. (2003) Summary page 1.

## Indications for use
The QMS Lidocaine Calibrator set is intended for use in calibration of the QMS Lidocaine assay.

Source page: https://510kreport.com/device/K091617
Methodology: https://510kreport.com/methodology