# K052826: QMS Quinidine.  QMS Quinidine Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Seradyn, Inc.
- Decided: Dec 23, 2005 after 79 days
- Product code: LBZ (Enzyme Immunoassay, Quinidine)
- Device class: 2
- Regulation: 21 CFR 862.3320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Abbott TDx/TDxFLx Quinidine: named in the summary without a submission number

## Indications for use
The QMS® Quinidine assay is intended for the quantitative determination of quinidine in human serum or plasma on automated clinical chemistry analyzers. The results obtained are used in the diagnosis and treatment of quinidine overdose and in monitoring levels of quinidine to help ensure appropriate therapy.

Source page: https://510kreport.com/device/K052826
Methodology: https://510kreport.com/methodology