# K980853: Cedia Dau Multi-Drug Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Apr 21, 1998 after 47 days
- Product code: DKB (Calibrators, Drug Mixture)
- 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices 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) Methadone Metabolite Urine Calibrators: named in the summary without a submission number

## Most influential descendants
- K081378: Dri Methadone Metabolite (100/300) Assay, Calibrators and Controls (2009), 1 descendant of its own
- K101752: Thermo Scientific Cedia Multi-Drug Oft Calibrators (2011), 0 descendants of its own
- K092048: One Step Eddp (Methadone Metabolite) Test Strip (2010), 0 descendants of its own

## Indications for use
The CEDIA® DAU Multi-Drug Calibrators are intended for the calibration of qualitative and semiquantitative CEDIA DAU Assays on automated clinical chemistry analyzers.

Source page: https://510kreport.com/device/K980853
Methodology: https://510kreport.com/methodology