# K101752: Thermo Scientific Cedia Multi-Drug Oft Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: Apr 8, 2011 after 290 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
Longest line of descent: 1 generation back to K980853 (1998). 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)
- K980853: Cedia Dau Multi-Drug Calibrators, Boehringer Mannheim Corp. (1998) Summary page 1.

## Indications for use
The CEDIA® Multi-Drug OFT Calibrators are intended for use in the calibration of d-Amphetamine, Benzoylecgonine, Morphine and Phencyclidine (PCP) in human Oral Fluid when used with the CEDIA Amphetamine, Cocaine, Opiate, and Phencyclidline (PCP) OFT Assays on the MGC 240 analyzer. This in vitro diagnostic device is intended for clinical laboratory use only.

Source page: https://510kreport.com/device/K101752
Methodology: https://510kreport.com/methodology