# K040758: MGC Dau Control Sets: Primary, Clinical and Select

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: May 28, 2004 after 64 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 K951135 (1995). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951135: Multi-Drug Control Set, Microgenics Corp. (1995) Summary page 1.

## Most influential descendants
- K081378: Dri Methadone Metabolite (100/300) Assay, Calibrators and Controls (2009), 1 descendant of its own
- K103656: Thermo Scientific Mas R Doa Total (2011), 0 descendants of its own
- K092048: One Step Eddp (Methadone Metabolite) Test Strip (2010), 0 descendants of its own

## Indications for use
The MGC DAU Control Set consists of controls intended for use in the validation of drug of abuse assays performed using human urine.

Source page: https://510kreport.com/device/K040758
Methodology: https://510kreport.com/methodology