# K010496: Cedia Dau Amphetamines/Ecstasy Assay

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: May 29, 2001 after 97 days
- Product code: LAF (Gas Chromatography, Methamphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3610
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012110: Dri Ecstasy Enzyme Immunoassay (2001), 9 descendants of its own
- K043028: Emit II Plus Ecstasy Assay (2005), 6 descendants of its own
- K053337: Dimension Urine Ecstasy Screen Flex Reagent Cartridge, Model DF 109 (2006), 2 descendants of its own
- K102779: Emit II PLUS6-Acetylmorphine Assay; Emit II Plus 6-AM/ Ecstasy Calibrator/ Control Level 1; Emit II Plus 6-AM / Ectasy C (2011), 1 descendant of its own
- K062128: The Dimension Vista Flex Reagent Cartridges / Kit Assays (2006), 1 descendant of its own

Source page: https://510kreport.com/device/K010496
Methodology: https://510kreport.com/methodology