# K012109: Dri Ecstasy Urine Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: Aug 27, 2001 after 52 days
- Product code: DLJ (Calibrators, Drug Specific)
- 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 K983159 (1998). 1 ancestor in all.
8 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983159: Drugs of Abuse Urine Calibrators and Controls, Diagnostic Reagents, Inc. (1998) Summary page 1.

## Most influential descendants
- 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
- K150275: Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls (2015), 0 descendants of its own

## Indications for use
The DRI® Ecstasy Urine Calibrators are intended for the calibration of the DRI Ecstasy Immunoassay.

Source page: https://510kreport.com/device/K012109
Methodology: https://510kreport.com/methodology