← Product Code [DKZ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ) · K240670 # DRI Ecstasy Plus Assay (K240670) _Microgenics Corporation · DKZ · Oct 30, 2024 · Clinical Toxicology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ/K240670 ## Device Facts - **Applicant:** Microgenics Corporation - **Product Code:** [DKZ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ.md) - **Decision Date:** Oct 30, 2024 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 862.3100 - **Device Class:** Class 2 - **Review Panel:** Clinical Toxicology ## Indications for Use The DRI™ Ecstasy Plus Assay is an in vitro diagnostic medical device intended for the qualitative and semi-quantitative determination of MDMA (Ecstasy) in human urine. The assay is intended for use on automated clinical chemistry analyzers. The DRI™ Ecstasy Plus Assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) or liquid chromatography/tandem mass spectrometry (LC/MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. ## Device Story Homogeneous enzyme immunoassay for detection of ecstasy drugs (MDA, MDMA, MDEA) in human urine; utilizes mouse monoclonal anti-MDMA antibodies, glucose-6-phosphate (G6P), and nicotinamide adenine dinucleotide (NAD). Principle: competitive binding between drug in urine and drug-labeled glucose-6-phosphate dehydrogenase (G6PDH) enzyme conjugate for antibody binding sites; enzyme activity is proportional to drug concentration in sample. Used in clinical laboratories by trained professionals on automated analyzers (e.g., Abbott Architect C4000). Provides preliminary screening results; positive results require confirmation via GC/MS or LC-MS/MS. Assists clinicians in diagnosing ecstasy abuse by identifying presence of CNS stimulants; results interpreted alongside clinical observations and patient history. ## Clinical Evidence Bench testing only. Verification and validation activities performed to assess the impact of increased antibody loading. Design control documentation confirms the modified device performs equivalently to the predicate. ## Technological Characteristics Homogeneous enzyme immunoassay. Reagents: R1 (mouse monoclonal anti-MDMA antibody, G6P, NAD in Tris buffer with sodium azide); R2 (MDMA-labeled G6PDH enzyme conjugate in Tris buffer with sodium azide). Storage: 2-8°C. Analyzers: Automated clinical chemistry systems (e.g., Abbott Architect C4000). ## Regulatory Identification An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy. ## Special Controls *Classification.* Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military). ## Predicate Devices - DRI Ecstasy Enzyme Immunoassay ([K012110](/device/K012110.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION # SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ## I Background Information: A 510(k) Number K240670 B Applicant Microgenics Corporation C Proprietary and Established Names DRI™ Ecstasy Plus Assay D Regulatory Information | Product Code(s) | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | DKZ | Class II | 21 CFR 862.3100 - Amphetamine Test System | TX - Clinical Toxicology | ## II Review Summary: This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable. 1. The name and 510(k) number of the SUBMITTER'S previously cleared device. DRI Ecstasy Enzyme Immunoassay (K012110). 2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use). 3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov {1} demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. Changes, that is, increasing to the antibody loading for the use on a new instrument. 4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics. 5. A Design Control Activities Summary which includes: a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis. b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied. The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device. K240670 - Page 2 of 2 --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ/K240670](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ/K240670) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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