Thermo Scientific DRI Amphetamines Assay
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K093114 FDA 510(k)
- FDA Product Code
- DKZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3100 FDA 510(k)
- Regulation Number
- 862.3100 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Thermo Scientific DRI Amphetamines Assay is an enzyme immunoassay designed for the qualitative or semi-quantitative detection of amphetamine and methamphetamine in human urine. This immunoassay leverages enzymatic reactions to identify target analytes with high specificity, providing rapid results for clinical toxicology applications. It is classified as a Class II medical device under FDA regulations, ensuring compliance with stringent performance standards for diagnostic assays.
This assay is supplied as a ready-to-use liquid reagent, intended for use in clinical laboratories equipped with compatible analyzers. It is single-use and requires no additional preparation steps, simplifying workflows for toxicology testing. The assay features cutoff levels of 500 ng/mL for amphetamine and 1000 ng/mL for methamphetamine, with regulatory authorizations including FDA 510(k) clearance and IVDD compliance. Storage and handling follow standard laboratory protocols for immunoassay reagents, ensuring stability and reliability under controlled conditions.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Thermo Fisher Scientific - DE, DRI™ Amphetamine Drugs of Abuse Assays - Thermo Fisher Scientific, DE - Thermo Fisher Scientific, PDF DRI Amphetamines Assay - Thermo Fisher Scientific
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K093114 | Class II | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- FDA Applicant
- Microgenics Corp.
Sources (2)
- FDA 510(k) K093114 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026