DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K150502 FDA 510(k)
- FDA Product Code
- DJG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3650 FDA 510(k)
- Regulation Number
- 862.3650 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The DRI Hydrocodone Assay, Calibrators, and Controls are enzyme immunoassay kits designed for the qualitative detection of hydrocodone and its metabolites in biological specimens. These devices utilize a homogeneous assay format to provide rapid, liquid-based testing for clinical toxicology applications, enabling accurate identification of hydrocodone presence in drug screening programs.
Supplied as liquid, ready-to-use reagents, these components are intended for single-use in laboratory settings. The assay, calibrators, and controls are regulated under FDA 510(k) clearance and In Vitro Diagnostic Device Directive (IVDD) compliance, with no third-party distribution. Storage and handling follow standard in vitro diagnostic protocols, ensuring stability and reliability for clinical toxicology testing. The kits are categorized under device class II and are assigned registration numbers for regulatory tracking.
Frequently asked questions
What is the primary use of the DRI Hydrocodone Assay, Calibrators, and Controls in a clinical setting?
The DRI Hydrocodone Assay, Calibrators, and Controls are designed for qualitative detection of hydrocodone and its metabolites in biological specimens, such as urine or blood. They are specifically intended for clinical toxicology applications, including drug screening programs to identify the presence of hydrocodone in patient samples. The homogeneous enzyme immunoassay format allows for rapid, liquid-based testing in laboratory settings.
Are these kits meant for single-use or repeated use in a laboratory?
These kits are explicitly intended for single-use only. The DRI Hydrocodone Assay, Calibrators, and Controls are supplied as ready-to-use liquid reagents, which means they are not designed to be reused after opening or initial use. This ensures accuracy and reliability for each test run in clinical toxicology applications.
How should the DRI Hydrocodone Assay, Calibrators, and Controls be stored to maintain their integrity?
Storage follows standard in vitro diagnostic protocols to ensure stability and reliability. While the exact storage conditions (e.g., temperature, duration) are not detailed in the provided data, typical enzyme immunoassay kits like these are generally stored at refrigerated temperatures (2–8°C) until use. Always refer to the manufacturer’s instructions for precise storage guidelines, as improper handling could compromise test accuracy.
What regulatory pathways have been followed for this device, and how does that affect its use?
The DRI Hydrocodone Assay, Calibrators, and Controls have undergone FDA 510(k) clearance and comply with the In Vitro Diagnostic Device Directive (IVDD). This means they are classified as Class II medical devices, which requires premarket review to ensure safety and effectiveness. The kits are not distributed through third-party channels, meaning they are sold directly by Microgenics Corporation. Clinicians and laboratories can rely on this regulatory clearance for confidence in their use for hydrocodone detection.
What types of biological specimens can be tested using these kits, and what is the expected format of the assay?
The kits are designed for qualitative detection in biological specimens, though the exact specimen types (e.g., urine, serum, whole blood) are not specified beyond
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: PDF DRITM Hydrocodone Assay - Thermo Fisher Scientific, DRI™ Hydrocodone Drugs of Abuse Calibrators, DRI™ Hydrocodone Calibrator, 300 ng/mL, 1 x 10 mL, DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone ...
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 | K150502 | Class II | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
Sources (2)
- FDA 510(k) K150502 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026