Cedia Dau Multi-Level Thc Assay, Hitachi 911 Reagent/ And The Hitachi 747 Reage…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K940649 FDA 510(k)
- FDA Product Code
- LDJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3870 FDA 510(k)
- Regulation Number
- 862.3870 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CEDIA DAU Multi-Level THC Assay is an enzyme immunoassay (EIA) designed for the quantitative detection of tetrahydrocannabinol (THC) and its metabolites in biological specimens. This device leverages chemiluminescent enzyme immunoassay technology to measure multiple levels of THC, enabling clinical toxicology assessments for drug monitoring and forensic analysis.
This assay is supplied as a reagent kit for use with the Hitachi 911 or 747 automated analyzers, requiring no additional preparation beyond standard laboratory procedures. The reagents are intended for single-use in a regulated clinical toxicology setting, with compliance to FDA 510(k) clearance (K940649) and IVDD standards. Storage and handling follow standard in vitro diagnostic device protocols, ensuring accuracy and reliability for clinical use.
Frequently asked questions
What types of biological specimens can the CEDIA DAU Multi-Level THC Assay detect THC and its metabolites in, and how is it used in clinical settings?
The CEDIA DAU Multi-Level THC Assay is designed for quantitative detection of tetrahydrocannabinol (THC) and its metabolites in biological specimens, though the exact specimen types (e.g., urine, blood, saliva) are not specified in the data. It uses chemiluminescent enzyme immunoassay (EIA) technology on the Hitachi 911 or 747 automated analyzers for clinical toxicology assessments. This means it is primarily used for drug monitoring and forensic analysis in regulated laboratory settings, where precise measurement of THC levels is critical for medical or legal purposes.
Is this assay intended for single-use or repeated use, and how should the reagents be stored?
The CEDIA DAU Multi-Level THC Assay reagents are explicitly intended for single-use in a clinical toxicology setting, as stated in the device description. Storage and handling follow standard in vitro diagnostic device protocols, which typically require refrigeration (e.g., 2–8°C) and protection from light until use. Always refer to the manufacturer’s instructions for precise storage guidelines to maintain accuracy and reliability.
What automated analyzers are compatible with this assay, and are there any special preparation requirements beyond standard lab procedures?
The assay is supplied as a reagent kit specifically for use with the Hitachi 911 or Hitachi 747 automated analyzers. No additional preparation beyond standard laboratory procedures is required, meaning it integrates seamlessly into existing workflows for these systems. This compatibility ensures consistency in testing for clinical toxicology applications.
What regulatory pathways has this device undergone, and how does that affect its use in clinical toxicology?
The CEDIA DAU Multi-Level THC Assay has undergone FDA 510(k) clearance (K940649) and compliance with In Vitro Diagnostic Device Directive (IVDD) standards, confirming its safety, performance, and equivalence to existing devices in the category. This regulatory route ensures the assay meets stringent clinical toxicology requirements, validating its use for accurate THC detection in regulated settings.
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: Cedia Dau Multi-level Thc Assay, Hitachi 911 Reagent/ and The Hitachi ..., fda.innolitics.com, PDF CEDIATM Multi-Level THC Assay - Thermo Fisher Scientific, K935591 FDA 510(k) - CEDIA DAU MULTI-LEVEL THC ASSAY
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 | K940649 | Class II | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- FDA Applicant
- Microgenics Corp.
Sources (2)
- FDA 510(k) K940649 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026