Identifiers
- 510(k) Number
- K951133 FDA 510(k)
- FDA Product Code
- JXN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3700 FDA 510(k)
- Regulation Number
- 862.3700 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CEDIA DAU Propoxyphene Assay is an enzyme immunoassay intended to quantitatively measure propoxyphene, a narcotic analgesic, in biological specimens such as serum, plasma, and urine. It employs a chemiluminescent enzyme donor-acceptor immunoassay (CEDIA) technology to detect and quantify propoxyphene levels, aiding in clinical toxicology assessments for overdose or therapeutic monitoring.
This assay is supplied as a diagnostic test kit for in vitro use in clinical laboratories. It is classified as a Class II device under FDA regulations (21 CFR 862.3700, Product Code JXN) and has received FDA 510(k) clearance (K951133) for substantial equivalence to a predicate device. The device is intended for single-use per the manufacturer’s specifications and requires adherence to standard laboratory protocols for handling, storage, and testing.
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 PROPOXYPHENE ASSAY (K951133) — FDA 510(k) | Innolitics, CEDIA DAU PROPOXYPHENE ASSAY (K951133) - FDA 510(k), PDF K951133 CEDIA DAU PROPOXYPHENE ASSAY - 510kdatabase.net, CEDIA DAU PROPOXYPHENE ASSAY 510(k) K951133 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K951133 | Class II | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- FDA Applicant
- Microgenics Corp.
Sources (1)
- FDA 510(k) K951133 24 fields · synced Sep 19, 2026