Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone Calibrators, Lzi O…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K120763 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 LZI Oxycodone Homogeneous Enzyme Immunoassay is an enzyme immunoassay for opiates, classified under device class 2, intended for the qualitative and semi-quantitative determination of oxycodone in human urine at cutoff values of 100 ng/mL and 300 ng/mL. It is designed for prescription use with automated clinical chemistry analyzers and is substantially equivalent to a legally marketed device as determined by FDA 510(k) clearance K120763.
The device includes calibrators and controls as part of the assay system and is manufactured by Lin-Zhi International, Inc. It is regulated under regulation number 862.3650 and falls within the medical specialty of Clinical Toxicology. The product is supplied for in vitro diagnostic use and is not indicated as sterile, single-use, reusable, or MRI-safe in the provided data.
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 LZI Oxycodone Enzyme Immunoassay - Lin-Zhi, PDF LZI Oral Fluid Oxycodone Enzyme Immunoassay - lin-zhi.com, Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120763 | Class II | Active |
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Manufacturer
- Manufacturer
- Lin-Zhi International, Inc.
Sources (1)
- FDA 510(k) K120763 24 fields · synced Oct 6, 2026