LZI Tramadol Enzyme Immunoassay
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K201223 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 Tramadol Enzyme Immunoassay is an enzyme immunoassay device used for the detection of tramadol and its metabolites in human urine. It is classified as a Class II medical device under the Clinical Toxicology specialty and is substantially equivalent to a legally marketed predicate device.
The device is intended for use in clinical laboratory settings to aid in the assessment of tramadol use. It is supplied as a reagent kit for in vitro diagnostic use and is not sterile, not intended for single-use or reusable classification in the traditional sense, and has no stated MRI safety information. Storage conditions and specific sizes are not detailed in the provided data. The device holds FDA 510(k) clearance under K201223 and is manufactured by Lin-Zhi International, Inc.
Frequently asked questions
What is the LZI Tramadol Enzyme Immunoassay used for?
The LZI Tramadol Enzyme Immunoassay is used for the detection of tramadol and its metabolites in human urine. It aids in the assessment of tramadol use in clinical laboratory settings as an in vitro diagnostic device.
How is the LZI Tramadol Enzyme Immunoassay supplied and is it sterile?
The device is supplied as a reagent kit for in vitro diagnostic use. It is not sterile, as no sterility claim is made in the provided data, and it is not intended for single-use or reusable classification in the traditional sense.
What regulatory clearance does the LZI Tramadol Enzyme Immunoassay have?
The device holds FDA 510(k) clearance under submission number K201223, which was received on May 6, 2020, and granted on June 4, 2020. It is classified as a Class II medical device under the Clinical Toxicology specialty.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201223 | Class II | Active |
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Manufacturer
- Manufacturer
- Lin-Zhi International, Inc.
Sources (1)
- FDA 510(k) K201223 24 fields · synced Oct 6, 2026