LZI Methadone II Enzyme Immunoassay
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K192433 FDA 510(k)
- FDA Product Code
- DJR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3620 FDA 510(k)
- Regulation Number
- 862.3620 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The LZI Methadone II Enzyme Immunoassay is an in vitro diagnostic test intended for the qualitative and semi-quantitative determination of methadone in human urine at a cutoff value of 300 ng/mL. This homogeneous enzyme immunoassay is a ready-to-use liquid reagent that works based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent.
The assay is designed for prescription use with automated clinical chemistry analyzers. It is supplied as a liquid reagent and is intended for single-use. The device is FDA 510(k) cleared with K number K192433 and is classified as Class II under product code DJR for regulation 862.3620.
Frequently asked questions
What is the LZI Methadone II Enzyme Immunoassay used for?
The LZI Methadone II Enzyme Immunoassay is an in vitro diagnostic test designed for the qualitative and semi-quantitative determination of methadone in human urine at a cutoff value of 300 ng/mL. It is intended for prescription use with automated clinical chemistry analyzers.
How is the LZI Methadone II Enzyme Immunoassay supplied and is it reusable?
The assay is supplied as a ready-to-use liquid reagent and is specifically designed for single-use only. It should not be reused or stored for future testing once opened or used, as this could compromise the accuracy of the results.
What is the regulatory status of the LZI Methadone II Enzyme Immunoassay?
The device is FDA 510(k) cleared with K number K192433 and is classified as Class II under product code DJR for regulation 862.3620. It has been determined to be substantially equivalent to predicate devices for the intended use.
How does the LZI Methadone II Enzyme Immunoassay work?
This homogeneous enzyme immunoassay works based on competition between methadone in the patient sample and methadone labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. This competition produces a measurable signal that indicates the presence and quantity of methadone in the sample.
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: Products - Methadone II Enzyme Immunoassay - Lin-Zhi International, Inc., PDF LZI Methadone II Enzyme Immunoassay - lin-zhi.com, LZI Methadone II Enzyme Immunoassay (K192433) - Innolitics, PDF K192433 - LZI Methadone II Enzyme Immunoassay
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192433 | Class II | Active |
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Manufacturer
- Manufacturer
- Lin-Zhi International, Inc.
Sources (1)
- FDA 510(k) K192433 24 fields · synced Oct 6, 2026