Accusign Doa 10, Accusign Doa 10 Panel, Acusign Met/Opi/Coc/Thc/Pcp/Bzo/Bar/Mtd…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K990786 FDA 510(k)
- FDA Product Code
- LAG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3610 FDA 510(k)
- Regulation Number
- 862.3610 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Accusign DOA 10 Panel is an immunoassay test kit for qualitative screening of drugs of abuse. It processes human samples to detect specific drug metabolites including methamphetamine, opiates, cocaine metabolites, THC metabolites, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, and methadone based on defined cut-off concentrations.
The device is supplied as a test kit and is intended for use in clinical toxicology settings. It received FDA 510(k) clearance (K990786) as a substantially equivalent device under product code LAG, with special clearance type, and is classified as a Class II medical device for high pressure liquid chromatography applications in drug screening.
Frequently asked questions
What is the Accusign DOA 10 Panel used for?
The Accusign DOA 10 Panel is used for qualitative screening of drugs of abuse in human samples. It detects specific drug metabolites including methamphetamine, opiates, cocaine metabolites, THC metabolites, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, and methadone based on defined cut-off concentrations, making it suitable for clinical toxicology settings where initial drug screening is needed.
How is the Accusign DOA 10 Panel supplied and what type of device is it?
The device is supplied as a test kit intended for use in clinical toxicology settings. It is an immunoassay test kit designed for qualitative screening, meaning it provides a positive or negative result for each drug class based on whether metabolite concentrations exceed predefined cut-off levels, rather than quantitative measurements.
What regulatory pathway was used for the Accusign DOA 10 Panel and what is its classification?
The Accusign DOA 10 Panel received FDA 510(k) clearance (K990786) as a substantially equivalent device under product code LAG. It is classified as a Class II medical device, with the clearance type designated as special, and is associated with high pressure liquid chromatography applications in drug screening according to its regulatory filing.
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: Accusign Doa 10, Accusign Doa 10 Panel, Acusign Met/Opi/Coc/Thc/Pcp/Bzo ..., Accusign Doa 10,Accusign Doa Panel,Accusign Met/Opi/Coc/Thc/Pcp/Bzo/Bar ..., Accusign Doa 10, Accusign Doa 10 Panel, Acusign Met/opi/coc/thc/pcp/bzo ..., Accusign Doa 10,Accusign Doa Panel,Accusign Met/Opi/Coc/Thc/Pcp/Bzo/Bar ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K990786 | Class II | Active |
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Manufacturer
- Manufacturer
- Princeton Biomeditech Corp.
Sources (1)
- FDA 510(k) K990786 24 fields · synced Sep 21, 2026