MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K162395 FDA 510(k)
- FDA Product Code
- DIO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3250 FDA 510(k)
- Regulation Number
- 862.3250 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MP DOA-10 Panel Test Cup and MP DOA-11 Panel Test Cup are immunochromatographic in-vitro devices designed for the qualitative detection of drug substances in human urine. The MP DOA-10 detects up to ten substances, while the MP DOA-11 detects up to eleven, including amphetamine, barbiturate, benzodiazepine, and cocaine metabolites, among others, at specified cut-off levels.
These devices are intended for single-use in clinical toxicology settings and require no special storage conditions beyond those specified by the manufacturer. Both models are classified as Class II devices under FDA regulation 862.3250 and have received FDA 510(k) clearance (K162395) as substantially equivalent to a predicate device. They are supplied as ready-to-use test cups for point-of-care or laboratory use.
Frequently asked questions
What substances does the MP DOA-11 Panel Test Cup detect, and how does it differ from the MP DOA-10?
The MP DOA-11 Panel Test Cup detects up to eleven substances, including amphetamine, barbiturate, benzodiazepine, and cocaine metabolites, among others. It differs from the MP DOA-10 by detecting one additional substance, as the MP DOA-10 detects up to ten substances. Both are immunochromatographic devices designed for qualitative detection of drug substances in human urine.
Are the MP DOA-10 and MP DOA-11 test cups intended for reuse, or are they single-use only?
The MP DOA-10 and MP DOA-11 Panel Test Cups are explicitly designed for single-use only in clinical toxicology settings. They are supplied as ready-to-use devices, meaning each test cup is intended for one-time use and should not be reused.
What storage conditions are required for the MP DOA-10 and MP DOA-11 Panel Test Cups?
No special storage conditions are required beyond those specified by the manufacturer. The devices are supplied as ready-to-use test cups, so they can be stored under standard conditions until use, as long as the manufacturer’s guidelines are followed.
How are these test cups supplied, and where can they be used?
The MP DOA-10 and MP DOA-11 Panel Test Cups are supplied as ready-to-use test cups for point-of-care or laboratory use. They are designed for clinical toxicology settings and can be used in environments where rapid, on-site testing of human urine for drug substances is required.
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: MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup, MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup 510 (k) K162395 ..., MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup - BEUDAMED
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162395 | Class II | Active |
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Manufacturer
- Manufacturer
- Mp Biomedicals, Llc
Sources (1)
- FDA 510(k) K162395 24 fields · synced Sep 19, 2026