Identifiers
- 510(k) Number
- K032279 FDA 510(k)
- FDA Product Code
- KLP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3035 FDA 510(k)
- Regulation Number
- 862.3035 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Online TDM Amika is an Amikacin serum assay used for the quantitative determination of Amikacin in human serum or plasma. This device is designed to assist in the monitoring of therapeutic drug levels within a clinical setting.
This device is supplied by Roche Diagnostics Corp. and has received FDA 510K clearance. It is classified as a class 2 medical device under regulation number 862.3035.
Frequently asked questions
What is the primary clinical purpose of the Online TDM Amika?
The Online TDM Amika is an Amikacin serum assay used for the quantitative determination of Amikacin in human serum or plasma. It is specifically designed to assist clinicians in monitoring therapeutic drug levels within a clinical setting.
What is the regulatory status of this device?
The Online TDM Amika has received FDA 510K clearance under K-number K032279. It is classified as a class 2 medical device under regulation number 862.3035, which pertains to clinical toxicology.
Who is the manufacturer of the Online TDM Amika?
This device is manufactured and supplied by Roche Diagnostics Corp., located in Indianapolis, Indiana. The company manages the distribution and regulatory compliance for this assay.
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 | K032279 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA 510(k) K032279 24 fields · synced Sep 23, 2026