Identifiers
- 510(k) Number
- K912143 FDA 510(k)
- FDA Product Code
- LFW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3900 FDA 510(k)
- Regulation Number
- 862.3900 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Fluorescence Polarization Immunoassay for Tobramycin, as defined in the device type and openFDA data. It is a homogeneous enzyme immunoassay system that uses recombinant DNA technology to produce genetically engineered fragments of the bacterial enzyme beta-galactosidase for the detection of tobramycin.
The assay is supplied as a diagnostic test for in vitro use, cleared via FDA 510(k) under K912143, and classified as a Class II device with product code LFW. It is intended for use in clinical toxicology settings and was cleared on July 26, 1991, following a traditional 510(k) review.
Frequently asked questions
What is the CEDIA Tobramycin Assay used for?
The CEDIA Tobramycin Assay is used for the in vitro detection of tobramycin in clinical toxicology settings, utilizing fluorescence polarization immunoassay technology to measure drug levels in patient samples.
How is the CEDIA Tobramycin Assay supplied and what technology does it use?
The assay is supplied as a diagnostic test for in vitro use and employs a homogeneous enzyme immunoassay system based on recombinant DNA technology, using genetically engineered beta-galactosidase fragments to detect tobramycin via fluorescence polarization.
What regulatory pathway was used for the CEDIA Tobramycin Assay and when was it cleared?
The device was cleared via the FDA 510(k) pathway under submission K912143 on July 26, 1991, following a traditional review, and is classified as a Class II device with product code LFW.
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: CEDIA(R) TOBRAMYCIN ASSAY (K912143) — FDA 510(k) | Innolitics, K912143 FDA 510(k) - CEDIA TOBRAMYCIN ASSAY | Microgenics Corp., PDF CEDIATM Tobramycin II Assay - Thermo Fisher Scientific
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K912143 | Class II | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- FDA Applicant
- Microgenics Corp.
Sources (1)
- FDA 510(k) K912143 24 fields · synced Sep 21, 2026