EMIT Assay and Tobramycin
by Syva Co. 510(k)
Active
510(k) K832055
Overview
The EMIT Assay and Tobramycin is an enzymatic radiochemical assay device intended for the quantitative measurement of tobramycin concentrations in plasma and serum. Tobramycin is an aminoglycoside antibiotic, and this assay facilitates clinical toxicology monitoring by providing accurate drug level assessments to guide therapeutic management and avoid toxicity.
This device is supplied as a test system for use in clinical laboratories and is regulated under FDA 510(k) clearance (K832055) with a product code of LDO. It falls under the classification of Enzymatic Radiochemical Assay for Tobramycin, adhering to 21 CFR 862.3900. The system is intended for single-use applications in controlled laboratory settings, with no indication of MRI compatibility or reusable components. Storage and handling must comply with standard radiochemical assay protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK832055 | Date8 Aug 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LDO
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3900
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Syva Co.
Questions
What clinical purpose does the EMIT Assay and Tobramycin serve in patient care?
The EMIT Assay and Tobramycin is designed for quantitative measurement of tobramycin levels in plasma and serum. This helps clinicians monitor drug concentrations to ensure effective treatment while minimizing the risk of toxicity, which is critical for managing aminoglycoside antibiotic therapy.
Is this device intended for use outside of a clinical laboratory setting?
No, the EMIT Assay and Tobramycin is explicitly supplied as a test system for use only in clinical laboratories. Its design and regulatory classification (FDA 510(k)) reflect its intended controlled environment, where radiochemical assays are properly handled and monitored.
How is the EMIT Assay and Tobramycin supplied, and is it reusable?
The device is supplied as a single-use test system for clinical laboratories. It is not designed for reuse, and its components are not intended to withstand repeated applications. This aligns with standard radiochemical assay protocols to ensure accuracy and safety.
What regulatory pathway was followed for this device’s clearance?
The EMIT Assay and Tobramycin received FDA 510(k) clearance under the traditional review pathway, with a decision code of SESE (Substantially Equivalent). It was filed under product code LDO (Laboratory Devices, Other) and falls under 21 CFR 862.3900, reflecting its classification as an enzymatic radiochemical assay for tobramycin.
Are there any special storage or handling requirements for this assay?
While the data does not specify exact storage conditions, as a radiochemical assay, it must comply with standard protocols for handling radioactive materials in clinical laboratories. This includes proper shielding, containment, and adherence to institutional radiochemical safety guidelines to ensure safe use and disposal.