LDO · Enzymatic Radiochemical Assay, Tobramycin
Clinical Toxicology · 21 CFR 862.3900 · Class 2
Overview
| Product Code | LDO |
|---|---|
| Device Name | Enzymatic Radiochemical Assay, Tobramycin |
| Regulation | 21 CFR 862.3900 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A tobramycin test system is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.
Classification Rationale
Class II.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K043384 | VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND III | Ortho-Clinical Diagnostics, Inc. | Feb 7, 2005 | SESE |
| K841556 | HEART - AID ALS, 95 | Cardiac Resucitator Corp. | Jul 19, 1984 | SESE |
| K832055 | EMIT ASSAY AND TOBRAMYCIN | Syva Co. | Aug 8, 1983 | SESE |
Top Applicants
- Cardiac Resucitator Corp. — 1 clearance
- Ortho-Clinical Diagnostics, Inc. — 1 clearance
- Syva Co. — 1 clearance
