LFW · Fluorescence Polarization Immunoassay, Tobramycin
Clinical Toxicology · 21 CFR 862.3900 · Class 2
Overview
| Product Code | LFW |
|---|---|
| Device Name | Fluorescence Polarization Immunoassay, 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 (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K964670 | ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN | Roche Diagnostic Systems, Inc. | Feb 4, 1997 | SESE |
| K944371 | TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR | Sigma Diagnostics, Inc. | Nov 10, 1994 | SESE |
| K941614 | AXSYM TOBRAMYCIN | Abbott Laboratories | Aug 18, 1994 | SESE |
| K912143 | CEDIA(R) TOBRAMYCIN ASSAY | Microgenics Corp. | Jul 26, 1991 | SESE |
| K900707 | MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR | Innotron of Oregon, Inc. | Apr 20, 1990 | SESE |
| K894531 | FPR TOBRAMYCIN KIT | Colony Laboratories, Inc. | Sep 1, 1989 | SESE |
| K872562 | INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET | Innotron of Oregon, Inc. | Aug 17, 1987 | SESE |
| K854392 | TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMU | Windsor Laboratories, Inc. | Dec 5, 1985 | SESE |
| K843828 | COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA | Roche Diagnostic Systems, Inc. | Feb 1, 1985 | SESE |
| K841866 | INNOFLOUR TOBRAMYCIN | Innotron Diagnostics | May 31, 1984 | SESE |
Top Applicants
- Innotron of Oregon, Inc. — 2 clearances
- Roche Diagnostic Systems, Inc. — 2 clearances
- Abbott Laboratories — 1 clearance
- Colony Laboratories, Inc. — 1 clearance
- Innotron Diagnostics — 1 clearance
