LEH · Radioimmunoassay, Vancomycin
Clinical Toxicology · 21 CFR 862.3950 · Class 2
Overview
| Product Code | LEH |
|---|---|
| Device Name | Radioimmunoassay, Vancomycin |
| Regulation | 21 CFR 862.3950 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 31)
Showing 20 most recent of 31 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K222439 | Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) | Siemens Healthcare Diagnostics, Inc. | Aug 8, 2023 | SESE |
| K160202 | Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) | Siemens Healthcare Diagnostics, Inc. | Apr 27, 2016 | SESE |
| K152245 | ONLINE TDM Vancomycin Gen.3 | Roche Diagnostics Operations (Rdo) | Jan 8, 2016 | SESE |
| K123947 | ARCHITECT IVANCOMYCIN | Biokit, S.A. | Aug 29, 2013 | SESE |
| K072036 | ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01 | Biokit, S.A. | Mar 19, 2008 | SESE |
| K063045 | IMMULITE 2000, IMMULITE 2500 VANCOMYCIN | Diagnostic Products Corp. | Dec 5, 2006 | SESE |
| K060586 | ENZYME IMMUNOASSAY, VANCOMYCIN | Roche Diagnostics Corp. | May 11, 2006 | SESE |
| K050419 | QMS VANCOMYCIN | Seradyn, Inc. | Apr 1, 2005 | SESE |
| K043386 | VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III | Ortho-Clinical Diagnostics, Inc. | Feb 7, 2005 | SESE |
| K032811 | CEDIA VANCOMYCIN ASSAY | Microgenics Corp. | Nov 24, 2003 | SESE |
| K020692 | EMIT 2000 VANCOMYCIN ASSAY | Dade Behring, Inc. | May 10, 2002 | SESE |
| K013076 | SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR | Beckman Coulter, Inc. | Dec 12, 2001 | SESE |
| K983280 | VANCOMYCIN EIA ASSAY | Diagnostic Reagents, Inc. | Nov 6, 1998 | SESE |
| K964587 | VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM | Bayer Corp. | Jan 13, 1997 | SESE |
| K963267 | VANCOMYCIN FLEX REAGENT CARTRIDGE | Dade Intl., Inc. | Sep 13, 1996 | SESE |
| K955851 | AXSYM VANCOMYCIN II | Abbott Laboratories | May 9, 1996 | SESE |
| K955716 | VANCOMYCIN FPIA REAGENT SET | Sigma Diagnostics, Inc. | Feb 16, 1996 | SESE |
| K953528 | ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN | Roche Diagnostic Systems, Inc. | Sep 12, 1995 | SESE |
| K951059 | CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY | Ciba Corning Diagnostics Corp. | Jun 19, 1995 | SESE |
| K945125 | DUPONT ACA VANCOMYCIN (VANC) METHOD | The DU Pont Co. | Mar 10, 1995 | SESE |
Top Applicants
- Abbott Laboratories — 4 clearances
- Biokit, S.A. — 2 clearances
- Innotron of Oregon, Inc. — 2 clearances
- Roche Diagnostic Systems, Inc. — 2 clearances
- Siemens Healthcare Diagnostics, Inc. — 2 clearances
