LGQ · Fluorescence Polarization Immunoassay, Phenobarbital
Clinical Toxicology · 21 CFR 862.3660 · Class 2
Overview
| Product Code | LGQ |
|---|---|
| Device Name | Fluorescence Polarization Immunoassay, Phenobarbital |
| Regulation | 21 CFR 862.3660 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A phenobarbitol test system is a device intended to measure phenobarbital, an antiepileptic and sedative-hypnotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to ensure appropriate therapy.
Classification Rationale
Class II.
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K972331 | INNOFLUOR GENTAMICIN ASSAY SYSTEM | Oxis Intl., Inc. | Aug 1, 1997 | SESE |
| K972330 | INNOFLUOR PHENOBARBITAL ASSAY SYSTEM | Oxis Intl., Inc. | Jul 14, 1997 | SESE |
| K940596 | AXSYM PHENOBARBITAL | Abbott Laboratories | Jun 21, 1994 | SESE |
| K936130 | COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS | Roche Diagnostic Systems, Inc. | Mar 11, 1994 | SESE |
| K900704 | MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA | Innotron of Oregon, Inc. | Apr 12, 1990 | SESE |
| K894525 | FPR PHENOBARBITAL KIT | Colony Laboratories, Inc. | Aug 28, 1989 | SESE |
| K872397 | COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI. | Roche Diagnostic Systems, Inc. | Jul 21, 1987 | SESE |
| K863625 | PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT | Windsor Laboratories, Inc. | Nov 10, 1986 | SESE |
| K862528 | IMMPULSE PHENOBARBITAL ASSAY REAGENTS | Sclavo, Inc. | Jul 16, 1986 | SESE |
| K854044 | TDX BARBITURATES | Abbott Laboratories | Oct 28, 1985 | SESE |
| K843825 | COBAS REAGENTS PHENOBARBITAL & PHENOBAR | Roche Diagnostic Systems, Inc. | Feb 1, 1985 | SESE |
| K841707 | INNOFLUOR PHENOBARBITAL | Innotron Diagnostics | May 23, 1984 | SESE |
Top Applicants
- Roche Diagnostic Systems, Inc. — 3 clearances
- Abbott Laboratories — 2 clearances
- Oxis Intl., Inc. — 2 clearances
- Colony Laboratories, Inc. — 1 clearance
- Innotron Diagnostics — 1 clearance
