Product Code: LGQ FDA class 2 21 CFR 862.3660

Fluorescence Polarization Immunoassay, Phenobarbital

Clinical Toxicology

A fluorescence polarization immunoassay for phenobarbital is a laboratory test that uses polarized light-based immunoassay technology to measure phenobarbital concentrations in patient specimens, used for therapeutic drug monitoring in patients receiving this anticonvulsant for seizure disorders. The device is FDA Class 2, representing moderate risk and requiring 510(k) premarket clearance. It carries product code LGQ and is regulated under 21 CFR 862.3660 within the Clinical Toxicology specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LGQ
Device Class: FDA class 2
Regulation Number: 862.3660
Medical Specialty: Clinical Toxicology
Review Panel: TX
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 12 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K972331	INNOFLUOR GENTAMICIN ASSAY SYSTEM	Aug 01, 1997	Substantially Equivalent	Oxis Intl., Inc.
K972330	INNOFLUOR PHENOBARBITAL ASSAY SYSTEM	Jul 14, 1997	Substantially Equivalent	Oxis Intl., Inc.
K940596	AXSYM PHENOBARBITAL	Jun 21, 1994	Substantially Equivalent	Abbott Laboratories
K936130	COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS	Mar 11, 1994	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K900704	MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA	Apr 12, 1990	Substantially Equivalent	Innotron of Oregon, Inc.
K894525	FPR PHENOBARBITAL KIT	Aug 28, 1989	Substantially Equivalent	Colony Laboratories, Inc.
K872397	COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI.	Jul 21, 1987	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K863625	PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT	Nov 10, 1986	Substantially Equivalent	Windsor Laboratories, Inc.
K862528	IMMPULSE PHENOBARBITAL ASSAY REAGENTS	Jul 16, 1986	Substantially Equivalent	Sclavo, Inc.
K854044	TDX BARBITURATES	Oct 28, 1985	Substantially Equivalent	Abbott Laboratories
K843825	COBAS REAGENTS PHENOBARBITAL & PHENOBAR	Feb 01, 1985	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K841707	INNOFLUOR PHENOBARBITAL	May 23, 1984	Substantially Equivalent	Innotron Diagnostics