Product Code: LGR FDA class 2 21 CFR 862.3350

Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)

Clinical Toxicology

A fluorescence polarization immunoassay measuring total diphenylhydantoin (phenytoin) is a laboratory test used to determine the total (bound plus free) serum concentration of the anticonvulsant drug diphenylhydantoin, supporting therapeutic drug monitoring in patients with epilepsy. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It bears product code LGR and is regulated under 21 CFR 862.3350 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

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Basic Information

Product Code: LGR
Device Class: FDA class 2
Regulation Number: 862.3350
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 15 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K955873	ACS PHENYTOIN ASSAY	Mar 11, 1996	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K955562	INNOFLUOR PHENYTOIN ASSAY SYSTEM	Jan 24, 1996	Substantially Equivalent	Oxis Intl., Inc.
K953840	AXSYM PHENYTOIN II	Sep 25, 1995	Substantially Equivalent	Abbott Laboratories
K946328	TDX(R)/TDXFLX(R) PHENYTOIN II	Mar 28, 1995	Substantially Equivalent	Abbott Laboratories
K943313	PHENYTOIN FPIA REAGENT SET AND CALIBRATORS	Oct 27, 1994	Substantially Equivalent	Sigma Diagnostics, Inc.
K935375	AXSYM PHENYTOIN ASSAY	Jun 21, 1994	Substantially Equivalent	Abbott Laboratories
K936131	COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS	Mar 11, 1994	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K896868	OPUS PHENYTOIN TEST SYSTEM	Jan 02, 1990	Substantially Equivalent	Pb Diagnostic Systems, Inc.
K895827	INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET	Oct 31, 1989	Substantially Equivalent	Innotron of Oregon, Inc.
K872563	INNOTRON INNOFLUOR PHEYTOIN REAGENT SET	Aug 21, 1987	Substantially Equivalent	Innotron of Oregon, Inc.
K862554	IMMPULSE PHENYTOIN ASSAY REAGENT	Jul 16, 1986	Substantially Equivalent	Sclavo, Inc.
K843824	COBAS FP REAGENTS FOR PHENYTOIN & CALIBR	Feb 01, 1985	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K844171	PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE	Dec 10, 1984	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K842586	PHENYTOIN KIT FLUORESCENCE POLARIZATION	Sep 26, 1984	Substantially Equivalent	Windsor Laboratories, Inc.
K841706	INNOFLUOR PHENYTOIN	May 22, 1984	Substantially Equivalent	Innotron Diagnostics