Product Code: LAR FDA class 2 21 CFR 862.3320

Enzyme Immunoassay, Procainamide

Clinical Toxicology

Enzyme immunoassay for procainamide is a clinical toxicology test system used to quantify serum levels of procainamide, an antiarrhythmic drug with a narrow therapeutic index that requires routine monitoring. It is classified as FDA Class 2, requiring 510(k) premarket notification to demonstrate substantial equivalence. The product code is LAR, regulated under 21 CFR 862.3320, in 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: LAR
Device Class: FDA class 2
Regulation Number: 862.3320
Medical Specialty: Clinical Toxicology
Review Panel: TX
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 25 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K060773	ONLINE TDM PROCAINAMIDE	Aug 23, 2006	Substantially Equivalent	Roche Diagnostics Corp.
K032573	DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110	Oct 31, 2003	Substantially Equivalent	Dade Behring, Inc.
K010812	EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229	Apr 13, 2001	Substantially Equivalent	Syva Co., Dade Behring, Inc.
K971716	PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM	Jun 27, 1997	Substantially Equivalent	Bayer Corp.
K963306	CEDIA N-ACETYLPROCAINAMIDE ASSAY	Oct 29, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K962099	CEDIA PROCAINAMIDE ASSAY	Aug 27, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K962463	PROCAINAMIDE ENZYME IMMUNOASSAY	Aug 14, 1996	Substantially Equivalent	Diagnostic Reagents, Inc.
K955444	ABBOTT AXSM PROCAINAMIDE ASSAY	Apr 02, 1996	Substantially Equivalent	Abbott Laboratories
K951434	OPUS PROCAINAMIDE	Jul 03, 1995	Substantially Equivalent	Behring Diagnostics, Inc.
K942847	COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR	Dec 02, 1994	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K934762	OPUS PROCAINAMIDE TEST SYSTEM	Jul 20, 1994	Substantially Equivalent	Pb Diagnostic Systems, Inc.
K922914	EMIT 2000 PROCAINAMIDE CALIBRATORS	Aug 24, 1992	Substantially Equivalent	Syva Co.
K873350	EASY-TEST EMIT PROCAINAMIDE (PROC) #16648	Sep 29, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K860141	STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO.	Feb 11, 1986	Substantially Equivalent	American Dade
K852320	COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATOR	Jul 09, 1985	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K851061	EMIT QST PROCAINAMIDE ASSAY	Apr 12, 1985	Substantially Equivalent	Syva Co.
K834464	TDX PROCAINAMIDE	Feb 03, 1984	Substantially Equivalent	Abbott Laboratories
K833384	PROCAINAMIDE ANALYTICAL TEST PACK	Dec 27, 1983	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K832718	EMIT CAD PROCAINAMIDE ASSAY	Sep 12, 1983	Substantially Equivalent	Syva Co.
K831400	AMES TDA PROCAINAMIDE TEST	Jun 02, 1983	Substantially Equivalent	Miles Laboratories, Inc.
K823128	ADVANCE EMIT CAD PROCAINAMIDE ASSAY	Nov 29, 1982	Substantially Equivalent	Syva Co.
K811770	EMIT-CAD PROCAINAMIDE ASSAY	Jul 10, 1981	Substantially Equivalent	Syva Co.
K811034	EMIT-CAD N-ACETYLPROCAINAMIDE ASSAY	May 01, 1981	Substantially Equivalent	Syva Co.
K790403	EMIT QUINIDINE ASSAY	Mar 21, 1979	Substantially Equivalent	Syva Co.
K781382	EMIT PROCAINAMIDE ASSAY	Oct 17, 1978	Substantially Equivalent	Syva Co.