Product Code: KLS FDA class 2 21 CFR 862.3880

Enzyme Immunoassay, Theophylline

Clinical Toxicology

The Theophylline Enzyme Immunoassay is an in vitro diagnostic test used in clinical toxicology laboratories to measure theophylline serum concentrations, supporting therapeutic drug monitoring for patients treated with this bronchodilator to optimize dosing and prevent toxicity. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket notification. The product code is KLS and the applicable regulation is 21 CFR 862.3880 in the Clinical Toxicology specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

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Basic Information

Product Code: KLS
Device Class: FDA class 2
Regulation Number: 862.3880
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 71 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K042520	VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III	Nov 30, 2004	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K042407	EMIT CAFFEINE ASSAY	Oct 28, 2004	Substantially Equivalent	Dade Behring, Inc.
K020740	ROCHE ONLINE THEOPHYLLINE	Apr 16, 2002	Substantially Equivalent	Roche Diagnostics Corp.
K011771	RANDOX THEOPHYLLINE	Jan 17, 2002	Substantially Equivalent	Randox Laboratories, Ltd.
K013272	ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY	Oct 25, 2001	Substantially Equivalent	Bayer Corp.
K011166	MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229	May 10, 2001	Substantially Equivalent	Syva Co., Dade Behring, Inc.
K993029	ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89	Jan 27, 2000	Substantially Equivalent	Syva Co.
K973583	ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS	Nov 12, 1997	Substantially Equivalent	Schiapparelli Biosystems, Inc.
K972495	ACCUMETER THEOPHYLLINE TEST	Oct 10, 1997	Substantially Equivalent	Chemtrak, Inc.
K961462	CEDIA THEOPHYLLINE ASSAY	Jun 27, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K954569	IMMULITE THEOPHYLLINE	Nov 13, 1995	Substantially Equivalent	Diagnostic Products Corp.
K952596	THEOPHYLLINE ENZYME IMMUNOASSAY	Aug 11, 1995	Substantially Equivalent	Diagnostic Reagents, Inc.
K943979	IL TEST THEOPHYLLINE	Jan 18, 1995	Substantially Equivalent	Instrumentation Laboratory CO
K935373	AXSYM THEOPHYLLINE	Jun 21, 1994	Substantially Equivalent	Abbott Laboratories
K932685	PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS	Sep 24, 1993	Substantially Equivalent	Baxter Diagnostics, Inc.
K933258	VIDAS THEOPHYLLINE(THEO)	Aug 16, 1993	Substantially Equivalent	Biomerieux Vitek, Inc.
K926245	ABBOTT VISION THEOPHYLLINE IIA	May 06, 1993	Substantially Equivalent	Abbott Laboratories
K913123	EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS	Sep 19, 1991	Substantially Equivalent	Syva Co.
K911060	IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM	May 08, 1991	Substantially Equivalent	Immunomatrix
K910697	IL THEOPHYLLINE ASSAY SYSTEM	Apr 03, 1991	Substantially Equivalent	Instrumentation Laboratory CO
K902243	TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES	Jul 05, 1990	Substantially Equivalent	Technicon Instruments Corp.
K901510	ENZYMATIC THEOPHYLLINE REAGENT, #500-82	Jun 12, 1990	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K900373	BIOTRACK THEOPHYLLINE TEST CARTRIDGE	May 30, 1990	Substantially Equivalent	Biotrack, Inc.
K900009	NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET	Mar 29, 1990	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K896927	VISION THEOPHYLLINE II	Jan 18, 1990	Substantially Equivalent	Abbott Laboratories
K885253	ACCULEVEL ONE-STEP THEOPHYLLINE TEST	Mar 31, 1989	Substantially Equivalent	Syva Co.
K884358	CEDIA THEOPHYLLINE ASSAY	Feb 07, 1989	Substantially Equivalent	Microgenics Corp.
K890002	COAT-A-COUNT (TM) THEOPHYLLINE	Jan 23, 1989	Substantially Equivalent	Diagnostic Products Corp.
K885044	BEHRING POLAROID OPUS THEOPHYLLINE	Dec 29, 1988	Substantially Equivalent	Pb Diagnostic Systems, Inc.
K884002	ANALYST THEOPHYLLINE ROTOR	Oct 31, 1988	Substantially Equivalent	The DU Pont Co.
K881257	EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT	May 27, 1988	Substantially Equivalent	Immunotech Corp.
K874578	EMIT CONVENIENCE PACK: THEOPHYLLINE ASSAY	Nov 24, 1987	Substantially Equivalent	Syva Co.
K873596	BAKER TDM THEOPHYLLINE ASSAY	Oct 20, 1987	Substantially Equivalent	Baker Instructions Corp.
K870736	DART THEOPHYLLINE REAGENT SYSTEM	Apr 14, 1987	Substantially Equivalent	Coulter Electronics, Inc.
K870952	THEOPHYLLINE FPIA REAGENT SET	Mar 31, 1987	Substantially Equivalent	Sigma Diagnostics, Inc.
K864041	EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95	Nov 25, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K862955	METHODS FOR THE DIMENSION CLINICAL CHEM. SYSTEM	Sep 25, 1986	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K862350	EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93	Jul 07, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K860464	VISION THEOPHYLLINE - ADDIT. OF WHOLE BLOOD CLAIM	Jun 17, 1986	Substantially Equivalent	Abbott Laboratories
K853872	EMIT CAFFEINE ASSAY	Jun 13, 1986	Substantially Equivalent	Syva Co.
K861367	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (THEO)	May 29, 1986	Substantially Equivalent	Eastman Kodak Company
K855227	MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL	Apr 11, 1986	Substantially Equivalent	Bioclinical Systems, Inc.
K854183	IN VITRO TEST DETERMINATION OF THEOPHYLLINE	Dec 19, 1985	Substantially Equivalent	Clinical Data, Inc.
K853858	IL TEST THEOPHYLLINE ASSAY	Oct 15, 1985	Substantially Equivalent	Allied Instrumentation Laboratory
K853834	VISION THEOPHYLLINE	Oct 15, 1985	Substantially Equivalent	Abbott Laboratories
K853372	GEMSTAR IPA THEOPHYLLINE TEST KIT	Sep 04, 1985	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.
K852573	TECHNICON RA-1000 SYSTEM ANALYTE THEOPHYLLINE	Jul 12, 1985	Substantially Equivalent	Technicon Instruments Corp.
K851741	ACCULEVEL THEOPHYLLINE TEST(MODIFICATION)	Jun 06, 1985	Substantially Equivalent	Syva Co.
K850856	ICS THEOPHYLLINE REAGENTS	Mar 29, 1985	Substantially Equivalent	Beckman Instruments, Inc.
K844642	ACCULEVEL THEOPHYLLINE TEST	Mar 19, 1985	Substantially Equivalent	Syva Co.
K844170	THEOPHYLLINE RADIOIMMUNOASSAY ARIA HT SYSTEM	Dec 11, 1984	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K841656	DUPONT THEOPHYLLINE ASSAY KIT	May 22, 1984	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K832825	SERALYZER THEOPHYLLINE REAGENT STRIPS	Mar 19, 1984	Substantially Equivalent	Miles Laboratories, Inc.
K833989	VENTREZYME THEOPHYLLINE IMMUNOASSAY	Jan 30, 1984	Substantially Equivalent	Vxr, Inc.
K834244	THEOFAST TEST KIT FOR QUANTITATIVE THEO	Jan 24, 1984	Substantially Equivalent	Allergenetics
K832965	STRATUS THEOPHYLLINE ASSAY	Dec 30, 1983	Substantially Equivalent	American Dade
K833683	CHEM KIT THEOPHYLLINE DIAG. KIT	Dec 27, 1983	Substantially Equivalent	Abbott Laboratories
K831934	THEOPHYLLINE TEST PACK ACA	Sep 12, 1983	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K832034	EMIT AAD THEOPHYLLINE ASSAY	Aug 01, 1983	Substantially Equivalent	Syva Co.
K831272	EMIT QST THEOPHYLLINE ASSAY	May 27, 1983	Substantially Equivalent	Syva Co.
K821544	DETECTION OF THEOPHYLLINE	Jun 10, 1982	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.
K821154	KALLESTAD QUANTIZYME THEOPHYLLINE ENZYME	May 13, 1982	Substantially Equivalent	Jay Rau, Technical Suppprt
K812003	A-GENT THEOPHYLLINE	Jul 27, 1981	Substantially Equivalent	Abbott Laboratories
K810578	BECKMAN THEOPHYLLINE REAGENT TEST KIT	Mar 13, 1981	Substantially Equivalent	Beckman Instruments, Inc.
K803094	COPPER SULFATE SOLUTION SP. GR.1.053	Mar 06, 1981	Substantially Equivalent	Accra Laboratories, Inc.
K802066	ENDAB THEOPHYLLINE ENZYME IMMUNOASSAY	Oct 23, 1980	Substantially Equivalent	Immunotech Corp.
K801642	FIAX TEST KIT FOR THEOPHYLLINE QUANT.	Aug 27, 1980	Substantially Equivalent	Intl. Diagnostic Technology
K801476	APPLICATION OF EMIT THEOPHYLLINE ASSAY	Jul 08, 1980	Substantially Equivalent	Syva Co.
K800646	AMES TDA THEOPHYL-LINE TEST	Apr 10, 1980	Substantially Equivalent	Miles Laboratories, Inc.
K790256	EMIT THEOPHYLLINE ASSAY	Mar 02, 1979	Substantially Equivalent	Syva Co.
K772017	IN VITRO THEOPHYLLINE RIA TEST	Mar 27, 1978	Substantially Equivalent	Clinical Assays, Inc.