Product Code: LER FDA class 2 21 CFR 862.3880

Fluorescent Immunoassay, Theophylline

Clinical Toxicology

The Fluorescent Immunoassay for Theophylline is a laboratory diagnostic test used to quantitatively measure theophylline levels in patient specimens, supporting therapeutic drug monitoring for conditions such as asthma and chronic obstructive pulmonary disease. The device is FDA Class 2, indicating moderate risk; it requires 510(k) premarket notification to demonstrate substantial equivalence to a legally marketed predicate device. It carries product code LER and is regulated under 21 CFR 862.3880 in the Clinical Toxicology specialty. This device is eligible for third-party review under FDA's accredited persons program.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: LER
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

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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
K942192	THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS	Jul 13, 1994	Substantially Equivalent	SIGMA DIAGNOSTICS, INC.
K905521	CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION	Dec 26, 1990	Substantially Equivalent	MICROGENICS CORP.
K882570	TURBOX THEOPHYLLINE ASSAY	Nov 10, 1988	Substantially Equivalent	UNIPATH LTD.
K864409	IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS	Dec 22, 1986	Substantially Equivalent	SCLAVO, INC.
K863475	THEOFAST(TM) TEST PACKAGE	Nov 05, 1986	Substantially Equivalent	3M COMPANY
K842585	THEOPHYLLINE KIT FLUORESCENCE POLARIZA-	Sep 26, 1984	Substantially Equivalent	WINDSOR LABORATORIES, INC.
K840758	IMMPULSE THEOPHYLLINE ASSAY REAGENTS	Apr 04, 1984	Substantially Equivalent	PARAGON DIAGNOSTICS, INC.
K833070	TDX THEOPHYLLINE	Nov 14, 1983	Substantially Equivalent	ABBOTT LABORATORIES
K831514	AMWA TDA THEOPHYLLINE TEST	Jun 30, 1983	Substantially Equivalent	MILES LABORATORIES, INC.
K823576	COBAS STANDARD FOR TOTAL PROTEIN	Jan 07, 1983	Substantially Equivalent	HOFFMANN-LA ROCHE, INC.
K820397	AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM	Mar 02, 1982	Substantially Equivalent	AMERICAN DIAGNOSTIC CORP.
K813240	EMIT-AAD THEOPHYLLINE ASSAY	Dec 03, 1981	Substantially Equivalent	SYVA CO.
K812518	AMES TDA THEOPHYLLINE TEST	Sep 23, 1981	Substantially Equivalent	MILES LABORATORIES, INC.
K811856	FLUOROMATIC THEOPHYLLINE FIA	Jul 10, 1981	Substantially Equivalent	BIO-RAD
K810943	AMES TDA THEOPHYLLINE TEST	Apr 17, 1981	Substantially Equivalent	MILES LABORATORIES, INC.