Product Code: DGO FDA class 2 21 CFR 866.5510

Ige, Peroxidase, Antigen, Antiserum, Control

Immunology

The IgE Peroxidase Antigen, Antiserum, and Control is a peroxidase-conjugated immunological reagent used in enzyme-based immunoassays such as ELISA to detect and quantify IgE immunoglobulins, which are central mediators of allergic responses. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 866.5510 within the Immunology specialty. The device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

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Basic Information

Product Code: DGO
Device Class: FDA class 2
Regulation Number: 866.5510
Medical Specialty: Immunology
Review Panel: PA
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
K943194	IMMULITE(R) ALLERGY FOOD PANEL FP5E	Feb 23, 1995	Substantially Equivalent	Diagnostic Products Corp.
K920087	IGE EIA TEST KIT	Sep 14, 1992	Substantially Equivalent	The Binding Site, Ltd.
K911511	ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED	Apr 17, 1991	Substantially Equivalent	Diagnostic Products Corp.
K894039	QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION	Jul 14, 1989	Substantially Equivalent	Quidel Corp.
K893125	BECKMAN EPSILON(TM) IGE REAGENT KIT	Jun 16, 1989	Substantially Equivalent	Beckman Instruments, Inc.
K872801	ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5	Sep 10, 1987	Substantially Equivalent	Diagnostic Products Corp.
K860851	ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM	Mar 28, 1986	Substantially Equivalent	Nichols Institute Diagnostics
K853607	ALLERG-E IGE ENZYME IMMUNOASSAY KIT	Nov 07, 1985	Substantially Equivalent	Dexall Biomedical Labs, Inc.
K831984	POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE	Nov 21, 1983	Substantially Equivalent	Diagnostic Reagent Tech.
K831987	EPSILON IGE TEST KIT	Oct 14, 1983	Substantially Equivalent	Beckman Instruments, Inc.
K831774	LOGIPE A DATA REDUCSYSTEM IP SPECIFIC-	Jul 18, 1983	Substantially Equivalent	Diagnostic Reagent Tech.
K830653	POLYSTYRENE MICROTITER PLATE IMMUNOSORB	Apr 08, 1983	Substantially Equivalent	Diagnostic Reagent Tech.
K830495	POLYSTYRENE MICROTITER PLATE IMMUNOSOR	Apr 05, 1983	Substantially Equivalent	Diagnostic Reagent Tech.
K821094	IP SPECIFIC E	May 07, 1982	Substantially Equivalent	Diagnostic Reagent Tech.
K800995	IMMUNOGLOBULIN E TEST KIT	May 14, 1980	Substantially Equivalent	Calbiochem-Behring Corp.