Product Code: CFQ FDA class 2 21 CFR 866.5510

Radioimmunoassay, Immunoglobulins (G, A, M)

Immunology

The Radioimmunoassay, Immunoglobulins (G, A, M) test system (product code CFQ) is an in-vitro diagnostic device used in immunology laboratories to quantify immunoglobulin classes IgG, IgA, and IgM in serum using a radioimmunoassay method. It is classified as FDA Class 2, representing moderate risk, and requires a 510(k) premarket notification prior to marketing. It falls under regulation 21 CFR 866.5510 in the Immunology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: CFQ
Device Class: FDA class 2
Regulation Number: 866.5510
Medical Specialty: Immunology
Review Panel: IM
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 12 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K981786	IGA MININEPH ANTISERUM	Nov 24, 1999	Substantially Equivalent	The Binding Site, Ltd.
K990552	IMMUNOGLOBULIN A TEST SYSTEM	Mar 25, 1999	Substantially Equivalent	Dade Behring, Inc.
K990551	IGG FLEX REAGENT CARTRIDGE	Mar 25, 1999	Substantially Equivalent	Dade Behring, Inc.
K990553	IGM FLEX REAGENT CARTRIDGE	Mar 22, 1999	Substantially Equivalent	Dade Behring, Inc.
K951055	OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENT	Apr 17, 1995	Substantially Equivalent	Olympus America, Inc.
K951013	OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENT	Apr 17, 1995	Substantially Equivalent	Olympus America, Inc.
K950900	OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT	Mar 27, 1995	Substantially Equivalent	Olympus America, Inc.
K891188	TITAN GEL IFE TRIVALENT ANTISERUM	Mar 22, 1989	Substantially Equivalent	Helena Laboratories
K890561	SPQ(TM) ANTIBODY REAGENT SET II FOR IGM	Feb 23, 1989	Substantially Equivalent	Atlantic Antibodies
K881928	MONOCLONAL RADIAL IMMUNODIFFUSION KIT	Jul 08, 1988	Substantially Equivalent	The Binding Site, Ltd.
K881827	IMMUNOGLOBULIN A TEST SYSTEM	Jun 10, 1988	Substantially Equivalent	The Binding Site, Ltd.
K881828	IMMUNOGLOBULIN M TEST SYSTEM	Jun 06, 1988	Substantially Equivalent	The Binding Site, Ltd.