Product Code: DAA FDA class 2 21 CFR 866.5510

Igg, Peroxidase, Antigen, Antiserum, Control

Immunology

This is an immunological reagent kit for the detection and quantification of immunoglobulin G (IgG) using a peroxidase-conjugated format, including antigen, antiserum, and control components for use in clinical immunology and pathology laboratories. IgG is the most abundant antibody class and plays a central role in secondary immune responses. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DAA, regulated under 21 CFR 866.5510, within the Immunology specialty.

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510(k)s

FEI Numbers

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Basic Information

Product Code: DAA
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 5 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K832675	ANA MICROZYME TEST SYS #1610	Sep 12, 1983	Substantially Equivalent	Clinical Sciences, Inc.
K831927	ANTINUCLEAR ANTIBODY TEST KIT	Jul 18, 1983	Substantially Equivalent	Breit Laboratories, Inc.
K830005	IP SPECIFIC G	Jun 02, 1983	Substantially Equivalent	Diagnostic Reagent Tech.
K822911	ANAZYME ANA PEROXIDASE TEST SYSTEM	Oct 22, 1982	Substantially Equivalent	Clinical Sciences, Inc.
K791749	INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL	Oct 17, 1979	Substantially Equivalent	Clinical Sciences, Inc.