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Last synced on 18 April 2025 at 11:05 pm
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subpart-f—immunological-test-systems/
OBE
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Anti-Ss-A 52 Autoantibodies

Page Type
Product Code
Definition
The device is used for the detection, in human serum or plasma, of autoantibodies to SS-A 52. The detection of SS-A 52 autoantibodies may aid in the diagnosis of systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, polymyositis and dermatomyositis.
Physical State
The device consist of components/reagents to detect and semi-quantitatively measure autoantibodies to SS-A 52.
Technical Method
Enzyme-linked immunosorbent assay (ELISA) or enzyme immunoassay (EIA)
Target Area
The assay is performed by testing human serum or plasma.
Regulation Medical Specialty
Immunology
Review Panel
Immunology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
866.5100
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible
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CFR § 866.5100 Antinuclear antibody immunological test system

§ 866.5100 Antinuclear antibody immunological test system.

(a) Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).

(b) Classification. Class II (performance standards).

FDA Browser

by Innolitics

IM/
subpart-f—immunological-test-systems/
OBE
View Source

Anti-Ss-A 52 Autoantibodies

Page Type
Product Code
Definition
The device is used for the detection, in human serum or plasma, of autoantibodies to SS-A 52. The detection of SS-A 52 autoantibodies may aid in the diagnosis of systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, polymyositis and dermatomyositis.
Physical State
The device consist of components/reagents to detect and semi-quantitatively measure autoantibodies to SS-A 52.
Technical Method
Enzyme-linked immunosorbent assay (ELISA) or enzyme immunoassay (EIA)
Target Area
The assay is performed by testing human serum or plasma.
Regulation Medical Specialty
Immunology
Review Panel
Immunology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
866.5100
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible
View Source

CFR § 866.5100 Antinuclear antibody immunological test system

§ 866.5100 Antinuclear antibody immunological test system.

(a) Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).

(b) Classification. Class II (performance standards).