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Last synced on 18 April 2025 at 11:05 pm
IM/
subpart-f—immunological-test-systems/
PCG
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21-Hydroxylase Antibody (21-Ohab)

Page Type
Product Code
Definition
For semi-quantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The assay may be useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency.
Physical State
RIA Assay Kit with reagents, antigen with I-125, calibrators, controls and assay buffer.
Technical Method
RIA
Target Area
None
Regulation Medical Specialty
Immunology
Review Panel
Immunology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
866.5660
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 § 866.5660 Multiple autoantibodies immunological test system

§ 866.5660 Multiple autoantibodies immunological test system.

(a) Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

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

FDA Browser

by Innolitics

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

21-Hydroxylase Antibody (21-Ohab)

Page Type
Product Code
Definition
For semi-quantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The assay may be useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency.
Physical State
RIA Assay Kit with reagents, antigen with I-125, calibrators, controls and assay buffer.
Technical Method
RIA
Target Area
None
Regulation Medical Specialty
Immunology
Review Panel
Immunology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
866.5660
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible
View Source

CFR § 866.5660 Multiple autoantibodies immunological test system

§ 866.5660 Multiple autoantibodies immunological test system.

(a) Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

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