Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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013
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Date of Entry 11/08/2005
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FR Recognition Number
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7-113
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Standard | |
CLSI I/LA23-A (Replaces I/LA23-P) Assessing the Quality of Immunoassay Systems: Radioimmunoassays, and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline |
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Scope/AbstractThis guideline addresses components for harmonizing and assessing the quality of immunoassay systems for several commonly used dose-response indicator categories, e.g., radioisotopes, enzymes, fluorescence, luminescence, reagents, and experimental components criteria essential to characterizing an immunoassay. |
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Extent of Recognition
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§866.5510 |
Radioimmunoassay, Immunoglobulins (G, A, M)
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Class 2
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CFQ
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§866.5510 |
Igd, Antigen, Antiserum, Control
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Class 2
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CZJ
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§866.5510 |
Iga, Peroxidase, Antigen, Antiserum, Control
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Class 2
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CZL
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§866.5510 |
Iga, Antigen, Antiserum, Control
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Class 2
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CZP
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§866.5510 |
Igg, Peroxidase, Antigen, Antiserum, Control
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Class 2
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DAA
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§866.5510 |
Igg, Antigen, Antiserum, Control
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Class 2
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DEW
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§866.5510 |
Igg (Gamma Chain Specific), Antigen, Antiserum, Control
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Class 2
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DFZ
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§866.5510 |
Igd, Peroxidase, Antigen, Antiserum, Control
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Class 2
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DGH
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§866.5510 |
Ige, Peroxidase, Antigen, Antiserum, Control
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Class 2
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DGO
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§866.5510 |
Radioimmunoassay, Immunoglobulins (D, E)
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Class 2
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JHR
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§866.5520 |
Fab, Antigen, Antiserum, Control
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Class 1
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DCE
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§866.5520 |
Igg (Fab Fragment Specific), Antigen, Antiserum, Control
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Class 1
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DFK
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§866.5530 |
Igg (Fc Fragment Specific), Antigen, Antiserum, Control
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Class 1
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DAS
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§866.5530 |
Fc, Antigen, Antiserum, Control
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Class 1
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DBN
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§866.5530 |
Reagent, Immunoassay, Igg
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Class 1
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KTO
|
§866.5540 |
Igg (Fd Fragment Specific), Antigen, Antiserum, Control
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Class 1
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DAQ
|
§866.5550 |
Igm (Mu Chain Specific), Antigen, Antiserum, Control
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Class 2
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DAO
|
§866.5550 |
Lambda, Antigen, Antiserum, Control
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Class 2
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DEH
|
§866.5550 |
Lambda, Peroxidase, Antigen, Antiserum, Control
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Class 2
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DEP
|
§866.5550 |
Igm, Peroxidase, Antigen, Antiserum, Control
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Class 2
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DEY
|
§866.5550 |
Kappa, Peroxidase, Antigen, Antiserum, Control
|
Class 2
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DFD
|
§866.5550 |
Kappa, Antigen, Antiserum, Control
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Class 2
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DFH
|
§866.5550 |
Igm, Antigen, Antiserum, Control
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Class 2
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DFT
|
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Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |
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