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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 020 Date of Recognition 09/09/2008 
FR Recognition Number 7-136
CLSI I/LA2-A2 (Replaces I/LA2-A)
Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Flurescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods; Approved Guideline - Second Edition.
The elements of this guideline include: 1) a development plan for an effective analysis and evaluation; 2) a discussion of the planning and design considerations that are necessary for a successful evaluation; 3) a description of requirements for conducting the evaluation through monitoring and database management; and 4) a brief review of the analytical performance measures that must be in place before testing clinical specimens.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§866.5100 Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls Class 2 LJM
§866.5100 Antinuclear Antibody, Antigen, Control Class 2 LKJ
§866.5100 Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control Class 2 DHN
§866.5100 Extractable Antinuclear Antibody, Antigen And Control Class 2 LLL
Relevant FDA Guidance and/or Supportive Publications
Guidance for Industry and FDA Staff Recommendations for Anti-Nuclear Antibody (ANA) Test System Premarket (510(k)) Submissions, Issued January 2009.
FDA Technical Contacts
 Carolina Kagan
 Elizabeth Stafford
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics