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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 020 Date of Entry 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, Indirect Immunofluorescent, Antigen, Control Class 2 DHN
§866.5100 Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls Class 2 LJM
§866.5100 Antinuclear Antibody, Antigen, Control Class 2 LKJ
§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.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Elizabeth Stafford
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
*These are provided as examples and others may be applicable.