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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 021 Date of Entry 03/18/2009 
FR Recognition Number 7-170
Standard
CLSI I/LA21-A2
Clinical Evaluation of Immunoassays; Approved Guideline - Second Edition
Scope/Abstract
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)*
ALL PRODUCT CODES IN CLINICAL CHEMISTRY, TOXICOLOGY, HEMATOLOGY, IMMUNOLOGY, MICROBIOLOGY, PATHOLOGY
Relevant FDA Guidance and/or Supportive Publications*
Points to Consider for Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) Clearance, Issued September 1994.

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
 Shyam Kalavar
  FDA/OC/CDRH/OPEQ/OIDRH/DMGP/MPCB/
  301-796-6807
  shyam.kalavar@fda.hhs.gov
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.
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