| 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
|
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
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
