| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
021
|
Date of Entry 03/18/2009
|
|
FR Recognition Number
|
13-26
|
| Standard | |
CLSI AUTO10-A
Autoverification of Clinical Laboratory Test Results; Approved Guideline |
|
Scope/Abstract| This document provides a general framework that will allow each laboratory to easily design, implement, validate, and customize rules for autoverification (automated verification) based on the needs of its own patient population. |
|
| Extent of Recognition
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §862.2100 |
Calculator/Data Processing Module, For Clinical Use
|
Class 1
|
JQP
|
| Automated instrumentation under:
Part 862 Clinical Chemistry and Clinical Toxicology Devices
Part 864 Hematology and Pathology Devices
Part 866 Immunology and Microbiological Devices |
|
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. |
|
| FDA Technical Contacts
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
