| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
028
|
Date of Entry 03/16/2012
|
|
FR Recognition Number
|
7-165
|
| Standard | |
CLSI H20-A2 (Replaces H20-A)
Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard - Second Edition |
|
| Extent of Recognition
|
Rationale for Recognition
| This document is a reference method for the evaluation of automated differential counters, based on the visual differential count. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §864.5220 |
Counter, Differential Cell
|
Class 2
|
GKZ
|
| §864.5260 |
Device, Automated Cell-Locating
|
Class 2
|
JOY
|
|
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.
Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA, Issued December 2001.
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. |
