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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 028 FR Publication Date: 03/16/2012 

Part B: Supplementary Information

Recognition Number 7-165: CLSI H20-A2, reference leukocyte (wbc) differential count (proportional) and evaluation of instrumental methods; approved standard - second edition. (InVitro Diagnostics)

Date of Standard: 2007. 
Address of Standards Development Organization:
 Clinical Laboratory Standards Institute (CLSI)
  950 West Valley Road
  Suite 2500
  Wayne, PA 19087
 
CDRH Office and Division associated with recognized standards:
OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
Devices Affected:
Automated hematology analyzers, automated differential cell counters
Processes Affected:
White blood cell differential counts in blood films
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
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 Guidance:
Class II Special Controls Guidance Document: Premarket Notfications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA

Points to Consider for Collection of Data in Support of In Vitro Device Submissions for 510(k) Clearance
FDA Technical Contact:
 Jeb Monasterial
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5216
  Silver Spring MD 20993
  301/796-9677
  email: jeb.monasterial@fda.hhs.gov
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