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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 011 FR Publication Date: 09/01/2004 

Part B: Supplementary Information

Recognition Number 7-104: NCCLS H7-A3, procedure for determining packed cell volume by the microhematocrit method - second edition; approved standard - third edition. (InVitro Diagnostics)

Date of Standard: 2000. 
Address of Standards Development Organization:
 National Committee for Clinical Laboratory Standards (NCCLS)
  950 West Valley Road
  Suite 2500
  Wayne, PA 19087
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
DIVISION OF IMMUNOLOGY AND HEMATOLOGY DEVICES (DIHD)
(2)OFFICE OF COMPLIANCE (OC)
Devices Affected:
In vitro diagnostic devices for measuring packed cell volume
Whole blood calibration of instrument methods
Processes Affected:
510(K), PMA, IDE
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§864.5600 Instrument, Hematocrit, Automated Class 2 GKF
§864.6400 Device, Hematocrit Measuring Class 2 JPI
§864.8165 Calibrator For Hemoglobin And Hematocrit Measurement Class 2 KRZ
Relevant Guidance:
Points to Consider for Collection of Data in support of In Vitro Device Submissions for 510(k) Clearance
NCCLS M29- Protection of Laboratory Workers from Instruments Biohazards and Infection Disease Transmitted by Blood, Body Fluids and Tissue.
FDA Technical Contact:
 Yvonne Doswell
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5213
  Silver Spring MD 20993
  240/402-5025
  email: yvonne.doswell@fda.hhs.gov
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