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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 011 Date of Entry 10/04/2004 
FR Recognition Number 7-104
Procedure for Determining Packed Cell Volume by the Microhematocrit Method - Second Edition; Approved Standard - Third Edition.
The standard is intended for reference use by clinical laboratory personnel and by manufacturers of instruments that determine PCV. The method can also be used (with appropriate precautions as described in the document) in the clinical laboratory for diagnostic purposes, for monitoring a patient's response to therapy, and for evaluating instruments and other methods for determining PCV; the standard should be used for whole blood calibration procedures of hematology analyzers. The document gives detailed specifications of the materials to be used in the procedure, contains information for calibrating the centrifuge and reading device, and includes information on verification of calibration. Expression of results, generally accepted reference values, and potential sources of error are given.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§864.5600 Automated hematocrit instrument.
§864.6400 Device, Hematocrit Measuring Class 2 JPI
§864.8165 Calibrator for hemoglobin or hematocrit measurement.
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
 Elizabeth Stafford
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
*These are provided as examples and others may be applicable.