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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 054 Date of Entry 07/06/2020 
FR Recognition Number 9-126
CIE ISO 11664-3 First edition 2019-06 Colorimetry - Part 3: CIE tristimulus values
This document specifies methods of calculating the tristimulus values of colour stimuli for which the spectral distributions are provided. These colour stimuli can be produced by self-luminous light sources or by reflecting or transmitting objects.

This document requires that the colour stimulus function be tabulated at measurement intervals of 5 nm or less in a wavelength range of at least 380 nm to 780 nm. Extrapolation methods are suggested for cases where the measured wavelength range is less than 380 nm to 780 nm.

The standard method is defined as summation at 1 nm intervals over the wavelength range from 360 nm to 830 nm. Alternative abridged methods are defined for larger intervals (up to 5 nm) and shorter ranges (down to 380 nm to 780 nm). The alternative methods are to be used only when appropriate and when the user has reviewed the impact on the final results.

This document can be used in conjunction with the CIE 1931 standard colorimetric observer or the CIE 1964 standard colorimetric observer.

Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§876.1500 Angioscope Class 2 LYK
§876.1500 Anoscope And Accessories Class 2 FER
§876.1500 Choledochoscope And Accessories, Flexible/Rigid Class 2 FBN
§876.1500 Colonoscope And Accessories, Flexible/Rigid Class 2 FDF
§876.1500 Cystoscope And Accessories, Flexible/Rigid Class 2 FAJ
§876.1500 Cystourethroscope Class 2 FBO
§876.1500 Duodenoscope And Accessories, Flexible/Rigid Class 2 FDT
§876.1500 Endoscope, Flexible Class 2 GCQ
§876.1500 Endoscope, Rigid Class 2 GCM
§876.1500 Enteroscope And Accessories Class 2 FDA
§876.1500 Kit, Nephroscope Class 2 FGA
§876.1500 Laparoscope, General & Plastic Surgery Class 2 GCJ
§876.1500 Resectoscope Class 2 FJL
§876.1500 Sigmoidoscope And Accessories, Flexible/Rigid Class 2 FAM
§876.1500 Sigmoidoscope, Rigid, Electrical Class 2 FAN
§876.1500 Telescope, Rigid, Endoscopic Class 2 FBP
§876.1500 Ureteroscope And Accessories, Flexible/Rigid Class 2 FGB
§876.1500 Urethroscope Class 2 FGC
§884.1630 Colposcope (And Colpomicroscope) Class 2 HEX
§884.1630 Vaginoscope And Accessories Class 2 MOK
§884.1640 Culdoscope (And Accessories) Class 2 HEW
§884.1690 Falloposcope Class 2 MKO
§884.1690 Hysteroscope (And Accessories) Class 2 HIH
§884.1720 Laparoscope, Gynecologic (And Accessories) Class 2 HET
§864.1860 Automated Digital Image Manual Interpretation Microscope Class 2 OEO
§864.3700 Digital Pathology Display Class 2 PZZ
§864.3700 Digital Pathology Image Viewing And Management Software Class 2 QKQ
§864.3700 Whole Slide Imaging System Class 2 PSY
Relevant FDA Guidance and/or Supportive Publications*
* Submission Guidance for a 510(k): Hysteroscopes and Gynecologic Laparoscopes, Issued March 7, 1996.
* Guidance for Industry and FDA Staff: Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices, Issued April 2016.
* Cheng, W.C., Saleheen, F., and Badano, A. (2019). Assessing color performance of whole-slide imaging scanners for digital pathology. Color Research & Application, 44(3), 322-334.
* Lemaillet P. & Cheng W.C. (2020). Colorimetrical uncertainty of a hyperspectral imaging microscopy system for assessing whole-slide imaging devices. Biomedical Optics Express, 11(3), 1449-1461.
FDA Technical Contact
 Wei-Chung Cheng
Standards Development Organizations
CIE International Commission on Illumination http://cie.co.at/
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Groups (STG)
ObGyn/Gastroenterology/Urology (primary)
*These are provided as examples and others may be applicable.