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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 055 Date of Entry 12/21/2020 
FR Recognition Number 7-302
CLSI  C34 4th Edition
Sweat Testing: Specimen Collection and Quantitative Chloride Analysis
This guideline provides recommendations for sweat stimulation by pilocarpine iontophoresis (specific precautions are noted), sweat collection in filter paper or gauze (see Appendix A) or in a commercial sweat collector using coiled tubing (see Appendix B), and quantitative chloride measurement. The procedure for sweat chloride (chloride ion [Cl−]) determination using coulometric titration is described. Sweat conductivity screening methods are also mentioned. Sweat chloride test results evaluation, including reference intervals and diagnostic criteria, is described, with an emphasis on sweat chloride testing for newborn cystic fibrosis (CF) screening. Validation studies and QA techniques are discussed, along with
analytical and biological error sources.

The intended users of this guideline are laboratory and clinical personnel responsible for collecting sweat specimens, measuring sweat chloride, and evaluating and reporting sweat test results.
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)*
CFR 862, 864
Relevant FDA Guidance and/or Supportive Publications*
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
 Yung Chan
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.