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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 009 FR Publication Date: 03/08/2004 

Part B: Supplementary Information

Recognition Number 7-86: CLSI C29-A2, standardization of sodium and potassium ion selective electrode systems to the flame photometric reference method; approved standard (2000) isbn 1-56238-406-6. (InVitro Diagnostics)

Date of Standard: 2000. 
Address of Standards Development Organization:
 Clinical Laboratory Standards Institute (CLSI)
  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 CHEMISTRY AND TOXICOLOGY DEVICES (DCTD)
(2)OFFICE OF COMPLIANCE (OC)
Devices Affected:
In Vitro Diagnostic devices for the measurement of sodium and potassium using ion-selective electrodes system
Processes Affected:
510(K), PMA, PDP, IDE, HDE
Type of Standard:
 National, Horizontal
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§862.1600 Electrode, Ion Specific, Potassium Class 2 CEM
§862.1665 Electrode, Ion Specific, Sodium Class 2 JGS
Relevant Guidance:
Points to Consider for Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) Clearance Guidance for Industry In Vitro Diagnostic Potassium Test System Guidance for Industry In Vitro Diagnostic Sodium Test System.
FDA Technical Contact:
 Tracey Bosworth
  OMPT/CDRH/OIR/DCTD/CHTB
  10903 New Hampshire Avenue WO66 RM 4616
  Silver Spring AA 20993
  301/796-2981
  email: Tracey.Bosworth@fda.hhs.gov
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