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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 022 FR Publication Date: 09/08/2009 

Part B: Supplementary Information

Recognition Number 7-203: CLSI H04-A6, procedures and devices for the collection of diagnostic capillary blood specimens. (InVitro Diagnostics)

Date of Standard: 2008. 
Address of Standards Development Organization:
 Clinical Laboratory Standards Institute (CLSI)
  950 West Valley Road
  Suite 2500
  Wayne, PA 19087
 
CDRH Office and Division associated with recognized standards:
OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
Devices Affected:
Any device for which venous blood may be used but for which venous samples cannot be practically or safely obtained because of patient characteristics (infants, burn patients, etc); devices intended for the point of care or for home use and for which capillary sampling is the only practical blood collection method.
Processes Affected:
510(k), PMA, IDE, HDE
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§862.1225 Alkaline Picrate, Colorimetry, Creatinine Class 2 CGX
§862.1225 Electrode, Ion Based, Enzymatic, Creatinine Class 2 CGL
§862.1225 Enzymatic Method, Creatinine Class 2 JFY
§862.1225 Test, Creatinine, Over The Counter Class 2 NFZ
§862.1225 Test, Cystatin C Class 2 NDY
§862.1345 Copper Reduction, Glucose Class 2 CFW
§862.1345 Drink, Glucose Tolerance Class 2 MRV
§862.1345 Ferricyanide, Glucose Class 2 CGD
§862.1345 Glucose Dehydrogenase, Glucose Class 2 LFR
§862.1345 Glucose Oxidase, Glucose Class 2 CGA
§862.1345 Hexokinase, Glucose Class 2 CFR
§862.1345 Orthotoluidine, Glucose Class 2 CGE
§862.1345 System, Test, Blood Glucose, Over The Counter Class 2 NBW
§862.1675 Tubes, Vials, Systems, Serum Separators, Blood Collection Class 2 JKA
§864.5425 System, Multipurpose For In Vitro Coagulation Studies Class 2 JPA
FDA Technical Contact:
 Yung Chan
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5630
  Silver Spring MD 20993
  301/796-6138
  email: yung.chan@fda.hhs.gov
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