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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 036 FR Publication Date: 07/09/2014 

Part B: Supplementary Information

Recognition Number 7-221: CLSI GP36-A6 (Formerly H01-A6), tubes and additives for venous blood specimen collection; approved standard-sixth edition. (InVitro Diagnostics)

Date of Standard: 2010. 
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 IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
DIVISION OF IMMUNOLOGY AND HEMATOLOGY DEVICES (DIHD)
(3)OFFICE OF COMPLIANCE (OC)
Devices Affected:
In vitro diagnostic devices (evacuated tubes and related additives) for collection of venous whole blood, plasma and serum specimens for chemistry, hematology, and immunology laboratory procedures.
Processes Affected:
510(K), HDE, IDE, PDP, PMA
Type of Standard:
 National, Horizontal
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§862.1675 Tubes, Vacuum Sample, With Anticoagulant Class 2 GIM
§862.1675 Tubes, Vials, Systems, Serum Separators, Blood Collection Class 2 JKA
Relevant Guidance:
Points to Consider for Collection of Data in Support of In Vitro Device Submissions for 510(k) Clearance
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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