| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
050
|
Date of Entry 09/17/2018
|
|
FR Recognition Number
|
7-277
|
| Standard | |
CLSI GP41 7th Edition
Collection of Diagnostic Venous Blood Specimens |
|
Scope/Abstract| This standard establishes criteria for suitable venous blood specimen collection for medical laboratory testing. These procedures are intended as an appropriate model for adoption by all health care providers responsible for blood specimen collection in outpatient and inpatient settings. |
|
| Extent of Recognition
|
Rationale for Recognition
| The standard provides processes and procedures that are appropriate for venous blood specimen collection for the clinical laboratory testing. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
|
§862.1675
|
Blood specimen collection device. Tubes, Vacuum Sample, With Anticoagulant
|
Class 2
|
GIM
|
|
§862.1675
|
Blood specimen collection device. Tubes, Vials, Systems, Serum Separators, Blood Collection
|
Class 2
|
JKA
|
| §864.5220 |
Counter, Differential Cell
|
Class 2
|
GKZ
|
| §864.7750 |
Test, Time, Prothrombin
|
Class 2
|
GJS
|
| §864.7925 |
Activated Partial Thromboplastin
|
Class 2
|
GFO
|
|
Relevant FDA Guidance and/or Supportive Publications*
CLSI GP39-A6 Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved Standard - Sixth Edition.
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
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
