| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
020
|
Date of Entry 09/09/2008
|
|
FR Recognition Number
|
7-159
|
| Standard | |
CLSI H21-A5
Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays |
|
Scope/Abstract| This document contains procedures for collecting, transporting, and storing blood; processing blood specimens; storing plasma for coagulation testing; and provides general recommendations for performing the tests. |
|
| Extent of Recognition
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §864.5400 |
Fibrometer
|
Class 2
|
GIE
|
| §864.5425 |
Control, Plasma, Abnormal
|
Class 2
|
GGC
|
| §864.5425 |
Plasma, Coagulation Control
|
Class 2
|
GGN
|
| §864.5425 |
Plasma, Control, Normal
|
Class 2
|
GIZ
|
| §864.5425 |
System, Multipurpose For In Vitro Coagulation Studies
|
Class 2
|
JPA
|
| §864.5680 |
Analyzer, Heparin, Automated
|
Class 2
|
JOX
|
| §864.7060 |
Antigen, Antiserum, Control, Antithrombin Iii
|
Class 2
|
DDQ
|
| §864.7060 |
Antithrombin Iii Quantitation
|
Class 2
|
JBQ
|
| §864.7060 |
Antithrombin Iii, Two Stage Clotting Time Assay
|
Class 2
|
JPE
|
| §864.7290 |
Test, Qualitative And Quantitative Factor Deficiency
|
Class 2
|
GGP
|
| §864.7290 |
Plasma, Coagulation Factor Deficient
|
Class 2
|
GJT
|
| §864.7320 |
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
|
Class 2
|
DAP
|
| §864.7320 |
Fibrin Split Products
|
Class 2
|
GHH
|
| §864.7525 |
Protamine Sulphate
|
Class 2
|
GFT
|
| §864.7525 |
Test, Heparin Neutralization
|
Class 2
|
JBR
|
| §864.7525 |
Assay, Heparin
|
Class 2
|
KFF
|
| §864.7750 |
Test, Time, Prothrombin
|
Class 2
|
GJS
|
| §864.7875 |
Test, Thrombin Time
|
Class 2
|
GJA
|
| §864.7875 |
Thrombin
|
Class 2
|
GJB
|
| §864.7925 |
Activated Partial Thromboplastin
|
Class 2
|
GFO
|
| §864.7925 |
Reagent, Thromboplastin And Control
|
Class 2
|
GGO
|
| §864.7925 |
Test, Time, Partial Thromboplastin
|
Class 2
|
GGW
|
| §864.7925 |
Reagent & Control, Partial Thromboplastin Time
|
Class 2
|
GIT
|
| §864.8950 |
Reagent, Russel Viper Venom
|
Class 1
|
GIR
|
|
Relevant FDA Guidance and/or Supportive Publications*
CLSI EP28-A3c Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline Third Edition.
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. |
|
|
