| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
055
|
Date of Entry 12/21/2020
|
|
FR Recognition Number
|
7-299
|
| Standard | |
CLSI POCT14 2nd Edition
Point-of-Care Coagulation Testing and Anticoagulation Monitoring |
|
Scope/Abstract| This guideline provides recommendations for establishing and/or assessing performance characteristics of traditional assays for coagulation assessment and anticoagulation management that are performed at the point of care (POC). These tests include those used for monitoring vitamin K antagonists (VKAs) (eg, prothrombin time/international normalized ratio [PT/INR]) and heparin (eg,activated partial thromboplastin time [APTT], activated clotting time [ACT], and heparin concentration). POCT14 also includes recommendations for use of point-of care testing (POCT) when APTT and PT/INR are used to evaluate individuals for suspected coagulopathies before or after invasive procedures or in association with the administration of certain pharmaceutical agents. This guideline provides minimal reference to the use of point-of-care coagulation testing (POC-CT) for monitoring direct thrombin inhibitors (DTIs). Potential assay interferences, including direct oral anticoagulants (DOACs), are briefly discussed. |
|
| Extent of Recognition
|
Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §864.5400 |
Fibrometer
|
Class 2
|
GIE
|
| §864.5400 |
Timer, Clot, Automated
|
Class 2
|
GKN
|
| §864.5400 |
Instrument, Coagulation, Automated
|
Class 2
|
GKP
|
| §864.5400 |
Timer, Coagulation
|
Class 2
|
JBT
|
| §864.5400 |
Instrument, Coagulation
|
Class 2
|
KQG
|
| §864.5425 |
System, Multipurpose For In Vitro Coagulation Studies
|
Class 2
|
JPA
|
| §864.7140 |
Activated Whole Blood Clotting Time
|
Class 2
|
JBP
|
| §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
|
| §864.7925 |
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
|
|
Relevant FDA Guidance and/or Supportive Publications*
CLSI C3-A3 Preparation and Testing of Reagent Water in the Clinical Laboratory; Approved Guideline- Third Edition.
CLSI C28-A2 How to Define and Determine Reference Intervals in the Clinical Laboratory; Approved Guideline - Second Edition.
CLSI GP39-A6 (Formerly H01-A6) Tubes and Additives for Venous Blood Specimen Collection; Approved Standard-Sixth Edition.
CLSI H21-A5 Collection, Transport, and Processing of Blood Specimens for Testing Plasma-based Coagulation Assays and Molecular Hemostasis Assays.
Points to Consider for Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) Clearance, Issued September 1994.
Guidance for Industry Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators, Issued February 1999.
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. |
