Recognition List Number: 013 Publication Date: 10/31/2005
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-112: CLSI H49-A, Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline. (InVitro Diagnostics)
Date of Standard: 2004. |
| Address of Standards Organization: |
| Clinical Laboratory Standards Institute (CLSI) |
| 950 West Valley Road |
| Suite 2500 |
| Wayne, PA 19087 |
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| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR) | | DIVISION OF IMMUNOLOGY AND HEMATOLOGY DEVICES (DIHD) |
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| (2) | OFFICE OF COMPLIANCE (OC) | | |
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| Devices Affected: |
| In Vitro diagnostic POC/POL devices for the measurement of Prothrombin Time, Activated Partial Thrombinplastin Time, Activated Whole Blood Clotting Time tests, and Heparin. |
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| Processes Affected: |
| 510(k), PDP, IDE, HDE, PMA |
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| Type of Standard: |
| Horizontal, International |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §864.5400 |
Fibrometer |
Class 2 |
GIE |
| §864.5400 |
Instrument, Coagulation |
Class 2 |
KQG |
| §864.5400 |
Instrument, Coagulation, Automated |
Class 2 |
GKP |
| §864.5400 |
Timer, Clot, Automated |
Class 2 |
GKN |
| §864.5400 |
Timer, Coagulation |
Class 2 |
JBT |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §864.5425 |
System, Multipurpose For In Vitro Coagulation Studies |
Class 2 |
JPA |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §864.7140 |
Activated Whole Blood Clotting Time |
Class 2 |
JBP |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §864.7525 |
Assay, Heparin |
Class 2 |
KFF |
| §864.7525 |
Protamine Sulphate |
Class 2 |
GFT |
| §864.7525 |
Test, Heparin Neutralization |
Class 2 |
JBR |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §864.7750 |
Test, Time, Prothrombin |
Class 2 |
GJS |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §864.7925 |
Activated Partial Thromboplastin |
Class 2 |
GFO |
| §864.7925 |
Reagent & Control, Partial Thromboplastin Time |
Class 2 |
GIT |
| §864.7925 |
Reagent, Thromboplastin And Control |
Class 2 |
GGO |
| §864.7925 |
Test, Time, Partial Thromboplastin |
Class 2 |
GGW |
| |
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| Relevant Guidance: |
NCCLS C3-A3, Preparation and Testing of Reagent Water in the Clinical Laboratory; Approved Guideline-Third Edition (1997)
NCCLS C28-A2, How to Define and Determine Reference Intervals in the Clinical Laboratory; Approved Guideline-Second Edition (2000)
NCCLS H1-A4, Evacuated Tubes and Additives for Blood Specimen Collection-Fourth Edition, Approved Standard (1996)
NCCLS H3-A4, Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard-Fourth Edition (1998)
NCCLS H21-A3, Collection, Transport, and Processing of Blood Specimens for Coagulation Testing and General Performance of Coagulation Assays; Approved Guideline-Third Edition (1998)
NCCLS M29-A, Protection of Laboratory Workers from Instrument biohazards and Infectious Disease Transmitted by Blood, Body Fluids, and Tissue; Approved Guideline (1997)
FDA Points to Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) Clearance
Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators |
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| FDA Technical Contact: |
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