• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 

New Search Back To Search Results
Recognition List Number: 036 FR Publication Date: 07/09/2014 

Part B: Supplementary Information

Recognition Number 7-162: CLSI POCT14-A (Formerly H49-A), point-of-care monitoring of anticoagulation therapy; approved guideline. (InVitro Diagnostics)

Date of Standard: 2004. 
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 COMPLIANCE (OC)
(2)OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
DIVISION OF IMMUNOLOGY AND HEMATOLOGY DEVICES (DIHD)
Devices Affected:
In Vitro diagnostic POC/POL devices for the measurement of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Activated Whole Blood Clotting Time tests (ACT), Heparin Concentration and Coagulation Instruments
Processes Affected:
510(k), PDP, IDE, HDEM PMA
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§862.1150 Calibrator, Primary Class 2 JIS
§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
§864.5425 System, Multipurpose For In Vitro Coagulation Studies Class 2 JPA
§864.5680 Analyzer, Heparin, Automated Class 2 JOX
§864.7140 Activated Whole Blood Clotting Time Class 2 JBP
§864.7525 Assay, Heparin Class 2 KFF
§864.7525 Protamine Sulphate Class 2 GFT
§864.7525 Test, Heparin Neutralization Class 2 JBR
§864.7750 Test, Time, Prothrombin Class 2 GJS
§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
Relevant Guidance:
Point to consider for Collection of Data in Support of In Vitro Device Submission for 510(k) clearance

510(k) Submission for Coagulation Instruments - Guidance for Industry and FDA Staff
FDA Technical Contact:
 Lea Carrington
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 4224
  Silver Spring MD 20993
  301/796-6164
  email: lea.carrington@fda.hhs.gov
-
-