Activated Partial Thromboplastin

Device Code: 2247

Product Code(s): GFO

Device Classification Information

• Device Type ID: 2247
• Device Name: Activated Partial Thromboplastin
• Regulation Description: Partial Thromboplastin Time Tests.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 864.7925 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: GFO
• GMP Exempt: No
• Summary MR: Ineligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 7-112 CLSI POCT14-A (Formerly H49-A)
  Point-of-Care Monitoring Of Anticoagulation Therapy; Approved Guideline
• 7-159 CLSI H21-A5
  Collection, Transport, And Processing Of Blood Specimens For Testing Plasma-Based Coagulation Assays And Molecular Hemostasis Assays
• 7-205 CLSI H47-A2
  One-Stage Prothrombin Time (PT) Test And Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline - Second Edition.
• 7-277 CLSI GP41 7th Edition
  Collection Of Diagnostic Venous Blood Specimens

Total Product Life Cycle

• Device Type ID: 2247
• Device: Activated Partial Thromboplastin
• Product Code: GFO
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Partial Thromboplastin Time Tests.
• CFR Regulation Number: 864.7925 [🔎]

Premarket Reviews
Manufacturer	Decision
INSTRUMENTATION LABORATORY
	SUBSTANTIALLY EQUIVALENT	1
INSTRUMENTATION LABORATORY CO.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Adverse Event Without Identified Device Or Use Problem	15
High Test Results	11
Total Device Problems	26

Recalls
Manufacturer		Recall Class	Date Posted
1	Diagnostica Stago, Inc.	II	Dec-14-2018
2	ITC-Nexus Dx	II	Feb-06-2014
3	Siemens Healthcare Diagnostics, Inc.	II	Jun-02-2015

TPLC Last Update: 2019-04-02 20:08:20