Test, Time, Partial Thromboplastin

Device Code: 2263

Product Code(s): GGW

Device Classification Information

• Device Type ID: 2263
• Device Name: Test, Time, 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: GGW
• 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

Total Product Life Cycle

• Device Type ID: 2263
• Device: Test, Time, Partial Thromboplastin
• Product Code: GGW
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Partial Thromboplastin Time Tests.
• CFR Regulation Number: 864.7925 [🔎]

Device Problems
High Test Results	16
Adverse Event Without Identified Device Or Use Problem	15
Low Test Results	6
Incorrect, Inadequate Or Imprecise Result Or Readings	3
Use Of Device Problem	1
Total Device Problems	41

TPLC Last Update: 2019-04-02 20:08:37