Activated Whole Blood Clotting Time

Device Code: 2338

Product Code(s): JBP

Device Classification Information

• Device Type ID: 2338
• Device Name: Activated Whole Blood Clotting Time
• Regulation Description: Activated Whole Blood Clotting 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: 864.7140 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: JBP
• 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

Total Product Life Cycle

• Device Type ID: 2338
• Device: Activated Whole Blood Clotting Time
• Product Code: JBP
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Activated Whole Blood Clotting Time Tests.
• CFR Regulation Number: 864.7140 [🔎]

Device Problems
Incorrect, Inadequate Or Imprecise Result Or Readings	8
Incorrect Or Inadequate Test Results	8
High Test Results	6
False Negative Result	5
False Positive Result	3
Adverse Event Without Identified Device Or Use Problem	2
Charging Problem	1
Overheating Of Device	1
Total Device Problems	34

TPLC Last Update: 2019-04-02 20:10:03