Assay, Heparin

Device Code: 2374

Product Code(s): KFF

Device Classification Information

• Device Type ID: 2374
• Device Name: Assay, Heparin
• Regulation Description: Heparin Assay.
• 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: 864.7525 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: KFF
• 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: 2374
• Device: Assay, Heparin
• Product Code: KFF
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Heparin Assay.
• CFR Regulation Number: 864.7525 [🔎]

Premarket Reviews
Manufacturer	Decision
SIEMENS HEALTHCARE DIAGNOSTICS PRODCTS GMBH
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Adverse Event Without Identified Device Or Use Problem	5
Low Test Results	3
Imprecision	1
Incorrect Or Inadequate Test Results	1
Total Device Problems	10

Recalls
Manufacturer		Recall Class	Date Posted
1	Diagnostica Stago, Inc.	III	Sep-16-2014

TPLC Last Update: 2019-04-02 20:10:40