Plasma, Coagulation Control

Device Code: 2258

Product Code(s): GGN

Device Classification Information

• Device Type ID: 2258
• Device Name: Plasma, Coagulation Control
• Regulation Description: Multipurpose System For In Vitro Coagulation Studies.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 864.5425 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: GGN
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 7-101 CLSI H51-A
  Assays Of VonWillebrand Factor Antigen And Ristocetin Cofactor Activity; 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: 2258
• Device: Plasma, Coagulation Control
• Product Code: GGN
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Multipurpose System For In Vitro Coagulation Studies.
• CFR Regulation Number: 864.5425 [🔎]

Premarket Reviews
Manufacturer	Decision
AFFINITY BIOLOGICALS INC.
	SUBSTANTIALLY EQUIVALENT	1
DIAGNOSTICS STAGO S.A.S.
	SUBSTANTIALLY EQUIVALENT	1
GEORGE KING BIO-MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
INSTRUMENTATION LABORATORY
	SUBSTANTIALLY EQUIVALENT	1
MAINE STANDARDS COMPANY LLC
	SUBSTANTIALLY EQUIVALENT	3
MAINE STANDARDS COMPANY, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Use Of Device Problem	14
Adverse Event Without Identified Device Or Use Problem	13
Improper Or Incorrect Procedure Or Method	12
Human Factors Issue	5
Device Handling Problem	1
Missing Value Reason	1
Total Device Problems	46

Recalls
Manufacturer		Recall Class	Date Posted
1	TEM Systems Inc	II	Mar-09-2016

TPLC Last Update: 2019-04-02 20:08:31