Plasma, Coagulation Factor Deficient

Device Code: 2300

Product Code(s): GJT

Device Classification Information

• Device Type ID: 2300
• Device Name: Plasma, Coagulation Factor Deficient
• Regulation Description: Factor Deficiency Test.
• 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: 864.7290 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: GJT
• 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: 2300
• Device: Plasma, Coagulation Factor Deficient
• Product Code: GJT
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Factor Deficiency Test.
• CFR Regulation Number: 864.7290 [🔎]

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

Device Problems
High Test Results	6
Incorrect Or Inadequate Test Results	1
Total Device Problems	7

Recalls
Manufacturer		Recall Class	Date Posted
1	Siemens Healthcare Diagnostics, Inc.	II	Jun-05-2015

TPLC Last Update: 2019-04-02 20:09:12