Test, Qualitative And Quantitative Factor Deficiency

Device Code: 2260

Product Code(s): GGP

Device Classification Information

• Device Type ID: 2260
• Device Name: Test, Qualitative And Quantitative Factor Deficiency
• 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: GGP
• 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: 2260
• Device: Test, Qualitative And Quantitative Factor Deficiency
• Product Code: GGP
• 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
PRECISION BIOLOGIC
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
High Test Results	3
Incorrect, Inadequate Or Imprecise Result Or Readings	2
Insufficient Information	1
Adverse Event Without Identified Device Or Use Problem	1
Device Operates Differently Than Expected	1
Total Device Problems	8

Recalls
Manufacturer		Recall Class	Date Posted
1	Helena Laboratories, Inc.	II	Oct-12-2018
2	Instrumentation Laboratory Co.	II	Feb-01-2016
3	Siemens Healthcare Diagnostics, Inc.	II	Dec-22-2015

TPLC Last Update: 2019-04-02 20:08:33