Fibrin Split Products

Device Code: 2270

Product Code(s): GHH

Device Classification Information

• Device Type ID: 2270
• Device Name: Fibrin Split Products
• Regulation Description: Fibrinogen/fibrin Degradation Products 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: 864.7320 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: GHH
• GMP Exempt: No
• Summary MR: Ineligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 7-159 CLSI H21-A5
  Collection, Transport, And Processing Of Blood Specimens For Testing Plasma-Based Coagulation Assays And Molecular Hemostasis Assays
• 7-220 CLSI H59-A (Replaces H59-P)
  Quantitative D-dimer For The Exclusion Of Venous Thromboembolic Disease; Approved Guideline.

Total Product Life Cycle

• Device Type ID: 2270
• Device: Fibrin Split Products
• Product Code: GHH
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Fibrinogen/fibrin Degradation Products Assay.
• CFR Regulation Number: 864.7320 [🔎]

Device Problems
High Test Results	21
Low Test Results	18
Incorrect Or Inadequate Test Results	6
Test Strip	6
Incorrect, Inadequate Or Imprecise Result Or Readings	5
Non Reproducible Results	4
False Negative Result	1
Total Device Problems	61

Recalls
Manufacturer		Recall Class	Date Posted
1	Alere San Diego, Inc.	II	Jun-06-2014
2	BBI SOLUTIONS OEM LTD	II	Oct-27-2016
3	Lsi Medience Corporation	II	Nov-21-2016

TPLC Last Update: 2019-04-02 20:08:42