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2019 Biological Device Application Approvals

2019 Biological Device Application Approvals

This list reflects information regarding the applications as of the approval/clearance date. It is not updated with regard to applicant or application status changes. The applications are listed in order by date of approval / clearance in reverse chronological order.

2019 Biological Device Application Approvals
Tradename/Common Name Description and Indication for Device Submission ID Manufacturer Clearance Date
TANGO infinity
Automated Blood Grouping and Antibody Test Systems
The TANGO infinity automated blood grouping and antibody test system is an automated instrument intended for the in vitro serological analysis of human blood specimens. In the USA, TANGO infinity is ''Rx only'' and operates with TANGO infinity Software Version 1.5. It generates results from individual images that must be verified by visual inspection by a qualified person called a validator. In rare cases, where the software is unable to decide, manual editing may be necessary.

TANGO infinity utilizes Erytype S agglutination methodology for ABO (forward and reverse blood grouping), Rh(D), Rh Phenotype and Kell blood grouping.

TANGO infinity utilizes Solidscreen II solidphase methodology for weak D and partial D testing, antibody screening and identification of red cell alloantibodies, crossmatch, auto control and direct antiglobulin testing. The TANGO infinity uses reagents and microwell strips approved for the TANGO infinity.

Operators of TANGO infinity must be trained by authorized personnel and must be familiar with the content of this TANGO infinity User Manual.

This TANGO infinity User Manual is designed to serve as a reference manual for operations and troubleshooting, to assist writing institutional SOPs and to assist training.
BK190312/0 Bio-Rad Medical Diagnostics GmbH
Bio-Rad Laboratories, Inc.
6565 185th Avenue, NE
Redmond, WA 98052
04/24/2019
VISTASEAL Airless Spray Accessory
Fibrin Sealant Preparation Device
The VistaSeal Airless Spray Accessory device is intended to be used with VistaSeal Fibrin Sealant (Human) for the simultaneous topical application of the two biological components of VistaSeal Fibrin Sealant (Human) onto the surface. BK180287/0 ETHICON Inc.
Route 22 West,
Somerville, NJ 08876
04/10/2019
XCELL PRP™ Platelet Concentrating System 60ml
Platelet And Plasma Separator For Bone Graft Handling
The XCELL PRP™ System is intended to be used for the safe and rapid preparation of autologous platelet-rich plasma (PRP) from a small sample of peripheral blood at the patient’s point of care. The PRP is mixed with autograft and/or allograft bone prior to the application to a bony defect for improving handling characteristics. BK180252/0 APEX Biologix
5650 South Green St,
Murray, UT 84123
04/05/2019
IH-500 Analyzer
Automated Blood Grouping and Antibody Test System
The IH-500 is an automated instrument intended for the in vitro serological analysis for blood grouping and antibody detection of human blood specimens. The IH-500 automates pipetting of samples and reagents, incubation and centrifugation, provides reaction grading / interpretation based on results from gel card images. Analysis includes ABO, Rh(D) (including weak D and partial D testing), Rh Phenotype and Kell blood grouping, antibody screening and identification of red blood cell alloantibodies, crossmatch, auto control and direct antiglobulin testing. BK180274/0 Bio-Rad Medical Diagnostics GmbH
Bio-Rad Laboratories, Inc.
6565 185th Avenue, NE
Redmond, WA 98052
03/21/2019
IH-Com V5.0
Automated Blood Grouping and Antibody Test System
IH-Com V5.0 is data management and result interpretation software used in immunohematology testing to analyze reaction images for blood samples that are tested on the IH-1000, IH-500 and IH-Reader 24 with IH-System reagents or the TANGO infinity® with reagents specifically formulated and manufactured by Bio-Rad Medical Diagnostics GmbH. It manages sample, patient, donor, QC and reagent data. IH-Com V5.0 may be used with:
  • a standalone or multiple IH-1000 systems,
  • a standalone or multiple IH-500 systems,
  • a standalone or multiple IH-Reader 24 systems,
  • a standalone TANGO infinity® or multiple TANGO infinity® systems; or connected to a Laboratory Information System.
IH-Com V5.0 should only be operated by trained personnel and is not intended for use in a direct patient environment. In the USA IH-Com is "Rx only".
BK180275/0 Bio-Rad Medical Diagnostics GmbH
Bio-Rad Laboratories, Inc.
6565 185th Avenue, NE
Redmond, WA 98052
03/21/2019
Arthrex Thrombinator System
Platelet And Plasma Separator For Bone Graft Handling
The Thrombinator System for use with Arthrex PRP systems (Arthrex Angel concentrated Platelet Rich Plasma cPRP System or Arthrex Double Syringe (ACP) System) is designed for the preparation of autologous serum from anticoagulated or non-anticoagulated peripheral blood, platelet poor plasma, or platelet rich plasma (PRP) that is to be mixed with PRP and autograft or allograft bone prior to application to a bony defect for improving handling characteristics. BK180299/0 Arthrex, Inc.
1370 Creekside Boulevard,
Naples, FL 34108
03/07/2019
ALBAcyte® lgG Sensitized Red Blood Cells II
Quality Control Kits for Blood Banking Reagents

These IgG Sensitized Red Blood Cells are for the control of the Indirect Antiglobulin Test (IAT) and Direct Antiglobulin Test (DAT).

BK180286/0 Alba Bioscience Limited
James Hamilton Way,
Penicuik, Midlothian EH26 OBF United Kingdom
02/05/2019
MacoPress Smart Smarter and DMS Plus
Blood Bank Supplies
The MacoPress Smart Smarter and DMS Plus consist of two parts: the MacoPress Smart Smarter device and the DMS Plus management software.

The MacoPress Smart Smarter is intended as an automated blood component separator used for blood component separation and preparation. With the use of the DMS Plus software, the separation procedures can be programmed to collect data of manufacturer components that can then be recorded, stored and analyzed.
BK180306/0 MacoProductions S.A.S.
MacoPharma USA
3075 Breckinridge Boulevard, Suite 405
Duluth, GA 30096
01/24/2019
Vista Information System
Blood Establishment Computer Software and Accessories
The Vista System is intended for use in facilities that are automating the process associated with managing donor information, including information about blood collection and manufacture of blood components, with the following functions:
  • Managing donor data such as blood loss history, donor vital signs relevant to blood collection, and demographics
  • Storing and reporting device-connected and manually entered collection procedure information
  • Determining donor eligibility by considering donor blood loss history, user-configured eligibility parameters, and immediate safety qualifications
  • Interfacing with the Trima® Accel Automated Blood Collection System
  • Aiding in the management of these blood establishment processes:
    • - Trima Accel system configuration management
    • - Periodic review of platelet count and other indicators of donor health
    • - Prioritization and management of blood component collection
  • Exchanging data with blood establishment computer systems (BECS)
  • Collecting and managing data associated with whole blood and apheresis collection procedures
BK180258/0 Terumo BCT, Inc
10811 W. Collins Ave.,
Lakewood, CO 80215
01/18/2019
DG Gel Essential Control
Quality Control Kits for Blood Banking Reagents
DG Gel Essential Control is intended to allow regular quality control of materials, work procedures and instrument procedures for:

(i) the determination of the ABO, Rh and K antigens;
(ii) the determination of the appropriate ABO blood group antibodies;
and (iii) the detection of unexpected antibodies.

For use with DG Gel 8 technique. For in vitro diagnostic use.
BK180280/0 Medion Grifols Diagnostics AG
Grifols SA
Avda. de la generalitat, 152
Sant cugat del valles 08174
Spain
01/17/2019