U.S. flag An official website of the United States government
  1. Home
  2. Vaccines, Blood & Biologics
  3. Development & Approval Process (CBER)
  4. 2019 Biological Device Application Approvals
  1. Vaccines, Blood & Biologics

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
Galileo NEO
Automated Blood Grouping and Antibody Test Systems
The Galileo Neo (NEO) is a microprocessor-controlled instrument to fully automate immunohematology in vitro diagnostic testing of human blood. The NEO automates test processing, result interpretation and data management functions. The NEO is designed to automate standard immunohematology assays using a microplate-based platform. Assays include ABO grouping and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, red blood cell phenotyping, antigen screening and infectious disease screening, such as cytomegalovirus (CMV). The antigen screening assays provide guidelines for the user to select antisera or dilute commercial blood grouping reagents as a mechanism to pre-screen for antigen negative blood units that can then be subjected to confirmation using a licensed method. The NEO is intended for use only with the reagents described in Attachment 1 for Galileo Neo Operator Manual. BK190337/0 Immucor, Inc.
3130 Gateway Drive
Norcross, GA 30071
06/19/2019
VISTASEAL™ Laparoscopic Dual Applicator (35 cm Rigid or 45 cm Flexible)
Fibrin Sealant Preparation Device
The VISTASEAL™ Laparoscopic Dual Applicator (35 cm Rigid or 45 cm Flexible) is intended to be used with the VISTASEAL™ Dual Applicator for the simultaneous topical application of the two biological components ofVISTASEAL™ Fibrin Sealant (Human) onto the surface. BK190324/0 ETHICON Inc.
Route 22 West,
P.O. Box 151,
Somerville, NJ 08876
06/05/2019
ALYX Component Collection System
Automated Blood Cell Separators
The ALYX Component Collection System is intended for use in blood collection establishments to collect and separate whole blood into its components.

Depending on the ALYX Component Collection system apheresis kit used in the collection of products, the ALYX Component Collection System has been cleared for:

• Concurrent collection of two units of Red Blood Cells (2RBC), Leukocytes Reduced
− Single Unit Recovery (One Unit of Red Blood Cells, Non-Leukocytes Reduced) permitted

• Concurrent collection of two units of Red Blood Cells (2RBC), Non-Leukocytes Reduced
− Single Unit Recovery (One Unit of Red Blood Cells, Non-Leukocytes Reduced) permitted

• Concurrent collection of One Unit of Red Blood Cells, Leukocytes Reduced, and Plasma as:
− Fresh Frozen Plasma
• Must be prepared and placed in a freezer at -18°C or colder within 8 hours after phlebotomy.
− Source Plasma
− Plasma Frozen Within 24 Hours After Phlebotomy (PF24)
• Must be stored at 1-6°C within 8 hours after phlebotomy and placed in a freezer at - 18°C or colder within 24 hours after phlebotomy.
• Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.
− Plasma Frozen Within 24 Hours After Phlebotomy Held At Room Temperature Up To 24 Hours After Phlebotomy (PF24RT24)
• Can be stored at room temperature for up to 24 hours after phlebotomy.
• Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.

• Collection of Plasma as:
− Fresh Frozen Plasma,
• Must be prepared and placed in a freezer at -18°C or colder within 8 hours after phlebotomy.
− Source Plasma
− Plasma Frozen Within 24 Hours After Phlebotomy (PF24)
• Must be stored at 1-6°C within 8 hours after phlebotomy and placed in a freezer at - 18°C or colder within 24 hours after phlebotomy.
• Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.
− Plasma Frozen Within 24 Hours After Phlebotomy Held At Room Temperature Up To 24 Hours After Phlebotomy (PF24RT24)
• Can be stored at room temperature for up to 24 hours after phlebotomy. Product must be placed in a freezer at -18°C or colder within 24 hours after phlebotomy.
• Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.
BK190351/0 Fresenius Kabi USA LLC.
Three Corporate Drive
Lake Zurich, IL 60047
06/04/2019
Trima Accel Automated Blood Collection System
Automated Blood Cell Separators
The Trima Accel system is an automated blood cell separator intended for use in collecting blood components for later transfusion into patients.
Depending on the disposable tubing set used, the Trima Accel system has been cleared to collect:
  • Double ACD-A/AS-3 Red Blood Cells (leukocytes reduced or not leukoreduced)

Or the following products alone or in combination:
  • ACD-A/AS-3 Red Blood Cells
  • ACD-A/AS-3 Red Blood Cells, Leukocytes Reduced utilizing an integrated filter (TLR gravity drain filter or Auto RBC filter)
  • Platelets Pheresis, Leukocytes Reduced (single, double, or triple units)
  • Platelets Pheresis, Leukocytes Reduced, Platelet Additive Solution (Isoplate or InterSol) (single, double, or triple units)
  • Plasma for Fresh Frozen Plasma and Fresh Frozen Plasma, Leukocytes Reduced
  • Plasma for Plasma Frozen Within 24 Hours After Phlebotomy (PF24) and Plasma Frozen Within 24 Hours After Phlebotomy, Leukocytes Reduced
  • Plasma for Plasma Frozen Within 24 Hours After Phlebotomy Held At Room Temperature Up To 24 Hours After Phlebotomy (PF24RT24) and Plasma Frozen Within 24 Hours After Phlebotomy Held At Room Temperature Up To 24 Hours After Phlebotomy, Leukocytes Reduced
  • Source Plasma

Storage of RBCs Collected on the Trima Accel system
  • Adequate studies have not been performed to evaluate the effect of gamma irradiation or freezing on the quality of ACD-A/AS-3 red blood cell products (RBCs) collected with gravity drain leukoreduction process (TLR filter) on the Trima Accel system.
  • Studies have not been performed to support gamma irradiation or freezing of ACD-A/AS-3 RBCs collected with an integrated in-line RBC leukoreduction filter(s) (Auto RBC filter) on the Trima Accel system.

Storage of Platelets Collected on the Trima Accel system
  • Platelets Pheresis may be manufactured from products that do not meet leukocyte reduction product standards. Platelets Pheresis, Leukocytes Reduced, Platelet Additive Solution (Isoplate or InterSol) may be further process (e.g., irradiated, divided). Platelets Pheresis, Platelet Additive Solution (Isoplate or InterSol) may not be manufactured from products that do not meet leukocyte reduction product standards.

  • The storage conditions of the Trima Platelet bag (ELP bag) have been verified for storage up to 7 days post-collection in 100% Plasma and up to 5 days in Isoplate (PAS-F) or InterSol (PAS-C) solutions.
  • Additionally, for storage up to 7 days, every product must be tested with a bacterial detection device cleared by FDA and labeled as a “safety measure.”
  • The Trima Blood Component Sampling Assembly, which is either integrated into the disposable tubing sets or available as an accessory for sterile connection, is intended to allow aseptic removal of a sample from the platelet bag for subsequent bacterial or other applicable testing. The Sampling Assembly does not have contact with blood fluids that are reinfused to a donor or patient.

Storage of Plasma Collected on the Trima Accel system
  • Fresh Frozen Plasma and Fresh Frozen Plasma, Leukocyte Reduced must be prepared and placed in a freezer at -18 °C or colder within 8 hours of phlebotomy.
  • Plasma Frozen Within 24 Hours After Phlebotomy (PF24) and Plasma Frozen Within 24 Hours After Phlebotomy, Leukocytes Reduced must be stored at 1 °C to 6 °C within 8 hours of phlebotomy and placed in a freezer at -18 °C or colder within 24 hours of phlebotomy and is indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.
  • Plasma Frozen Within 24 Hours After Phlebotomy Held At Room Temperature Up To 24 Hours After Phlebotomy (PF24RT24) and Plasma Frozen Within 24 Hours After Phlebotomy Held At Room Temperature Up To 24 Hours After Phlebotomy, Leukocyte Reduced can be stored at room temperature for up to 24 hours after phlebotomy. Product must be placed in a freezer at -18 °C or colder within 24 hours of phlebotomy and is indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.

Rx only.
BK190332/0 Terumo BCT, Inc
10811 W. Collins Avenue,
Lakewood, CO 80215-4415
05/22/2019
NBM-200 Pulse Oximeter and Hemoglobin Monitor
Hemoglobin for donor testing
The NBM-200 is a portable Hemoglobin and oximetry monitor. It non-invasively spot checks and displays Hemoglobin (Hb), estimated Hematocrit (Hct) values, functional saturation of arterial oxygen hemoglobin (SpO2), and pulse rate (PR). These parameters can be displayed periodically for patient monitoring.

The monitor estimates Hct via a calculation based on the Hb measurement for normal hemoglobin values (11 to 17 g/dl) only and abnormal values will not be displayed. It is intended for use by trained medical personnel, with adult individuals, in non-critical clinical and non-clinical settings, e.g., non-critical settings in hospitals, hospital-type facilities, blood donation settings, mobile environments, clinics, physician offices and ambulatory surgery centers. In this context, non-critical means patient examination settings where continuous monitoring is unnecessary. Non-critical environments exclude, for example, intensive care units.
BK190322/0 OrSense Ltd
Covington & Burling LLP
One City Center,
850 Tenth Street, NW
Washington, DC 20001-4956
05/09/2019
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