Vaccines, Blood & Biologics

2018 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.

2018 Biological Device Application Approvals
Tradename/Common NameDescription and Indication for DeviceSubmission IDManufacturerClearance Date
Biowy Freezing Bag
Frozen Donor Tissue Storage Container
The Biowy Freezing Bags are intended for a single sequence of freezing, storage (in Liquid Nitrogen (-196 Celsius) and subsequent thawing (at +37 Celsius) of hematopoietic progenitor cells.BK170150/0Biowy Corporation
27031 Vista Terrace
Lake Forest, California 92630
5/11/2018
Thrombinator System for use with the Arthrex Angel concentrated Platelet Rich Plasma (PRP) System
Platelet And Plasma Separator for Bone Graft Handling
The Arthrex Angel concentrated Platelet Rich Plasma (cPRP) System is designed to be used in the clinical laboratory or intraoperatively at the point of care for the safe and rapid preparation of platelet poor plasma and platelet concentrate (platelet rich plasma) from a small sample of whole blood or a small mixture of blood and bone marrow. The platelet rich plasma can be mixed with autograft and/or allograft bone prior to application to an orthopedic site. The Thrombinator System for use with the Arthrex Angel concentrated Platelet Rich Plasma (cPRP) System is designed for the preparation of autologous serum from anticoagulated peripheral blood or platelet poor plasma that is to be mixed with PRP and autograft or allograft bone prior to application to a bony defect for improving handling characteristics.BK170144/0Arthrex, Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945
5/10/2018
TANGO Infinity Software Version 1.5
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 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 Erytpe S agglutination metholodology 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, 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 in training.
BK180175/0Bio-Rad Medical Diagnostics GmbH
Industriestrasse 1,
63303 Dreieich, Germany
5/1/2018
IH-Com V5.0
Automated Blood Grouping and Antibody Test Systems
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 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 IH-1000, with multiple IH-1000 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 V5.0 is “Rx only”.
BK180174/0Bio-Rad Medical Diagnostics GmbH
Industriestrasse 1,
63303 Dreieich, Germany
5/1/2018
PCS 300 Plasma Collection System (Software Version 1.2.0)
Automated Blood Cell Separators
The PCS 300 Plasma Collection System is intended for use as an automated cell separator system and blood component collector in conjunction with single-use sterile disposable sets, with or without saline compensation. Products that can be collected using the PCS 300 system include source plasma and plasma for transfusion.BK180185/0Haemonetics Corporation
400 Wood Road
Braintree, MA 02184
3/27/2018
Neg Control
Quality Control Kits for Blood Banking Reagents
Neg Control is used as a negative control in conjunction with DIAGAST monoclonal Anti-D reagents (210524-210525-210526).BK160084/0DIAGAST
Parc Eurasanté 251, Avenue Eugéne BP 9, LOOS Cedex,
France 59374
2/2/2018
BacT/ALERT® BPA Culture Bottle
Bacterial Detection Systems for Platelet Transfusion Products

BacT/ALERT® BPA culture bottles are used with the BacT/ALERT®Microbial Detection Systems for quality control testing of leukocyte reduced apheresis platelet (LRAP) units, and both leukocyte reduced single and a pool of up to six (6) units of leukocyte reduced whole blood platelet concentrates (LRWBPC). BacT/ALERT BPA culture bottles support the growth of aerobic microorganisms (bacteria and fungi). BacT/ALERT® BPN culture bottle are used with the BacT/ALERT®Microbial Detection Systems for quality control testing of leukocyte reduced apheresis platelet (LRAP) units, and both leukocyte reduced single and a pool of up to six (6) units of leukocyte reduced whole blood platelet concentrates (LRWBPC). BacT/ALERT BPA culture bottles support the growth of aerobic and facultative anaerobic microorganisms (bacteria).

BacT/ALERT Microbial Detection Systems and culture bottles may be used for quality control testing of platelets and as a secondary safety measure test. Bacterial tests are labeled as safety measure when they show benefit for detection of bacterial contamination not revealed by previous bacterial testing. The laboratory should follow its own quality control procedures for these uses.

BK170142/0BioMerieux, Inc.
595 Anglum Road
Hazelwood, MO 63042
2/1/2018
EVICEL™ Laparoscopic Airless Spray Accessory (35 cm Rigid)
Fibrin Sealant Preparation Device
The EVICEL™ Laparoscopic Airless Spray Accessory (35 cm Rigid) is intended to be used with the EVICEL™ Application Device for the simultaneous topical application of the two biological components of EVICEL® Fibrin Sealant (Human) onto the surface.BK170138/0ETHICON Inc.
Route 22 West
Somerville, New Jersey 08876
1/26/2018
UltraCW®II Automatic Cell Washing System
Automated cell-washing centrifuge for immune-hematology

The UltraCW®II Automatic Cell Washing System is intended to be used for the washing portion of routine blood bank and laboratory procedures calling for washed red blood cells such as antiglobulin testing, ABO compatibility, Rh, cross matching and anti-body screening.

The UltraCW®II Automatic Cell Washing System should be operated by a trained individual such as a clinical laboratory technologist or similar education as determining whether desired results have been achieved is subjective and is dependent upon user preparation of blood sample, and parameter selection/adjustment.

BK170141/0Helmer Inc.
14400 Bergen Boulevard
Nobelsville, IN 46060
1/22/2018
Procleix Xpress® System (Software v3.0)
Automated blood grouping and antibody test system
The Procleix Xpress® System (Software and Instrument) is intended to be used to create pools of human plasma or serum for blood screening tests for viral nucleic acids. The Procleix Xpress® System automatically transfers plasma or serum from individual samples into a single master pool tube, which may be used for further testing in Procleix® systems. The Procleix Xpress® System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the Procleix Xpress® System can be used to dispense human plasma or serum aliquots into an archive plate.BK170162/0Grifols Diagnostic Solutions Inc.
4560 Horton Street
Emeryville, CA 94608
1/18/2018
Cyclone Blood & Bone Marrow Concentration (BBMC) System
Platelet And Plasma Separator For Bone Graft Handling
The Cyclone Blood BBMC System is designed to be used intraoperatively at the point of care for the safe and rapid preparation of a platelet concentrate (platelet rich plasma or PRP) from a small sample of a mixture of peripheral blood and bone marrow. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improved handling characteristics.BK170108/0Alliance Partners LLC
14206 Northbrook Drive
San Antonio, TX 78232
1/2/2018

 

Page Last Updated: 06/13/2018
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