U.S. flag An official website of the United States government
  1. Home
  2. Vaccines, Blood & Biologics
  3. Development & Approval Process (CBER)
  4. 2016 Biological Device Application Approvals
  1. Development & Approval Process (CBER)

2016 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.

2016 Biological Device Application Approvals
Tradename/Common Name Description and Indication for Device Submission ID Manufacturer Clearance Date
Trima Accel Automated Blood Collection System
Automated Blood Cell Separators
The Trima Accel system is an automated blood component collection system that uses centrifugal force to separate whole blood into platelet, plasma, and red blood cell components These blood components are either collected into storage bags, or returned to the donor depending on the procedure selected at the time of collection. BK160116/0 TERUMO BCT
10811 W. Collins Ave,
Lakewood, CO, 80215
12/23/2016
Aptima HIV-1 Quant assay
HIV Detection Test
The Aptima HIV-1 Quant Dx assay is an in vitro nucleic acid amplification test (NAA T) for the quantitation of human immunodeficiency virus type 1 (HIV-1) RNA in human plasma from HIV-1 infected individuals on the fully automated Panther system. The Aptima HIV-I Quant assay quantitates HIV-1 RNA groups M, N, and 0 over the range of 30 to 10,000,000 copies/mL. One international unit is equivalent to 0.35 copies of HIV-1 RNA for the 3rd HIV-1 WHO International Standard (subtype B, NIBSC code: 10/152). Aptima HIV-1 Quant assay is intended for use in conjunction with clinical presentation and other laboratory markers for disease prognosis and for use as an aid in monitoring the effects of antiretroviral treatment, as measured by changes in plasma HIV-1 RNA levels. This assay is not intended to be used as a donor screening test for HIV-1 or as a diagnostic test to confirm the presence of HIV-1 infection. BP150318/0 Hologic, Inc.
10210 Genetic Center Drive,
San Diego, CA, 92121
12/22/2016
TSCD®-II Sterile Tubing Welder with or without Trucise Total System™
Transfer Sets
TSCD-II is used to connect two closed internally sterile components such as a blood collection container, apheresis set, transfer set or needle set by making a sterile weld in the tubing connected to these components. These welds may consist of dry-to-dry, wet-to-wet, or wet-to-dry conditions. The resulting sterile component may be used in blood collection, blood component processing or transfusion applications. The TSCD®-II device is not to be used with tubing connected to a person. BK160108/0 Terumo BCT, Inc
10811 W. Collins Ave.,
Lakewood, CO, 80215
11/23/2016
Automated Plasma Dispositioning System (APDS) Version 2.0
Blood Establishment Computer Software and Accessories
The Automated Plasma Dispositioning System (APDS) is used to receive, analyze, and store data for human plasma collected and shipped between facilities such as collection sites, warehouses and fractionation facilities. The system tracks data received from suppliers, verifying each plasma units’ suitability for further manufacture. The verification criteria are entered into the system through file and/or data transfers. BK160103/0 BioLife Plasma Services L.P. - Baxalta US Inc
440 N. Fairway Drive, 2W - 141,
Vernon Hills, IL, 60061
11/15/2016
DG Gel 8 Neutral
Automated Blood Grouping and Antibody Test Systems
The DG Gel 8 Neutral card is for the detection of antibodies to red blood cell antigens of human blood samples and for its use as a control microtube. For use with the DG Gel System. For in vitro diagnostic use. BK160100/0 Diagnostic Grifols, S. A.
Passeig Fluvial, 24,
Parets Del Valles, SP
11/9/2016
Cyclone® Platelet Rich Plasma (PRP) Concentrating System
Platelet and Plasma Separator for Bone Graft Handling
The Cyclone® Platelet Rich Plasma (PRP) Concentrating System is designed 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 application to a bony defect for improving handling characteristics. BK160045/0 Alliance Partners LLC
14206 Northbrook Drive,
San Antonio, TX, 78232
11/4/2016

ORTHO VISIONTMMax Analyzer

Automated Blood Grouping and Antibody Test Systems

ORTHO VISIONTM Max Analyzer is an instrument designed to automate in vitro immunohematology testing of human blood utilizing ID-MTSTM gel card technology. ORTHO VISIONTM  Max Analyzer automates test processing functions including liquid pipetting, reagent handling, incubation, centrifugation, reaction grading and interpretation and data management requirements using cards and digital image processing. ORTHO VISIONTM  Max Analyzer can be used as a standalone instrument or interfaced to the customer’s Laboratory Information System (LIS).

BK160058/0

Ortho-Clinical Diagnostics, Inc.

1001 U.S. Highway 202, Raritan, NJ 08869

10/21/2016

MTSTMBuffered Gel Card

Automated Blood Grouping and Antibody Test Systems

For the detection of antibodies to red blood cells; for in vitro diagnostic use only; for use with the ID-Micro Typing SystemTM.

BK160061/0

Micro Typing Systems Inc.

1295 S.W. 29th Ave., Pompano Beach, FL 33069

10/21/2016

IH-1000

Automated Blood Grouping and Antibody Test Systems

The IH-1000 is designed for Blood Grouping Determination using the IH-Cards, utilizing hemagglutination and gel filtration as principle of operation.
The instrument is intended to perform the detection of ABO, RhD (including weak D and partial D testing), Rh Pheno and Kell blood grouping for patient and donor samples as well as detection and indication of clinically relevant antibodies, cross matching and Direct Antiglobulin testing using the IH System reagents. The instrument generates results from individual images that must be verified by visual inspection and edited by a qualified operator.

BK140106/0

Bio-Rad Medical Diagnostics GmbH

Industriestrasse 1,
D-63303 Dreieich
Germany

10/20/2016

IH-COM

Automated Blood Grouping and Antibody Test Systems

IH-COM is a software package intended to be used as an interface between automated blood banking instruments and the Blood Establishment Computer Software. IH-Com is for use by trained laboratory personnel, in a blood banking environment, to assist with result interpretation, data management, and instrument control.

BK140107/0

Bio-Rad Medical Diagnostics GmbH

Industriestrasse 1,
D-63303 Dreieich
Germany

10/20/2016

IH-Card Neutral

Automated Blood Grouping and Antibody Test Systems

For serum grouping to be used with IH-Cell A2 on the IH-1000 Analyzer.

BK140138/0

Bio-Rad Medical Diagnostics GmbH

Industriestrasse 1,
D-63303 Dreieich

Germany

10/20/2016

IH-Card Control

Quality Control Kits for Blood Banking Reagents

IH-Card Control is intended for use as a supplemental control for IH-Cards with monoclonal Blood Grouping Reagents on the IH-1000 Analyzer.

BK140139/0

Bio-Rad Medical Diagnostics GmbH

Industriestrasse 1,
D-63303 Dreieich

Germany

10/20/2016

Cobas ®  8800 System and cobas p 68O Instrumnet

Automated Bloodborne Pathogen Test Equipment

The cobas® 8800 System supports an automated and integrated workflow to run Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) to be applied in blood screening laboratories. The cobas® 8800 System combines the functionalities of instrumentation, consumables, reagents, and data management to provide an efficient workflow from sample processing to result interpretation.

BK140195/0

Roche Molecular Systems, Inc.

4300 Hacienda Drive, Pleasanton, CA  94588

10/20/2016

cobas ®  6800 System and cobas p 68O Instrument

Automated Bloodborne Pathogen Test Equipment

The cobas® 6800 System supports an automated and integrated workflow to run Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) to be applied in blood screening laboratories. The cobas® 6800 System combines the functionalities of instrumentation, consumables, reagents, and data management to provide an efficient workflow from sample processing to result interpretation.

BK140196/0

Roche Molecular Systems, Inc.

4300 Hacienda Drive, Pleasanton, CA  94588

10/20/2016

Origen Transfer Bag

Empty Containers for the Collection & Processing of Blood/Blood Components

Origen Transfer Bag is intended for the processing of blood and blood components. For single-use only.

BK140116/0

OriGen BioMedical

Building D,
7000 Burleson Road, Austin, TX  78744

10/19/2016

Thermo Scientific CW3 Cell Washer

Automated Cell-Washing Centrifuge for Immunohematology

The Thermo Scientific CW3 cell washer is designed to perform blood cell washing in multiple washing cycles using saline solution.
The cell washer provides blood cells after sample separation, which can be used for further blood testing such as anti-globulin test, ABO compatibility, Rh testing, Cross matching and Antibody screening.

BK160044/0

Thermo Electron LED GmbH (a subsidiary of Thermo Fisher Scientific Inc.)

Am Kalkberg,
37520 Osterode am Harz

Germany

10/7/2016

ADVIA Centaur® HIV Ag/Ab Combo (CHIV) Assay

HIV Detection Test

This device is indicated for the simultaneous qualitative detection of human immunodeficiency virus p24 antigen and antibodies to human immunodeficiency viruses type 1 (including group “O”) and type 2, in serum and plasma (potassium EDTA, lithium heparin, sodium heparin), using the ADVIA Centaur and DAVIA Centaur XP sytems. The ADVIA Centaur CHIV assay is intended to be used as an aid in the diagnosis of HIV infection in pediatric and adult populations, including pregnant women.

BP140103/3

Siemens Healthcare Diagnostics, Inc.

511 Benedict Ave, Tarrytown, NY 10591

10/19/2016

HCLL™ Transfusion 2015 R2
Blood Establishment Computer Software and Accessories
HCLL™ Transfusion 2015 R2 is intended to address all phases of transfusion services activities, and assists transfusion service personnel:
  • Manipulate and label products
  • Print ISBT 128 blood labels
  • Perform electronic cross match
  • Issue blood products under normal and emergency conditions
  • Receive and test patient and unit specimens
  • Interface to blood bank testing instruments (bi-directional)
  • Interface to blood storage device (bi-directional)
BK160066/0 Mediware Information Systems, Inc.
11711 W 79th Street,
Lenexa, KS, 66214
9/30/2016
Aurora Xi Plasmapheresis System
Automated Blood Cell Separators
The Aurora Xi Plasmapheresis system is intended for the automated collection of plasma by membrane filtration to be processed as Source Plasma. The Aurora Xi system is to be used with a single-use PLASMACELL Xi disposable set and 4% sodium citrate anticoagulant, and allows for Saline and No Saline Protocol options. BK160028/0 Fresenius Kabi AG
Three Corporate Dr,
Lake Zurich, IL, 60047
9/21/2016
BD FACSVia™ System with the BD Leucocount reagent Assay
Automated differential Cell Counter
BD FACSVia™ Flow Cytometer System Functions with dedicated BD FACSVia™ clinical software using a blue laser (488 nm) with two fluorescent detection channels (FL1 for BD Trucount™ Tube and FL2 for the BD Leucocount™ reagent). The system is intended for flow cytometric enumeration of residual white blood cells (rWBCs) in leucoreduced blood products with the following reagents and controls:
  • The BD Leucocount™ Kit
    Consists of Leucocount reagent (propidium iodide fluorescent dye) and Trucount tubes and is intended for enumerating residual white blood cells (rWBCs) in leucoreduced blood products.
  • The BD Leucocount™ RBC Control Kit
    Consists of Red Blood Cells (RBC) Low and RBC High process controls intended for use with the BD Leucocount Kit to monitor the process for enumeration of residual leucocytes in leucoreduced RBC products including dilution, staining, instrument set up and white blood cell (WBC) enumeration.
  • The BD Leucocount™ PLT Control Kit
    Consists of Platelet (PLT) Low and PLC High process controls intended for use with the BD Leucocount Kit to monitor the process for enumeration of residual leucocytes in leucoreduced Platelet products including dilution, staining, instrument set up and white blood cell (WBC) enumeration.
  • The BD™ CS&T Beads
    For verification of optical and fluidic performance and to adjust compensation on the flow cytometer. For in vitro diagnostic use.
  • BD Leucocount™ Kit
    Consists of Leucocount reagent (propidium iodide fluorescent dye) and Trucount tubes and is intended for use with the BD FACSCalibur™, BD FACSort™, BD FACScan™, and BD FACSVia™ flow cytometer systems, or for a flow cytometer equipped with a 488 nm argon-ion laser able to threshold on FL2, for enumerating residual white blood cells (rWBCs) in leucoreduced blood products. For in vitro diagnostic use.
BK150307/0 BD Biosciences
2350 Qume Drive,
San Jose, CA, 95131
9/16/2016
InstaMatch 1.0.0
Blood Establishment Computer Software and Accessories
InstaMatch is a configurable, web-based software tool used by medical professionals at Donor Centers and/or Hospital/Transfusion facilities. InstaMatch provides searching and matching capabilities for patients, donors and blood products that possess specific attributes or characteristics, such as human leukocyte antigens (HLA), ABO/Rh, CMV status, and antibodies. InstaMatch provides the following functionalities:
  • interfaces with Blood Establishment Computer Software ( BECS).
  • finds compatible blood products and donors in the BECS database based on attributes such as HLA information.
  • provides donor and/or product details after a search is performed.
  • calculates a grade and site-configurable score indicative of HLA compatibility between donor, product, and patient.
BK160052/0 Haemonetics Corporation
4925 Robert J Mathews Parkway,
El Dorado Hills, CA 95762
8/25/2016
Donor-ID 3.2 integrated with iCASI App Android
Blood Establishment Computer Software and Accessories
Donor-ID is a computer system to be used by trained blood center staff to manage donors throughout the blood donation process and to collect and record data. Through the use of computers communicating in real time to the system as it runs on a server, the data obtained for input include: donor demographic data; responses to health history questions (direct oral questioning with optional CASI) and follow up documentation; physical exam results; the phlebotomy data; and donor signature. Optional Computer Assisted Self Interview (CASI) provides the donor with the opportunity to respond to the health history questions 1) at the collection site; or 2) from an external computer accessing the blood center’s controlled and secure intranet resulting in a printed document with bar codes that is used upon presentation by the specific donor at the collection site to input the data provided by the donor and to confirm the date. All donor responses through CASI are reviewed by a blood center employee.

Donor-IDTM 3.2 is also integrated with iCASI App iOS/Android technology for use with the donor questionnaire. This is an optional feature.

BK160039/0 Healthcare-ID, Inc.
1635 Barclay Blvd.,
Buffalo Grove, IL, 60089
7/28/2016
Briostor Transfer/Freezing Bag Set
Cord blood processing system and storage container
The Pall Briostor Transfer/Freezing Bag Set is indicated for use for cord blood processing and freezing. BK150314/0 Pall Corporation
25 Harbor Park Drive,
Port Washington, NY 11050
6/16/2016
Bone Marrow Collection Kit and Stand
Bone Marrow Collection Kit and Accessories
The Bone Marrow Collection Kit, Ancillary Container and Bone Marrow Collection Stand are used for the collection and filtration of aspirated bone marrow in preparation for bone marrow transplantation. BK160042/0 Fresenius Kabi
Three Corporate Drive,
Lake Zurich, IL, 60047
6/9/2016
Aurora Plasmapheresis System, Software Version 1.3 Automated Blood Cell Separators

The Aurora Plasmapheresis System is an automated plasmapheresis system designed to collect virtually cell-free plasma by membrane filtration using single-use disposable sets. Collected plasma is to be processed as Source Plasma.

BK160012/0

Fresenius Kabi AG
Else-Kroner-Strasse 1, Bad Homburg, GM 61346

05/19/2016
ElDorado Donor 4 Next Generation Donor Management Solution 1.0.0 Blood Establishment Computer Software (BECS)

ElDorado Donor 4 Next Generation Donor Management Solution is intended for use in facilities and mobile environments to provide full traceability of blood components along with safety checks to prevent ineligible donors from donating and to prevent the release of unsafe blood components. The software can perform self/staff-assisted questionnaires and record donor questionnaire assessment results. ElDorado Donor 4 Next Generation Donor Management Solution can operate stand-alone or interface with:
• Donor Management Systems
• Labeling systems
• Test Lab systems
• Apheresis devices and collection equipment

BK160019/0

Haemonetics Corporation
4925 Robert J Mathews Parkway, El Dorado Hills, CA, 95762

05/17/2016

AcrodoseTM PL System
Containers, Empty, for the Collection & Processing of Blood/Blood Components

The AcrodoseTM PL System is indicated for pooling of ABO identical, leukocyte-reduced,
whole-blood-derived platelet concentrates and subsequent storage for up to 5 days after
blood collection when coupled with a device cleared by FDA for detection of bacterial contamination in pooled leukoreduced whole-blood-derived platelets.

The AcrodoseTM PL System should be used with whole-blood-derived platelet concentrates collected in CP2D anticoagulant and leukoreduced using the Leukotrap® RC PL or Leukotrap® PL Filtration Systems. Each CLX® HP extended storage bag can store 2.2 – 5.8 x 1011 platelets, from 4 to 6 platelet concentrates, at a platelet concentration of ≤ 2.3 x 106/μL, in a volume of 180 – 420 mL.


 

BK160027/0

Haemonetics Manufacturing Inc.
1630 Industrial Park Street, Covina, CA, 91722

05/16/2016

LIFECODES HLA-DQA1/B1 SSO Typing Kit;
LIFECODES HLA-DPA1/B1 SSO Typing Kit;

Qualitative Test for HLA, Non-diagnostic
LIFECODES HLA – SSO Typing Kits are qualitative tests for the DNA typing of Class I and Class II HLA alleles, to aid in transfusion and transplant donor and recipient matching. The source of material tested is DNA. The products are used by trained professionals in medical settings for the purpose of determining HLA phenotype. No component of the kit comes in direct contact with the patient. Potential donor/recipient DNA typing are not the sole tests upon which a clinical decision affecting the patient is based; a cross-match is routinely required prior to making a decision to transplant.. These kits are intended for In Vitro Diagnostic (IVD) use. BK150302/0

Immucor Transplant Diagnostics, Inc.
550 West Avenue, Stamford, CT, 06902

05/11/2016

LIFECODES MATCH IT!TM DNA Software v1.2Qualitative Test for HLA, Non-diagnostic

LIFECODES MATCH IT! DNA Software is an accessory to aid in the evaluation of test results from Immucor Transplant Diagnostics LIFECODES HLA SSO kits for use with Luminex. Due to the complex nature of HLA Testing, qualified laboratory personnel must review any result to assure correctness. BK150343/0

Immucor Transplant Diagnostics, Inc.
550 West Avenue, Stamford, CT, 06902

05/11/2016
ABO Express, Version 2.0.0
Blood Establishment Computer Software
ABO Express is intended to address all phases of donor and transfusion services. The software is designed to assist personnel in collection services, component laboratory, testing, shipping/receiving, transfusion services and reference laboratory. BK160011/0 Blood Bank Computer Systems, Inc.
1002 15th St. SW, Suite 120, Auburn, WA, 98001
4/26/2016
LIFECODES LifeScreen Deluxe (LMX)
HLA Antibody Assay
LIFECODES LifeScreen Deluxe is a qualitative bead-based immunoassay used to detect IgG antibodies to HLA Class I and Class II molecules. BK160035/0 Immucor GTI Diagnostics, Inc.
20925 Crossroads Circle, Waukesha, WI, 53186
4/21/2016
Amicus Separator System
Automated Blood Cell Separators (Centrifugal Separation Principle)
The AMICUS Separator System is an automated blood cell separator indicated to perform Therapeutic Plasma Exchange (TPE). The AMICUS Separator System is an automated blood cell separator indicated for the collection of blood components and mononuclear cells. The device is designed to collect products while maintaining an extracorporeal volume at or below 10.5 mL/kg and a donor post platelet count greater than or equal to 100,000 platelets/microliter.

Depending on the AMICUS Separator System apheresis kit used in the collection of products, the AMICUS Separator System has been cleared to collect:
  • Platelets Pheresis, Leukocytes Reduced (single, double, or triple units)
  • Platelets Pheresis, Leukocytes Reduced, Platelet Additive Solution (InterSol) (single, double or triple units)
  • Red Blood Cells, Leukocytes Reduced (by apheresis)
  • Mononuclear Cells
  • Plasma
    • Fresh Frozen Plasma
      • Must be prepared and placed in a freezer at -18°C or colder within 8 hours after phlebotomy.
    • 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.
    • Source Plasma
      Platelet Pheresis (single, double, or triple units) may be manufactured from products that do not meet leukocyte reduction product standards. This does not apply to Platelet Pheresis, Platelet Additive Solution (InterSol) (single, double, or triple units).


The AMICUS platelet storage container is cleared to store Platelets Pheresis, Leukocytes Reduced in 100% plasma for up to 7 days. Additionally, for platelet units stored past 5 days and through 7 days, every product must be tested with a bacterial detection device cleared by FDA and labeled as a “safety measure.” Prescription
BK150357/0 Fresenius Kabi USA LLC.
Three Corporate Drive, Lake Zurich, IL, 60047
4/20/2016
Integrated Blood Bank Information System (IBBIS), Version 4.0
IBBIS
IBBIS Version 4.0 is a computerized system of programs to aid in the entry, tracking, and lookback of information related to blood donor registration, donor eligibility determination (including a computer-assisted self-interview (CASI), technician review of donor responses, capture of donor physical results, automatic deferral creation), blood donation collection, blood product processing, labeling, and manipulation (e.g., fractionating, splitting, freezing, irradiating), product quarantine and release, product distribution (shipping and receiving), and donor testing, including the ability to electronically transfer testing results from an outside testing facility. While the majority of the programs within IBBIS v4.0 are intended to be used by trained blood bank personnel, the CASI functionality included in IBBIS v4.0 is intended to be used by donors at the collection site to respond to the health history questionnaire with or without assistance from blood bank personnel. BK160004/0 LifeSouth Community Blood Centers Inc.
4039 Newberry Road,
Gainesville, FL, 32607
3/29/2016
Apligraf
PFC
Apligraf is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full thickness skin ulcers due to venous insufficience of greater than one month duration and which have not adequately responded to conventional ulcer therapy. Apligraf is also indicated for use with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers of greater than three weeks duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure. BP953200/83 Organogenesis, Inc.
150 Dan Road,
Canton, MA, 02021
3/25/2016
Sunquest Blood Bank and Blood Donor, Version 8.0
Blood Establishment Computer Software
The Blood Bank is intended for use by trained healthcare professionals responsible for transfusion services. It is intended for use to:
  • Store records of manufactured and blood product component preparation.
  • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer.
  • Record the release of manufactured and blood products for infusion.
  • Maintain manufactured and blood product inventory for lookback.
  • Maintain a historical record of the patient’s blood bank and transfusion related data.
  • Record testing results of patient specimens and blood products either manually or through instrument interfaces.
  • Display data required to assist health care professionals when qualifying patients for electronic crossmatch.
Blood Donor is intended for use by trained health care professionals responsible for donor services. It is intended for use to:
  • Display data that assists health care professionals in making decisions regarding the suitability of donors.
  • Generate deferrals to the donor record and maintain donor records.
  • Maintain phlebotomy records.
BK160005/0 Sunquest Information Systems, Inc.
250 S. Williams Blvd.,
Tucson, AZ, 85711
3/25/2016
OraQuick ADVANCE Rapid HIV-1/2 Antibody Test
TEST, MONITOR,HIV
The OraQuick ADVANCE ® Rapid HIV-1/2 Antibody Test is a single-use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in oral fluid, fingerstick whole blood, venipuncture whole blood and plasma specimens. The OraQuick ADVANCE ® Rapid HIV-1/2 Antibody Test is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. BP010047/62 OraSure Technologies, Inc
220 East First Street,
Bethlehem, PA, 18015
3/23/2016
INTERCEPT Blood Systerm for Platelets
Preparation and storage of pathogen-reduced, blood components
The INTERCEPT Blood System for platelets is intended to be used for ex vivo preparation of pathogen-reduced apheresis platelet components in order to reduce the risk of transfusion-transmitted infection (TTI), including sepsis, and to potentially reduce the risk of transfusion-associated graft versus host disease (TA-GVHD). BP140143/8 Cerus Corporation
2550 Stanwell Drive,
Concord, CA, 94520
3/15/2016
SafeTrace Tx 3.12.0
Blood Establishment Computer Software (BECS)
SafeTrace Tx is an electronic information system that manages the blood transfusion process and assists in the determination of the suitability of released products. It manages and tracks blood product information relating to receipt, reservation, modification, testing (including reagent quality control), and final shipment and disposition. The application manages and provides a centralized view of patient, visit, and order information, including positive patient identification and patient, testing, and transfusion history. BK150360/0 Haemonetics Corporation
4925 Robert J Mathews Parkway, El Dorado Hills, CA, 95762
3/11/2016
Alere Determine HIV-1/2 Ag/Ab Combo
HIV Detection Test
HIV detection test BP120037/7 Alere Scarborough Inc
10 Southgate Road,
Scarborough, ME, 04074
3/4/2016
NextGen 3.0.0
Blood Establishment Computer Software (BECS)
NextGen 3.0.0 is an electronic information management system designed to undertake donation center operations including but not limited to recruitment of donors, screening of donors for suitability, immunizations, blood product collection processing, crossmatching, and providing lookback capabilities. NextGen manages donor information and allows multiple methods to identify donors, including biometrics such as fingerprints. NextGen is also designed to manage donor and product testing, labeling, barcode scanning, equipment, supplies, quality assurance, inventory, shipping, and product release. The NextGen questionnaire and phlebotomy functionalities can operate stand-alone. NextGen can interface with:
  • External donor management systems
  • Cross donation check systems
  • Apheresis devices
  • Screening test instruments
  • Test lab systems
  • Deferral registry systems
  • Other BECS systems
BK150330/0 Haemonetics Corporation Software Solutions
4925 Robert J. Matthews Parkway,
El Dorado Hills, CA, 95762
3/3/2016
3C Patch System
Peripheral blood processing device for wound management
3C Patch System is intended to be used at point of care for the safe and rapid preparation of platelet-rich plasma (PRP) gel from a small sample of a patient’s own peripheral blood. Under the supervision of a healthcare professional, the PRP gel produced by the 3C Patch System is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and mechanically or surgically-debrided wounds. BK140211/0 Reapplix Aps
Blokken 45,
3640 Birkerod, Denmark
2/24/2016
Lookback Notification System (LNS), Version 1.0
Stand alone Blood Bank Software
The Lookback Notification System is intended to generate and maintain electronic lookback records and allows for the automated creation, distribution and updating of applicable consignee notifications to assist in effectively identifying and removing unsuitable units (Source Plasma) at BioLife Plasma Services, prior to manufacturing. BK150347/0 BioLife Plasma Services L.P. - Baxalta US Inc
One Baxter Parkway, DF3-1E, Deerfield, IL, 60015
2/12/2016
COBAS AmpliPrep/COBAS TaqMan Wash Reagent, 5.1 L
HIV Detection Test
This test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 infected patients. The Test can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy by measuring changes in EDTA plasma HIV-1 RNA levels during the course of antiretroviral treatment. BP050069/73 Roche Molecular Systems, Inc.
4300 Hacienda Drive, Pleasanton,, CA, 94588
2/10/2016