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Final Response Memo, April 16, 2013 - SOLX® System



 
DEPARTMENT OF HEALTH AND HUMAN SERVICES                                         
                               

PUBLIC HEALTH SERVICE                                                            
                                                                                 
                                                                                 
                         

FOOD AND DRUG ADMINISTRATION                                                     
                                                   

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH                                     
     
Division of Biostatistics (HFM-215)

Statistical Review and Evaluation

                                                                                 
                        

Type/Application ID/Amendment #: NDA/BN 110059 

Subject: HEMERUS LEUKOSEP® HWB-600-XL Leukocyte Reduction Filtration System for 
Whole Blood with CPD Anticoagulant and SOLX® Additive

Applicant: Hemerus Medical, LLC

Indications for Use (Revised):        
The LEUKOSEP® HWB-600-XL Leukocyte Reduction Filtration System for Whole Blood 
with CPD Anticoagulant and SOLX® Additive also called “SOLX® System” is intended 
for the manufacture of: 
• CPD/AS-7 Red Blood Cells (RBC), Leukocytes Reduced prepared at ambient 
temperature and, placed at 1 to 6° C within 8 hours of collection. CPD/AS-7 Red 
Blood Cells, Leukocytes Reduced may be stored at 1 to 6° C for up to 42 days 
after collection.
• Fresh Frozen Plasma (FFP), Leukocytes Reduced prepared and placed in a freezer 
at -18° C or colder within 8 hours of collection. Fresh Frozen Plasma (FFP), 
Leukocytes Reduced may be stored at -18° C or colder for up to one year after 
collection.

Primary Statistical Reviewer:  Chinying Wang, Ph. D. (HFM-219)
Supervisory Concurrence:
1st Level Review
Supervisor Name: Tie-Hua Ng, Ph. D.
Supervisor Title: Team Leader, OBE/DB/TEB
Concur ______________ Not Concur ______________   
Supervisory Signature

2nd Level Review
Supervisor Name: Boguang Zhen, Ph.D. 
Supervisor Title: Branch Chief, OBE/DB/TEB 
Concur ______________ Not Concur ______________   
Supervisory Signature

Review Project Manager: Iliana Valencia (OBRR/DBA/RPMB) 

Cc: HFM-380/Xuan Chi, M. D., Ph. D. (OBRR/DH/LCH) 
HFM- 215 /Chronological File (OBE/DB) 
HFM-215/Estelle Russek-Cohen, Ph. D. (OBE/DB)
HFM-215/Boguang Zhen, Ph. D. (OBE/DB/TEB) 
HFM-215/John Scott, Ph. D. (OBE/DB)

Review SUMMARY
The study was conducted according to protocol PC387580, “In Vitro and In Vivo 
Evaluation of Hemerus LEUKOSEP® HWB-600-XL Leukocyte Reduction Filtration System 
for Whole Blood with CPD Anticoagulant and SOLX® Additive”. Based on the 
reported results, the clinical study showed that the primary endpoints of RBC 
mass recovery, leukorecution efficiency, hemolysis at end of storage, and 
24-hour radiolabeled recovery were met for all SOLX® RBC processing groups.

The updated statistical review memo was completed and concurred on August 28, 
2012. A Complete Response (CR) letter was issued on August 31, 2012. Hemerus 
submitted the responses to CR letter in the Amendment 15 dated February 26, 
2013. No statistical item was included in the CR letter.

Statistical Comment
There are no additional statistical comments for this supplement. 
 

    