LEUKOSEP® Filtration System
The LEUKOSEP® HRC-600-C Leukocyte Reduction Filtration System for Red Blood Cells is a single use device which reduces leukocytes from a single unit of CPD/AS-1 Red Blood Cells prior to long term storage. The fluid pathway is sterile and non-pyrogenic. The LEUKOSEP® System includes a leukocyte reduction filter, red blood cell storage container, associated tubing, clamps and connector.
System Advantages
- Easy, one-step process: Simply Hang It — and Walk Away™
- No operator intervention required
- No vents, caps or check valves
- No burping or stripping
- No clamps to attend to during the filtration process
- Auto-draining system
- Self-priming filter
- True closed system
Clinical Testing
The LEUKOSEP® System met new stringent regulatory criteria for in vitro and in vivo clinical testing:
A one-sided 95% lower confidence limit for the true proportion of units with a:
- Filtration recovery of red blood cell mass of at least 85% is greater than 95%.
- Residual leukocyte content of less than 5 x 106 per unit is greater than 95%.
- Hemolysis at end of storage of less than 1% is greater than 95%.
Mean 24-hour post transfusion, in vivo red cell recovery at end of storage of at least 75% with standard deviation of at most 9%, and the lower limit of a one-sided 95% confidence interval for the population proportion of successes is 70% or greater. Success is defined as a subject that has at least 75% in vivo 24-hour recovery.
In vivo Clinical Results
LEUKOSEP® System In vivo 24-hour Radiolabeled Red Blood Cell Recovery Study
(Double Label 51Cr/99mTc Method)
During clinical studies conducted at three U.S. sites, 24 out of 24 subjects (24/24) demonstrated in vivo 24 hour red blood cell recovery at end of storage of ≥75%.
Indications for Use:
The LEUKOSEP® HRC-600-C Leukocyte Reduction Filtration System for Red Blood Cells is indicated for pre-storage leukoreduction of a single unit of CPD/AS-1 Red Blood Cells.
- AS-1 Red Blood Cells processed and filtered at room temperature within 8 hours after blood collection, then stored as AS-1 Red Blood Cells, Leukocytes Reduced at 1-6 °C within 8 hours.
- Whole blood stored at 1-6 °C within 8 hours after blood collection. Red Blood Cells prepared and AS-1 added within 48 hours of collection. Leukocyte Reduction filtration initiated no later than Day 3 after collection.
Filtered Red Blood Cells may be stored for a period appropriate for the anticoagulant and preservative solutions used.
Caution: Federal Law (US) restricts this device to sale by or on the order of a physician or properly licensed practitioner. Refer to Instructions for Use for indications, contraindications, warnings and precautions.