"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92" on behalf of Alba Bioscience Limited.
Alba Bioscience Limited, 21 Ellen's Glen Road, Edinburgh EH17 7QT, Scotland, UK
Contact: Angela Robertson, Regulatory Affairs Manager Tel. +44 (0)131 5365994
Date prepared: July 29th, 2010
Name of Device: ALBAcyte® IgG Sensitized Red Blood Cells
510(k) Number: BK100005
Common Name: Quality Control for Routine Blood Bank Reagents
Classification: 21 CFR 864.9650, Class II
Classification Name: Quality Control for Blood Banking Reagents/KSF
Predicate Device: Biotest Coombscell-E
Device Description and Intended Use:
ALBAcyles® IgG Sensitized Red Blood Cells comprises 10mL reagent red blood cells prepared from at least four group O R1r blood donors sensitized using IgG antibody of anti-D specificity.
ALBAcyte® IgG Sensitized Red Blood Cells are for the control of the indirect antiglobulin test (IAT) and direct antiglobulin test (DAT).
Anti-Human Globulin (AHG) reacts with ALBAcyte® IgG Sensitized Red Blood Cells leading to agglutination of the red cells to demonstrate that the antiglobulin reagent has not been neutralised by residual IgG.
Comparison to Predicate Device:
A comparison between ALBAcyte® IgG Sensitized Red Blood Cells and the predicate device is presented in the table below. The devices are compared based on intended use, material and methodology.
|Parameter||ALBAcyte® IgG Sensitized Red Blood Cells 510(k) Number BK100005||Coombscell-E 510(k) Number BK080012|
|Intended Use||Control of the indirect antiglobulin test (IAT) and direct antiglobulin test (DAT).||Same|
|Principle/ Basis||Haemagglutination based on anti-IgG activity of the antihuman globulin reagent with the IgG sensitized control red blood cells||Same|
|Format||Liquid red cell suspension||Same|
|Methodology||Tube Agglutination Techniques||Same|
|Performance Parameters||A positive result indicates that the negative reaction achieved in the antiglobulin test is valid whereas any test which does not show a positive reaction should be considered invalid.||Same|
ALBAcytel® IgG Sensitized Red Blood Cells has the same intended use as the predicate device, Coombscell-E, the control of the indirect antiglobulin test (IAT) and direct antiglobulin test (DAT).
ALBAcyte® IgG Sensitized Red Blood Cells and Biotest Medical Diagnostics Coombscell-E both share the same methodologies. technological characteristics and performance parameters.
Summary of Clinical and Non-clinical Testing:
Clinical and non-clinical studies were performed to demonstrate Substantial Equivalence (SE) between ALBAcyt® IgG Sensitized Red Blood Cells and the US marketed predicate, Biotest Medical Diagnostics Coombscell E, 510(k) number BK080012.
In total 1,350 tests were performed covering both direct and indirect antiglobulin tests over four separate sites, one internal and 3 external including one located in the U.S. The study considered a number of test variables including manual versus automated washing and number of wash cycles, number of different operators, number of test days and the temperature of the IgG sensitised reagent red blood cells at the time of testing.
All tests gave negative reactions after centrifugation with anti-human globulin reagent and unequivocal positive reactions following addition of ALBAcyte® IgG Sensitised reagent red blood cells.
Testing was performed for three lots of Alba Bioscience ALBAcyte® IgG Sensitized Red Blood Cells in parallel with the predicate reagent Biotest Medical Diagnostics Coombscell E.
All tests were negative following incubation, washing and addition of AHG. All tests gave unequivocal positive reaction on reading following addition of IgG sensitized cells and centrifugation.
The results of comparator testing demonstrates that ALBAcyte® IgG Sensitized Red Blood Cells is substantially equivalent to Biotest Medical Diagnostics currently marketed predicate, Coombscell-E, 510(k) number BK080012. The methodologies and the intended use of these two devices are the same. The technological characteristics and performance parameters are the same for both reagents.
ALBAcyte® IgG Sensitized Red Blood Cells is as safe, as effective and is substantially equivalent to the legally marketed predicate device Biotest medical Diagnostics Coombscell-E.