Substantially Equivalent 510(k) Device Information
Applicant: One Lambda, Inc., Canoga Park, CA
510(k) number: BK980015
Product: FlowPRA
Date: 7/23/99
Summary of Safety and Effectiveness
APRIL 21, 1998
Claiming equivalence to:
Lambda Cell Tray - BK840013
Description of the Device
The FlowPRA Screening Test is designed for flow cytometric screening of panel reactive antibody (PRA) against HLA using a panel of FlowPRA beads, which are microparticles (2-4µm in diameter) coated with purified HLA antigens.
Intended Use
The FlowPRA Screening Test is intended for use in flow cytometric detection of
HLA-specific antibodies in serum.
Summary of Substantial equivalence
FlowPRA and LCT is intended to detect the presence of HLA antibodies in a
serum sample. The mechanism for attachment is the same. The HLA antibody
will attach to the complementary antigen of a HLA specificity. In the case of the
FlowPRA the HLA antigen is attached to the bead and in the case of the LCT the
antigen is attached to the lymphocyte. The detection method is different.
FlowPRA will detect the attached antibody with the use of a Flow Cytometer and
the LCT by use of the microcytotoxicity test. The data received in both cases will
be used to calculate the % PRA for the serum sample.
The methodology of detecting the HLA antigen and antibody attachment is
different but the ending results are the same, % PRA.
Summary of Intended Use as compared to the predicate device
The FlowPRA Screening Test has the same name intended us as the Lambda Cell Tray
(LCT) which is to determine the presence of HLA antibodies in human serum.
Both tests have 30 cells (bead) panel. Both tests can determine the percent PRA (%PRA). Studies showed a good correlation between the two tests on the % PRA detected from randomly selected patient sera.
Summary of Comparison between FlowPRA and LCT
Comparison of the FlowPRA test to the marketed LCT tests is listed in Table 1
And 2 which showed R values of over 80%.
Summary of Technological Characteristics
The technology of FlowPRA utilizes flow cytometry based technique for HLA
antibodies detection and obtains statistically similar results as the predicted device LCT. This test utilizes a flow cytometer for data analysis. We have compared
different flow cytometers in different laboratories which all gives comparable results.
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