One Lambda Inc, Canoga Park, Calif, now part of Thermo Fisher Scientific, a producer of medical diagnostic products for the HLA transplant community, reports the FDA has cleared its HLA Fusion Software version 3.0, a companion software to molecular typing and antibody screening products.
All of One Lambda software products are designed to assist personnel experienced in HLA analysis by suggesting typing and antibody screening results. Product families used in conjunction with HLA Fusion include LABScreen® (antibody detection) and LABType® (HLA Typing) products, in addition to LAT™, LCT™, FlowPRA®, and MicroSSP™ products.
The HLA Fusion Software version 3.0 provides all the tools and applications from version 2.0 and its related Service Packs, support with Luminex® xPONENT® 3.1 acquisition software for LABScan® 100, and more.
Limitations: All One Lambda software products are designed to assist personnel experienced in HLA analysis by suggesting typing results. However, any clinical or diagnostic results must be carefully reviewed by a person qualified in HLA typing to assure correctness. This software may be used to aid in suggesting results, but should not be used as the sole method for determining reportable results. This software is meant as a laboratory aid, not as a source of definitive results. The software design does not mitigate hazards associated with the software. The laboratory director or technologist trained in histocompatibility testing is required to review all data to detect any problems with the software.
[Source; One Lambda Inc]
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