129-P: DEVELOPMENT OF THE FIRST FDA 510(K) CLEARED DNA SEQUENCING SYSTEM

Aim To provide an IVD cleared HLA sequence based typing system Life Technologies developed a 510(k) system submission including the 3500 Dx Genetic Analyzer, 3500 Dx Data Collection Software, the Veriti™ Dx Thermal Cycler, SeCore® HLA SBT kits, and uTYPE® Dx HLA SBT Analysis Software (SeCore system). Two external clinical studies were performed to demonstrate SeCore® system accuracy and reproducibility. Methods The first clinical trial focused on HLA typing concordance across 3 independent clinical laboratories. The sites selected 300 samples for comparison of the SeCore® system results to the predicate device SSP Unitray® Direct to High Res. The second external study evaluated system reproducibility, where 3 laboratories ran the same “known” samples. The samples were run 6 times over 6 non-consecutive days by 2 operators with each SeCore® kit. Results For the comparative study, the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method for each kit. The lower confidence limit was greater than 0.95 for all kits for study success. Actual concordance was >97% for all kits. Each clinical site identified at least 1 potential novel allele in their sample set. Out of 299 samples tested, 11 were discordant to the predicate device. New alleles were identified in HLA-B, -C, -DRB4, and HLA-DPB1. The reproducibility study concordance rate was calculated using the same method as described in the comparative study. The actual concordance rate was 100% for all sites with no instances of discordance. The study also demonstrated reproducibility of uTYPE® Dx software allele pairs within the results list and recommended group specific sequencing primers (GSSPs). Conclusions The results for the SeCore® system met the acceptance criteria of at least 95% concordance with 90% confidence for all Class I and Class II loci and GSSPs demonstrating system accuracy and reproducibility. Agostini: Life Technologies: Employee. Shi: Life Technologies: Employee. Kashi: Life Technologies: Other: Study Site Participant. Noreen: Life Technologies: Other: Study Site Participant. Davidson: Life Technologies: Other: Study Site Participant. Tambur: Life Technologies: Other: Study Site Participant. Williams: Life Technologies: Other: Study Site Participant. Wu: Life Technologies: Other: Study Site Participant. Dinauer: Life Technologies: Employee.