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Biofortuna obtains FDA 510(k) approval for SSPGo HLA PCR kits

UK-based Biofortuna has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its line of SSPGo HLA PCR kits, designed for transplantation genotyping and identification of genes that may be associated with various genetic conditions.

Biofortuna’s SSPGo HLA typing kits are qualitative DNA-based kits for determining HLA alleles in low to intermediate resolution.

According to the company, its freeze dried kits contain everything required for PCR, including Taqpolymerase. These kits are stable at ambient temperature and convenient, only requiring the end user to add DNA to a freeze dried PCR mix prior to amplification and detection.

The kits can be stored and transported at ambient temperature, eliminating the need for refrigerators, freezers and temperature controlled shipping. Additionally, the kits may help to provide cost savings to the end user performing conventional HLA testing by helping reduce labor, consumables and the potential for pipetting error and contamination.

Biofortuna CEO Dr Simon Douglas noted the company is delighted that it has received FDA clearance of its SSPGo kits.

"This significant milestone will allow our partner, Abbott, to distribute the world’s first freeze dried HLA typing kits in the US," Dr Douglas added.

Biofortuna and Abbott have announced an exclusive global distribution agreement in 2011 for the SSPGo kits. Until now, the kits were CE marked and only distributed in Europe and Asia Pacific. With the FDA 510(k) approval, the kits will be available in early 2014 in the US.