YHLO Receives FDA 510(K) Clearance for iFlash 1800 Chemiluminescence Immunoassay Analyzer and iFlash Total βhCG Assay
YHLO Biotech announced today that the iFlash 1800 Chemiluminescence Immunoassay Analyzer and iFlash Total βhCG Assay have received a 510(k) clearance from the U.S. Food and Drug Administration through a local partner. A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent as predicate device. Receiving the 510(K) expands YHLO’s reach of iFlash 1800, as it has been installed in nearly 100 counties globally.
Using advanced acridinium ester-labeled chemiluminescence technology, YHLO iFlash 1800 is a bench-top solution tailored for small to medium sized laboratories. It is designed to have less outsourced samples, more in-house controlled quality and faster results output. The ingenious design of iFlash 1800 reduces the turn-around-time and analytical errors, which greatly optimizes the working flow and helps to save time for lab technicians.
YHLO iFlash Total βhCG Assay is a iFlash series analyzer applied test, measuring Total Beta Human Chorionic Gonadotropin (Total βhCG) levels, which can be helpful in identifying a normal or pathologic pregnancy throughout whole gestation period, following an aborted pregnancy and usefully indicating a variety of cancers including choriocarcinoma and extra-uterine malignancies.
This FDA clearance marks an important milestone for YHLO in our commitment to improve the chemiluminescence immunoassay technologies and bring reliable IVD products all over the world. With the mission of “Focus on healthcare, better life with technology”, YHLO will continue to provide reliable, high-quality healthcare innovations and services worldwide to improve human well-being.
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