Roche Elecsys sFlt-1/PlGF ratio for preeclampsia receives FDA 510(k) clearance
Roche announced that the Roche Elecsys sFlt-1/PlGF ratio for preeclampsia has received 510(k) clearance from the United States Food and Drug Administration (FDA).
The ratio is a prognostic test intended to stratify hospitalized pregnant women with hypertensive disorders of pregnancy into low- and high-risk categories for developing severe preeclampsia within two weeks of testing.
The Elecsys sFlt-1 and Elecsys PlGF assays are provided in separate kits. The ratio must be calculated using Elecsys sFlt 1 and Elecsys PlGF results obtained on the same patient sample and the same cobas immunoassay analyzer per the intended use. The assay results should be used only in conjunction with information available from clinical evaluations and other standard-of-care procedures. The test result is not to be used to replace clinical judgment.
