[306dx – 11/11/20] ─ October was another slow month for 510(k) clearances from the US Food and Drug Administration amid the ongoing coronavirus pandemic. During the month, the agency granted only a few clearances, according to its website.
Saluggia, Italy-based DiaSorin got the nod for its Liaison Testosterone xt chemiluminescence immunoassay running on the firm’s Liaison XL analyzer to measure testosterone in serum and plasma.
Clinicians measure testosterone to diagnose disorders involving the sex hormones. In males, testosterone measurements are used to diagnose primary and secondary hypogonadism, delayed or precocious puberty, and impotence, and in females to diagnose polycystic ovaries, adrenogenital syndromes, and masculinization due to tumors.
Additionally, Springville, Utah-based Arlington Scientific got the green light for its ASI Automated RPR Test for Syphilis, a qualitative and semiquantitative flocculation assay for the detection of nontreponemal antibodies in serum and plasma and the diagnosis of syphilis infection. The rapid plasma regain (RPR) test runs on the company’s ASI Evolution Automated Analyzer.
The FDA also cleared the CellaVision DC-1 automated cell-locating test, developed by Lund, Sweden-based CellaVision to provide differential counts of white blood cells, characterization of red blood cell morphology, and platelet estimates. The test automatically locates blood cells on peripheral blood smears and presents images of them for review. A skilled operator trained in recognition of blood cells identifies and verifies the suggested classification of each cell according to type.
Holliston, Massachusetts-based Diamond Diagnostics got the go-ahead for its SmartLyte Plus analyzer, which uses ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium, and lithium in serum, sodium, heparin, plasma, and venous whole blood, as well as the measurement of sodium, potassium, and chloride in pre-diluted urine samples.
Its measurements are used to monitor electrolyte balance in the diagnosis of excessive secretion of the hormone aldosterone; chronic excretion of large amounts of dilute urine; adrenal hypertension; Addison’s disease; dehydration; inappropriate antidiuretic hormone secretion; and other diseases involving electrolyte imbalance.
Seattle-based Magnolia Medical Technologies was granted clearance for its Steripath Micro Blood Collection System to draw blood for in vitro diagnostic testing. The system diverts and sequesters a specimen prior to the collection of a subsequent test sample, to reduce the frequency of blood culture contamination.
In other regulatory news, Israeli hematology firm Scopio Labs received clearance for its X100 hematology imaging and analysis system and its Full Field Peripheral Blood Smear application.
Becton Dickinson announced in October that it received 510(k) clearance for its BD FACSLyric Flow Cytometer with integrated BD FACSDuet Sample Preparation System, consisting of a fully automated sample-to-answer solution for flow cytometry.