NEW YORK – The US Food and Drug Administration in September granted 510(k) marketing clearances for tests to aid the diagnosis of syphilis and Candida infections, a blood culture preparation system that is used to aid the identification and treatment of sepsis, and a biochemistry analyzer.
Beckman Coulter got the green light for an immunoassay to aid the diagnosis of syphilis. The Brea, California-based firm's Access Syphilis assay is for qualitatively detecting total antibodies to Treponema pallidum in serum and plasma. The test is for use on the firm's Access Immunoassay instruments and can be used in conjunction with a non-treponemal lab test and clinical findings to aid the diagnosis of syphilis.
Lexington, Massachusetts-based T2 Biosystems received an updated FDA clearance to allow the use of its blood test for Candida in pediatric patients. The T2Candida panel is for the qualitatively direct detection of Candida species in blood samples from patients with symptoms of or predispositions to invasive fungal infection. The test is for use on the firm's T2Dx Instrument and leverages DNA amplification along with magnetic resonance technology for the detection of five Candida species in three to five hours. Blood culture is necessary for susceptibility testing or further identification.
Tucson, Arizona-based Accelerate Diagnostics secured marketing clearance for a blood culture sample preparation platform that is used to aid the identification of pathogens and treatment of sepsis. The firm's Accelerate Arc System, comprising its Arc Module, software, and BC kit, is used to prepare concentrated microbial suspensions from positive blood culture samples for identifying bacteria or yeasts. It is designed for use with Bruker's MALDI Biotyper CA (MBT-CA) System and MBT-CA Sepsityper software.
Yellow Springs, Ohio-based firm YSI got the nod for a testing instrument to aid the diagnosis and treatment of carbohydrate metabolism disorders such as diabetes mellitus and idiopathic hypoglycemia as well as the diagnosis and treatment of pancreatic islet cell tumors. The firm's semi-automated YSI 2900C Biochemistry Analyzer is for the quantitative determination of glucose in whole blood, serum, and plasma samples.
China-based Guangzhou Wondfo Biotech gained 510(k) clearance for an over-the-counter lateral flow assay for COVID-19. The Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) is for the qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in anterior swab samples from individuals with signs and symptoms of COVID-19. The test is for use with self-collected samples from individuals aged 14 years and older or adult-collected samples from individuals aged 2 years and older when retesting is performed between 48 and 72 hours following an initial negative test.
Lastly, Hangzhou Alltest Biotech got the go-ahead for two multidrug lateral flow assays for the identification of drugs of abuse that have been consumed. The China-based firm's AllTest Multi-Drug Urine Test Panel and AllTest Multi-Drug Rapid Urine Test Panel are used for the simultaneous qualitative detection in urine of 14 drugs.
For 360Dx's FDA 510(k) tracker, click here.