NEW YORK – The US Food and Drug Administration granted in April 510(k) marketing clearances for assays for acute and chronic diseases, two COVID-19 lateral flow assays, an automated sepsis testing system, and a urinalysis instrument, among others.
Beckman Coulter got a green light during April for three chemiluminescent immunoassays that are designed for use on the firm's Access immunoassay analyzers. The Access EPO assay is used for the quantitative determination of erythropoietin concentrations in serum or plasma to aid in the diagnosis of anemias and polycythemias. The firm's Access Ostase assay is used for the quantitative measurement in serum and plasma of bone alkaline phosphatase as an indicator of osteoblastic activity to aid in the management of postmenopausal osteoporosis and Paget's disease. Finally, the Access NT-proBNP assay is used for the quantitative determination of N-terminal pro B-type natriuretic peptide concentrations in serum or plasma to aid in the diagnosis of acute heart failure in an emergency department, assess heart failure severity, and stratify patients by risk.
Siemens Healthineers received a nod for an assay that is used to measure thyroid stimulating hormone produced by the anterior pituitary and aid in the diagnosis of thyroid or pituitary disorders. The Advia Centaur TSH3-Ultra II assay is used for the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in serum and plasma, and it is designed for use on the Advia Centaur XP instrument.
Sectra got FDA clearance for its digital pathology software that is used for image sorting, analysis, and reporting in combination with Danaher subsidiary Leica Biosystems' imaging scanners. The Sectra Digital Pathology Module is designed for use in the viewing and management of scanned surgical pathology slides that are prepared from formalin-fixed paraffin-embedded tissue to aid in the review and interpretation of digital images for primary diagnosis. It is designed for use with Leica's Aperio GT 450 Dx scanner.
Swedish firm Q-linea was given the go-ahead for an automated sepsis testing system and a kit for the analysis of Gram-negative bacteria from positive blood cultures. The firm's ASTar System is used to provide quantitative phenotypic antimicrobial susceptibility and minimum inhibitory concentration results from positive blood cultures within 24 hours using a disc-based format, and it can analyze up to 12 samples simultaneously with random access and a load-and-go operation that requires two minutes of hands-on time. The ASTar BC G- Kit is used with the system for the analysis of Gram-negative bacteria.
Acon Laboratories got a green light for a home-use lateral flow immunoassay for COVID-19. The Flowflex Plus COVID-19 Home Test is used for the qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in anterior nasal swab samples and is designed for self-testing by adults and children ages 14 years and older.
Also, Healgen Scientific nabbed clearance for a prescription-use lateral flow immunoassay for COVID-19. The Healgen Rapid COVID-19 Antigen Test is used for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal swab samples from individuals with signs and symptoms of upper respiratory infection within the first six days of symptom onset.
URIT Medical Electronic got 510(k) clearance for an automated urinalysis instrument that is used to provide information on patient carbohydrate metabolism, kidney and liver function, acid-base balance, and bacteriuria. The UC-1800 Automatic Urine Analyzer is used to provide semi-quantitative measurements in a urine sample of ascorbic acid, microalbumin, leukocytes, creatinine, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood, and urine pH as well as the qualitative determination of nitrite.
Shenzhen New Industries Biomedical Engineering received clearance for its fully automated immunoassay analyzer, the Maglumi X3, which uses chemiluminescence for the qualitative or quantitative analysis of analytes in clinical samples. The China-based firm also got a green light for its Maglumi 25-OH Vitamin D assay that is designed for use on the Maglumi X3 instrument for the quantitative determination of 25-OH Vitamin D to aid in the assessment of vitamin D sufficiency.
Meanwhile, Affinity Biosensors got a nod for its multiplex LifeScale AST system that uses a microfluidic sensor and resonant frequency to calculate organism concentrations and mass distribution for quantitative antimicrobial susceptibility testing in positive blood cultures. The system provides interpretive results for specific drug and organism combinations that are intended for use with other clinical and laboratory findings.
The firm received clearance for its LifeScale Gram Negative Kit that is used with the LifeScale AST system to test for antimicrobial susceptibility in positive blood culture samples that have been confirmed with Gram stain to contain Gram-negative bacilli.
For 360Dx's FDA 510(k) tracker, click here.