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Abbott, BioMérieux, Qiagen, Thermo Fisher Get 510(k) Clearances in May

NEW YORK – The US Food and Drug administration in May granted 510(k) marketing clearance to several infectious disease panels, a traumatic brain injury test, and digital pathology software to aid primary diagnosis, among other products.

Abbott got the nod for its Alinity M HSV 1&2/VZV assay for the qualitative detection and differentiation of HSV-1, HSV-2, and varicella-zoster virus (VZV). The real-time PCR assay is used with clinician-collected cutaneous or mucocutaneous lesion swab specimens from symptomatic patients with suspected active infection, and runs on Abbott's Alinity M analyzers.

BioMérieux received the go-ahead for a test to aid with the identification of mild traumatic brain injury. The firm's Vidas TBI (GFAP, UCH-L1) is a pair of automated assays that are used for the quantitative determination of glial fibrillary acidic protein and ubiquitin C-terminal hydrolase-L1 in blood serum from adult patients between one and 12 hours following an injury. The test is designed for use on BioMérieux's Vidas 3 and Vidas Kube analyzers.

Qiagen nabbed 510(k) clearance for a syndromic respiratory panel for viral and bacterial pathogens and a syndromic gastrointestinal panel for viral and bacterial pathogens and parasites, both for use with the firm's QiaStat-Dx system. The QiaStat-Dx Respiratory Panel Plus is a cartridge-based multiplex qPCR assay for the simultaneous qualitative detection and identification of 21 viral and bacterial targets in nasopharyngeal swab samples from individuals with clinical signs and symptoms of respiratory tract infection, with results in about one hour. The newly approved panel is similar to the QiaStat-Dx Respiratory Panel that was cleared by the FDA in 2019 with the addition of SARS-CoV-2 reagents and a reduced concentration of a lysis reagent.

The QiaStat-Dx Gastrointestinal Panel 2 is a cartridge-based multiplex real-time PCR assay for the qualitative detection of 16 common types of gastrointestinal pathogens in stool samples from patients with signs and symptoms of gastrointestinal infection. Results are obtained in about an hour and used along with clinical evaluation, other laboratory findings, and epidemiological data.

Albuquerque, New Mexico-based Indica Labs and Taipei, Taiwan-based AetherAI both received agency clearance in May for software to help pathologists review, interpret, and manage scanned images of surgical pathology slides for primary diagnosis. Indica Labs' Halo AP Dx is an internet browser-based digital pathology platform that is designed for use with the Hamamatsu NanoZoomer S360MD Slide scanner. AetherAI's AetherSlide is web-based software that's designed for use with the Philips Ultra Fast Scanner.

Waltham, Massachusetts-based Thermo Fisher Scientific got the green light for a growth-based quantitative test for the susceptibility of Haemophilus influenzae and Streptococcus pneumoniae to the antibiotic imipenem. The firm's Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the Dilution Range of 0.015-4 µg/ml is designed for use with the firm's Sensititre Vizion instrument for plate reading.

Beckman Coulter secured clearance for updates to two immunoassays that are used to aid the management and monitoring of breast and ovarian cancer patients. The Brea, California-based firm received clearance to modify the substrate and analytical measuring interval of its Access BR Monitor assay for the quantitative determination of CA 15-3 antigen levels in serum and plasma from breast cancer patients. The company also received clearance to update the substrate, sample volume, and analytical measuring interval of the previously cleared Access OV Monitor assay for the quantitative determination of CA 125 antigen levels in serum and plasma of ovarian cancer patients. Both assays are designed for use on the firm's DxI 9000 Access Immunoassay Analyzer instrument.

The US Centers for Disease Control and Prevention received 510(k) clearance for modifications to a multiplex molecular panel that is used for influenza A subtyping. The CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4) was updated with modifications to the virus primer and probe sequences to address evolutionary changes in circulating influenza strains.

Australian firm Genetic Signatures got the agency's go-ahead in May for a syndromic enteric protozoa detection test to identify infection with eight of the most common GI parasites. The firm's PCR-based EasyScreen Gastrointestinal Parasite Detection Kit is used to aid in the identification of infections with Giardia duodenalis, Cryptosporidium, Entamoeba histolytica, Cyclospora cayetanensis, Blastocystis hominis, Dientamoeba fragilis, Enterocytozoon bieneusi, and Encephalitozoon intestinalis.

Kenota Health secured clearance for a point-of-care allergy testing system. The Canadian firm's Kenota 1 System and Kenota 1 Total IgE assay are used together to provide semi-quantitative IgE testing using fingerstick blood samples to aid in the diagnosis of IgE-mediated allergic disorders. The firm said that the system provides results within 30 minutes.

Lastly, California-based iHealth Labs got the agency's go-ahead for an over-the-counter lateral flow assay for COVID-19. The firm's iHealth COVID-19 Antigen Rapid Test is used for the detection of SARS-CoV-2 virus nucleocapsid protein antigen in anterior nasal swab samples from individuals with signs and symptoms of COVID-19. It is authorized for use within the first six days of symptom onset when individuals with negative results are tested a second time within three days using an antigen or molecular test with at least 48 hours between tests.

For 360Dx's FDA 510(k) tracker, click here.