US Food and Drug Administration 510(k) Clearance Tracker: In Vitro Diagnostic Tests and Instruments

The product is a nucleic acid amplification test to quantify BK virus in human EDTA plasma.

The semi-quantitative test is for evaluating cellular host response via deformability cytometry of leukocyte biophysical properties and for the early detection of sepsis.

The real-time RT-PCR diagnostic panel is for the qualitative detection of influenza A or B in RNA in upper respiratory tract clinical specimens.

Vitek Compact Pro is an automated instrument for low to medium range applications in clinical and industrial labs and is for the automated quantitative and/or qualitative antimicrobial susceptibility testing of isolated colonies in aerobic Gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp., and yeast.

The system is for the rapid identification and quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration of most Gram-positive bacteria from pure culture belonging to Staphylococcus, Enterococcus, other gram positive cocci and gram positive bacilli and of most Gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and Non-Enterobacteriaceae.

The Access Cortisol assay is a chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine. The DxC 500i Clinical Analyzer is an integrated chemistry-immunoassay work cell that combines Beckman Coulter’s DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System.

The automated digital slide creation, viewing, and management system is intended for use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded tissue. It consists of a scanner, scanner software, image management system, viewer software, and display. 

The multiplexed molecular test simultaneously detects and identifies nucleic acids from multiple bacteria directly from preserved stool samples obtained from patients with signs and/or symptoms of gastrointestinal infection. It runs on the QIAstat-Dx Analyzer 1.0 and identifies Campylobacter, Shigella, Shiga-like toxin, Escherichia coli, Salmonella, and Yersinia enterocolitica.

The molecular test qualitatively detects toxin B gene sequences and identifies 027/NAP1/BI strains of toxigenic Clostridioides difficile from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection. It runs on Cepheid's PCR-based GeneXpert platform, including the firm's GeneXpert Infinity System that includes the GeneXpert Infinity-48s and GeneXpert Infinity-80 instruments and the GeneXpert Xpertise software.

The competitive binding, lateral flow immunochromatographic assays qualitatively and simultaneously detect amphetamine, buprenorphine, secobarbital, benzodiazepines, cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, methamphetamine, methylenedioxymethamphetamine, morphine, methadone, oxycodone, phencyclidine, nortriptyline, marijuana, tramadol, propoxyphene, fentanyl and 6monoacetylmorphine in human urine. The rapid test is intended for over-the-counter use. 

The blood collection device attaches to a peripheral IV catheter system to obtain venous blood specimens into a vacuum tube, blood culture bottle, or syringe from adult and pediatric patients, including those who may have small, fragile, and/or non-palpable veins. 

The susceptibility system is intended for clinical susceptibility testing of Candida spp for micafungin in the dilution range of 0.008-16 μg/mL. Micafungin is active against Candida albicans, Candida glabrata, Candida guilliermondi, Candida krusei, Candida parapsilosis, and Candida tropicalis.

The genotyping test detects Factor II and Factor V alleles from sodium citrate or EDTA anticoagulated whole blood to help with the diagnosis of patients with suspected thrombophilia. It runs on the firm's GeneXpert systems. The update removes a statement from the labeling that the test's performance had not been evaluated with samples from pediatric patients, as the test's performance has now been evaluated in a method comparison study.

The Alinity hq integrated hematology analyzer and Alinity hs slide maker stainer are intended for patient screening in clinical laboratories by qualified healthcare professionals. Abbott is updating the instrument's software to correct falsely increased basophil measurements due to misclassification of lymphocytes as basophils in some blood samples. The Alinity hq analyzer provides complete blood count and a six-part white blood cell differential for normal and abnormal cells in capillary and venous whole blood. 

The immunoassays qualitatively determine the presence of up to 17 drugs, such as amphetamine, secobarbital, and fentanyl, in human urine. The Multi-Drug Urine Test Cup is intended for over-the-counter use.

The single-use, fully integrated, automated RT-PCR test is intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B RNA in nasopharyngeal swab and anterior nasal swab specimens from individuals with signs and symptoms of respiratory tract infection. 

The multiplexed real-time RT-PCR test qualitatively detections and differentiates between SARS-CoV-2, influenza A virus, influenza B virus and respiratory syncytial virus in nasopharyngeal swab specimens collected from patients with signs and symptoms of respiratory tract infection. The test runs on Abbott's automated Alinity m platform. 

The FaStep Pregnancy Rapid Test Cassette qualitatively detects human chorionic gonadotropin (HCG) in human urine to help detect pregnancy early, while the Fastep HCG Rapid Test Cassette is a rapid visual immunoassay intended for use by a healthcare professional to detect HCG in human urine.

The nucleic acid amplification test is intended to qualitatively detect RNA from SARS-CoV-2 isolated and purified from nasopharyngeal and anterior nasal swab specimens obtained from patients with symptoms of COVID-19. 

The chemiluminescent microparticle immunoassay qualitatively detects specific IgG antibodies to herpes simplex virus type 2 in human serum and plasma on Abbott's Architect I system. It is intended for use with sexually active adults or expectant mothers to help with the presumptive diagnosis of HSV-2 infection, although the results may not determine the state of active lesions or associated disease manifestations.