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

The testing instrument is used for the quantitative determination of glucose in whole blood, serum, and plasma samples 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 lateral flow assay 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 lateral flow assays are used for the simultaneous qualitative detection in urine of 14 drugs of abuse that have been consumed.

The blood culture sample preparation platform is used to aid the identification of pathogens and treatment of sepsis. It is comprised of the firm's Arc Module, software, and BC kit.

The panel is used for the direct detection of Candida species in blood samples from patients with symptoms of or predispositions to invasive fungal infection. This is an updated clearance to allow the use of the blood test in pediatric patients.

The immunoassay is used for the qualitative detection of total antibodies to Treponema pallidum in serum and plasma to aid the diagnosis of syphilis.

The chemiluminescent microparticle immunoassay is for the qualitative detection of IgM antibodies to Toxoplasma gondii in human serum to aid in diagnosing acute or recent Toxoplasma gondii infection. 

The reagents are for the qualitative determination of total antibodies to Treponema pallidum-specific antigens in human plasma and serum on the Vitros 5600 Integrated System.

The lateral flow immunochromatographic assay is for the rapid, qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen in anterior nasal swab specimens to help in diagnosing SARS-Co-V-2 infections. 

The test is for the qualitative detection of hCG in human urine to aid in the early detection of pregnancy.

The assay is for the qualitative detection of IgG antibodies to Borrelia burgdorferi in human serum to aid in diagnosing Lyme disease. 

The assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroperoxidase antibody levels in human serum and plasma to aid in the diagnosis of thyroid autoimmune disorders.

The viral load monitoring test is for quantitating the amount of HIV ribonucleic acid in human body fluids.

The transport media is for collecting and transporting specimens suspected of containing viruses, including influenza A/B, adenovirus, and echovirus for laboratory testing. 

The assay is for aiding in the identification of patients who have specific HLA alleles or express specific HLA antigens and may benefit from treatment with a corresponding therapy, or who may be at risk for a serious adverse reaction if treated with a corresponding therapy. 

The rapid immunochromatographic assay qualitatively detects respiratory syncytial virus nucleoprotein antigen in anterior nasal swab specimens from patients with signs and symptoms of respiratory infections.

The Atellica CH HDL Cholesterol (HDLC) assay is used for the quantitative determination of HDL cholesterol and the Atellica CH LDL Cholesterol (LDLC) assay is used for the quantitative determination of LDL cholesterol. Both assays are used with serum and plasma samples and are designed for use on the Atellica CI Analyzer.

The direct-draw venous whole-blood collection device is intended for the collection, stabilization, and transport of venous whole-blood samples for use with cell-free DNA next-generation sequencing-based liquid biopsy tests.

The analyzer quantitatively measures glucose and hematocrit percentage in whole blood samples from lithium-heparinized syringes or capillary tubes. 

The immunoassay quantitatively measures cardiac troponin I in human serum or plasma using the Atellica IM analyzer and can be used to help diagnose acute myocardial infarction. The updated clearance allows the test to also be used to aid the prognosis of major adverse cardiac events and death over 30-, 90-, 182-, and 365-day periods in patients with signs and symptoms of acute coronary syndrome.