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Abbott, Alere, Roche, and Others Receive FDA Clearances in May

NEW YORK (360Dx) – Abbott, its subsidiary Alere, and Roche were among companies that received US Food and Drug Administration clearances in May for their in vitro diagnostic tests, according to the FDA website.

Roche Ventana Medical Systems received clearance for the Ventana CD30 (Ber-H2) assay, which is intended for the qualitative detection of the CD30 protein in tissue stained with a Ventana BenchMark Ultra instrument and its OptiView DAB IHC Detection Kit. CD30-positive staining results can aid in identifying classical Hodgkin lymphoma, anaplastic large cell lymphoma, and cutaneous T-cell lymphoma. The assay should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls, the FDA said.

The FDA also approved an additional claim for Roche's Cobas Zika test for use on the Cobas 6800 and 8800 systems to enable streamlined screening of multiple individual blood or plasma donations that have been pooled together.

Alere received clearance for the Afinion HbA1c Dx, which is used for measurement of glycated hemoglobin, or the percentage of hemoglobin A1c, in human venous and capillary whole blood. The test is intended as an aid in the diagnosis of diabetes and in identifying patients who may be at risk for developing diabetes. The measurement of HbA1c percentage is recommended as a marker of long-term metabolic control in persons with diabetes mellitus.

The FDA also cleared the Alere i Strep A 2, a rapid molecular test that uses isothermal nucleic acid amplification for the qualitative detection of Streptococcus pyogenes, or Group A Streptococcus bacterial nucleic acid, in throat swab specimens obtained from patients with symptoms of pharyngitis. The test is intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections.

Alere's parent company Abbott Laboratories received clearance for a clinical chemistry magnesium assay used for the quantitation of magnesium in human serum or plasma on Abbott's Architect c8000 system. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia, which are abnormally low plasma levels of magnesium, and hypermagnesemia, which are abnormally high plasma levels of magnesium.

Gold Standard Diagnostics received clearance for a Borrelia burgdorferi IgG/IgM ELISA Test Kit intended as a first-step test for the detection in human serum of IgG and IgM antibodies to B. burgdorferi from symptomatic patients or people suspected of infection. Positive and equivocal results must be supplemented by testing with a second-step Western blot assay, the FDA said.

The agency granted clearance to Sekisui Medical for a chromogenic test that includes the CP3000 Coagulation Analyzer, Coagpia AT Reagent, Coagpia Calibrator, and Coagpia Control Set. The analyzer, an automated blood coagulation instrument, performs tests for specific parameters in citrated human plasma. It can run chromogenic assays that allow analysis for both direct hemostasis measurements and calculated parameters, and uses two photometric detection methods — light scattering and absorbance.

The FDA cleared T2 Biosystems' T2Bacteria Panel that detects species of bacteria in whole-blood samples from patients with potential bloodstream infections. The panel runs on the firm's T2Dx instrument. In around five hours, it identifies five of the most common and deadly sepsis-causing species of bacteria — Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Staphylococcus aureus.

Early in May, Immucor said that the FDA cleared its Echo Lumena fifth-generation immunohematology instrument for donor-patient blood matching.

BacterioScan received 510(k) clearance for its 216Dx urinary tract infection detection system, which uses a laser sensor to detect UTIs in three hours versus two days with traditional methods.