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FDA Clears Assays From CDC, Agilent, Abbott

NEW YORK (360Dx) – Diagnostic tests from the Centers for Disease Control and Prevention, Agilent Technologies, and Abbott Laboratories received 510(k) clearance from the US Food and Drug Administration last month.

The CDC was granted clearance for its Human Influenza Virus Real-Time RT-PCR Diagnostic Panel; Influenza A/B Typing Kit; Influenza A Subtyping Kit (ver 2); Influenza B Lineage Genotyping Kit; and Influenza A/H5 Subtyping Kit (ver 3).

CDC's panels and kits were cleared for use with the Applied Biosystems 7500 Fast Dx Real-time PCR system. The Human Influenza Virus Real-Time RT-PCR Diagnostic Panel is configured in four separate kits, according to an FDA document. Meantime, the Influenza A/B Typing Kit contains reagents and controls of the Human Influenza Virus Real-Time RT-PCR Diagnostic Panel and is intended for use on the ABI 7500 instrument in conjunction with clinical and epidemiological information.

The kit is for qualitatively detecting influenza virus type A or B viral RNA in upper respiratory tract specimens, nasal swabs, throat swabs, nasal aspirates, nasal washes, and other collection methods.

The Influenza A Subtyping Kit (ver 2) is for determining the subtype of seasonal human influenza A viruses as seasonal A (H3) and/or A(H1) pdm09 from viral RNA in upper respiratory tract clinical specimens.

The Influenza B Lineage Genotyping Kit is for determining the genetic lineage of human influenza B viruses as B/Victoria or B/Yamagata lineage from viral RNA from upper respiratory tract clinical specimens.

The Influenza A/H5 Subtyping Kit is for presumptively identifying virus in patients who may be infected with influenza A subtype A(H5) (Asian lineage) from viral RNA in human respiratory specimens.

The FDA also cleared Agilent's GenetiSure Dx Postnatal Assay for the qualitative postnatal detection of copy number variations and copy-neutral loss of heterozygosity in genomic DNA from peripheral whole-blood in patients referred for chromosomal testing based on clinical presentation. The assay is for detecting CNVs and copy-neutral loss of heterozygosity associated with developmental delay, intellectual disability, congenital anomalies, or dysmorphic features, an FDA document said.

Abbott's i-STAT Hematocrit test was cleared for use on the firm's i-STAT Alinity platform. The test is for the in vitro quantification of packed red blood cell volume fraction in arterial or venous heparinized whole blood, or in arterial or venous non-anticoagulated whole blood. Hematocrit measurements can be used to determine and monitor normal or abnormal total red blood cell volume status, which can be associated with conditions such as anemia and erythrocytosis.

Other firms whose tests received 510(k) clearance in August include Immco Diagnostics for its ImmuLisa Enhanced Anti-Mitochondria IgG Antibody ELISA to aid in diagnosing primary biliary cirrhosis in conjunction with other laboratory tests and clinical findings.

Also, Viramed Biotech's Borrelia B31 ViraChip IgM Test Kit was cleared. The in vitro qualitative protein microarray assay is for detecting IgM antibodies to Borrelia burgdorferi in human serum. B. burgdorferi is the causative agent for Lyme disease.