Tag Archives: Inova Diagnostics

September 2021—Inova Diagnostics announced FDA 510(k) clearance of its Aptiva system and Aptiva Celiac Disease IgA assay. Aptiva is a fully automated digital multianalyte system for the clinical laboratory. Aptiva received the CE mark in August 2020.

June 29, 2021–Inova Diagnostics announced FDA 510(k) clearance of its Aptiva system and Aptiva Celiac Disease IgA assay.

August 2019—Inova Diagnostics announced FDA 510(k) clearance of its Quanta Flash RF IgM and Quanta Flash RF IgA assays. The chemiluminescent immunoassays are used in human sera and are indicated for the quantitative determination of IgM rheumatoid factor antibodies (Quanta Flash RF IgM) and the semiquantitative determination of IgA rheumatoid factor antibodies (Quanta Flash RF IgA). The presence

February 2019—Inova Diagnostics announced FDA clearance of its Fecal Extraction Device for use in conjunction with Quanta Flash Calprotectin, which aids in the diagnosis of inflammatory bowel disease and helps differentiate IBD from irritable bowel syndrome.

September 2018—Inova Diagnostics announced FDA clearance of its Quanta Flash HMGCR for use on its Bio-Flash random access chemiluminescent system.

September 2018—Inova Diagnostics announced FDA clearance of its Quanta Flash HMGCR for use on its Bio-Flash random access chemiluminescent system.

March 2018—Inova Diagnostics announced the launch of its Quanta-Lyser 3000, a fully automated enzyme-linked immunoassay and immunofluorescence assay processor for use in clinical laboratories.

May 2017—Inova Diagnostics announced that the FDA has granted 510(k) clearance for its Nova Lite DAPI ANCA (ethanol) and Nova Lite DAPI ANCA (formalin) kits for use with Nova View, a digital IFA microscope. Nova Lite DAPI ANCA kits detect anti-neutrophil cytoplasmic antibodies on an automated digital IFA microscope.

December 2015—Inova Diagnostics announced the FDA clearance of Quanta Flash CCP3, an assay that aids in the diagnosis of rheumatoid arthritis. The fully automated chemiluminescent assay, which has demonstrated excellent clinical performance in large cohorts of RA and disease control patients, uses a third-generation cyclic citrullinated peptide technology from Inova Diagnostics.

August 2014—Inova Diagnostics announced the global launch of Quanta Lite Calprotectin, an FDA-cleared, quantitative ELISA that detects calprotectin levels, aids in the diagnosis of inflammatory bowel disease, and can also help differentiate, in conjunction with other laboratory and clinical findings, IBD from irritable bowel syndrome.

Leiden University Medical Center and Inova Diagnostics have completed a worldwide license agreement for technology developed at LUMC to detect antibodies to carbamylated proteins (anti-CarP). This technology represents an important advance in diagnosing rheumatoid arthritis (RA).

Inova Diagnostics’ Bio-Flash rapid-response chemiluminescent analyzer is for use by clinical reference and hospital laboratories. Bio-Flash and the company’s Quanta Flash reagents are for autoimmune disease diagnostic testing.