Skip to main content
Premium Trial:

Request an Annual Quote

Roche, Beckman Coulter, Thermo Fisher, Others Receive FDA Clearances in February

NEW YORK (360Dx) – During February the US Food and Drug Administration cleared in vitro diagnostic tests from Roche Diagnostics, Beckman Coulter, Thermo Fisher Scientific, BioMérieux, and others, according to the agency's website.

Roche Diagnostics received clearance for its Ammonia II assay, an enzymatic test for the measurement of ammonia in human plasma, running on Roche's Cobas c systems. The ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.

Beckman Coulter was granted clearance for its MicroScan Dried Gram-Negative MIC/Combo Panels and Dried Gram-Negative Breakpoint Combo panels to determine antimicrobial agent susceptibility to and/or identification of the species level of aerobic and facultatively anaerobic gram-negative bacilli.

Also in the area of antimicrobial susceptibility testing, Thermo Fisher Scientific received clearance for its Sensititre 20- to 24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or breakpoint susceptibility system with Omadacycline in the dilution range of .008 to 32 ug/mL.

PerkinElmer's Euroimmun business got the nod for its Anti-tissue Transglutaminase ELISA (IgA) test kit to detect IgA class antibodies against tissue transglutaminase in human serum and ethylenediaminetetraacetic acid (EDTA) plasma.  The test kit is used as an aid in the diagnosis of gluten-sensitive enteropathy, also known as celiac disease, and dermatitis herpetiformis, also known as Duhring's disease.

The firm also received clearance for use of its Anti-tissue Transglutaminase ELISA (IgG) test kit for the qualitative determination of IgG class antibodies against tissue transglutaminase in human serum and EDTA plasma to diagnose celiac disease.

BioMérieux was granted clearance for two culture bottle products. Both its BacT/Alert FA Plus Culture Bottles and its BacT/Alert PF Plus Culture Bottles are used with BacT/Alert Microbial Detection Systems in qualitative procedures for recovery and detection of bacteria and yeast from blood. Its BacT/Alert FA Plus Culture Bottles are also used for recovery and detection of bacteria and yeast from normally sterile body fluids in addition to blood.

Separately, the firm received clearance for its Vitek 2 Gram-negative Susceptibility Card for use with its Vitek 2 Systems in clinical laboratories as a test to determine the susceptibility of clinically significant aerobic gram-negative bacilli to antimicrobial agents.

The FDA cleared the CoaguSense Prothrombin Time /INR Monitoring System to measure INR units and provide prothrombin time results expressed in seconds, enabling healthcare professionals to monitor patients on warfarin-type anticoagulation therapy at the point of care.

The agency gave EKF Diagnostics the go-ahead for use of its Quo-Test A1c System for detecting glycated hemoglobin levels in venous whole-blood samples in a clinical laboratory. Measuring the percentage of glycated hemoglobin is used to monitor long-term glycemic control in people previously diagnosed with diabetes.

Sekisui Diagnostics was granted clearance for its Sekure Acetaminophen L3K Assay to measure acetaminophen in serum, lithium heparin plasma, and sodium heparin plasma, and for the diagnosis and treatment of acetaminophen overdose toxicity.

The FDA cleared U&U Medical Technology's Blood Collection Sets for use in routine venipuncture procedures. Following blood collection, a safety shield is activated to cover the needle and prevent accidental needle-stick injury.

The FDA also cleared HemoCue's Hb 801 System for the measurement of hemoglobin in capillary or venous whole blood in point-of-care settings; Grifols Procleix assay for the detection of Babesia, a malaria-like parasite that can be transmitted through tick bites and donated blood; and Bio-Rad Laboratories' first liquid biopsy assay and Droplet Digital PCR system for diagnostic use.