Q-linea Receives CE-IVD Mark for Its ASTar Bacterial Diagnostic
Q-linea has received CE-IVD mark certification under the EU’s In Vitro Diagnostics Regulation for its ASTar antimicrobial susceptibility testing system.
ASTar Instrument and ASTar BC G-Kit perform a single, integrated analysis of the combination of the number of antibiotics and the number of double dilution steps of each antibiotic in patients being treated for gram-negative bacterial infections.
The system can analyze difficult-to-grow or “fastidious” gram-negative bacteria, the company said.
The antimicrobial susceptibility testing device received a Breakthrough Device designation from the FDA earlier this year but has not yet received the agency’s 510(k) clearance.