NEW YORK – Clever Culture Systems said this week that it has completed CE marking for its APAS Independence automated culture plate reader, which has an associated MRSA analysis module.
The APAS Independence is an automated culture plate reader that reduces the manual reading of nonsignificant plates. The instrument can read 200 plates per hour and automatically remove nonsignificant plates from the workflow using artificial intelligence and imaging analysis technology.
The instrument's CE mark registration coincides with a clinical study for an associated MRSA analysis module. In the study, the APAS Independence with the analysis module met target sensitivity and specificity requirements. The system will be available for sale after documentation for the CE mark is completed.
According to the Bäch, Switzerland-based Clever Culture Systems, the higher testing rate for MRSA in Europe, as well as the high negativity rate for MRSA tests, makes it well-suited for the APAS Independence, since the instrument automatically removes negative plates.
The MRSA analysis module will be available in Australia and the US in 2020, after clearance from the US Food and Drug Administration. The APAS Independence received 510(k) clearance from the FDA earlier this year for use with its associated urine analysis module.
Clever Culture Systems is a joint venture of Adelaide, Australia-based LBT Innovations and Tuttlingen, Germany-based Hettich Holding Beteiligungs- und Verwaltungs-GmbH.