US FDA 510(k) Clearance for MRSA Analysis Module

29th October 2021

Clever Culture Systems is delighted to announce the successful 510(k) clearance of APAS Independence with associated MRSA Analysis Module by the United States FDA.

The APAS Independence automates the screening, sorting and interpretation of culture plates and remains the first of its kind to auto-verify negative culture plates in the United States. The APAS Independence responds to the growing demands of busy laboratories and the fast-growing automated pathology market, processing 200 culture plates an hour.

FDA 510(k) Clearance as a Class II Medical Device

The APAS Independence with MRSA Analysis Module has been cleared as a Class II medical device by the FDA. The APAS Independence is now available for use with both Urine and MRSA Analysis Modules.

The APAS Independence successfully identifies culture plates with significant bacterial growth. The instrument differentiates culture plates needing further review by a microbiologist from those with no significant growth. The plates showing no significant growth plates are automatically reported to the Laboratory Information System (LIS) and removed from the culture plate workflow with no further work up required.

Clever Culture Systems General Manager, Peter Bradley said:

“This second FDA clearance following the initial APAS Independence and associated Urine Analysis Module clearance, demonstrates the power of our cutting-edge technology to auto-validate negative results. This use of AI based active decision making frees up critical resources for our customers and gives time back to the lab for more value-added activities.”

MRSA Healthcare Threat & Testing by US Laboratories

Methicillin-resistant Staphylococcus aureus (MRSA) is one of the leading causes of multi-drug resistant infections and is often the cause of hospital acquired infections. Patients suffering from MRSA infections have a mortality rate that is 64% higher than patients with drug sensitive infections, hence, its management and treatment is a growing priority for healthcare systems.

In the United States, MRSA is the second largest specimen type by volume tested for by clinical microbiology laboratories and together with Urine specimens, accounts for up to 70% of all culture plates processed by laboratories. The availability of the MRSA Analysis Module to customers in the United States delivers efficiencies by automatically reading and reporting the negative plates which typically account for over 95% of total MRSA workflow.

The performance of the MRSA Analysis Module has been proven by laboratories around the world. In 2020, The Johns Hopkins Hospital in Baltimore completed an evaluation of the MRSA Analysis Module within their laboratory. In the study, the performance of the APAS Independence was assessed over a three-month period, reviewing 4,603 patient samples. The APAS Independence successfully identified all positive MRSA specimens, including identifying 3 positive samples previously missed by the microbiologists.

The APAS Independence is distributed in the United States of America by Thermo Fisher Scientific.