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The Parsortix® PC1 system is an in vitro diagnostic device intended to enrich circulating tumor cells (CTCs) from peripheral blood collected in K>EDTA tubes from patients diagnosed with metastatic breast cancer. The system employs a microfluidic chamber (a Parsortix cell separation cassette) to capture cells of a certain size and deformability from the population of cells present in blood. The cells retained in the cassette are harvested by the Parsortix PC1 system for use in subsequent downstream assays. The end user is responsible for the validation of any downstream assay. The standalone device, as indicated, does not identify, enumerate or characterize CTCs and cannot be used to make any diagnostic/prognostic claims for CTCs, including monitoring indications or as an aid in any disease management and/or treatment decisions.

The Parsortix® PC1 system is a bench top laboratory instrument consisting of five main subsystem components: - . Parsortix PC1 instrument incorporating a computer, keypad and display, pneumatic and hydraulic components including reservoir bottles and tubes, a separation cassette mounting clamp and other electronics to control the instrument hardware and behavior. - Parsortix PC1 Software consisting of a Windows 7 Embedded operating system together . with dedicated Parsortix PC1 proprietary Windows application software (Software). - A set of embedded and encrypted Protocol Files (Protocols) that are sequences of simple . instructions, interpreted by the Software and used to control the instrument fluidic and hydraulic components and circuits. The Protocols supplied embedded within the Software enable the four core instrument processes: Clean, Prime, Separate, and Harvest. - Parsortix PC1 MBC-01 Metastatic Breast Cancer Kit which contains Separation Cassettes . (n = 10, 50 or 100), Cleaning Cassettes [(n = 1, 5, or 10), one Cleaning Cassette for every multiple of 10 x separation cassette], Encrypted Instrument protocol file distributed on a USB memory stick as required to perform the proposed intended use, Cassette labels and one package insert (per kit) containing instructions for use and expected performance data for the Parsortix PC1 instrument, when used in conjunction with the MBC-001 Metastatic Breast Cancer Kit. - Parsortix PC1 ICT-01 Instrument Control Test Kit which contains Control tubes . containing a known, aliquoted cell suspension which is used to periodically confirm acceptable performance of the system, Separation Cassettes Polystyrene 12mL 16x100 mm tubes (n = 10 or 25) and one package insert (per kit) containing instructions for use for the ICT-001 Instrument Control Test Kit.