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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.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The provided document details various analytical performance studies demonstrating the device's capabilities. While explicit "acceptance criteria" are not presented in a single, clear list with pass/fail thresholds, the studies' objectives and reported results implicitly define what was considered acceptable performance for the device's de novo classification. The performance data is summarized below based on these implicit criteria.

Table of Implicit Acceptance Criteria and Reported Device Performance

• SKBR3: ~69% (CI: 65%-73%)
• MCF7: ~76% (CI: 73%-79%)
• Hs578T: ~76% (CI: 74%-79%) |
  | Comparison of live vs. fixed cell recovery | Fixed SKBR3 recovery: 88% (more efficient than live). Live SKBR3 recovery: 69%. |
  | Detection Limit | |
  | Minimum number of spiked tumor cells to recover at least one cell >95% of the time | - SKBR3: 3 cells
• Hs 578T: 4 cells
• MCF7: 5 cells |
  | Limit of Blank | 0 cells (no tumor cells detected in unspiked healthy donor blood). |
  | Blood Volume Impact | |
  | No significant impact on efficiency across 5mL, 7.5mL, 10mL volumes (direct harvest) | Mean % SKBR3 Harvest:
• 7.5mL: 71.1%
• 5mL: 62.3%
• 10mL: 66.3%
  (Avg Difference from 7.5mL: -8.8% for 5mL, -4.8% for 10mL; CIs indicate no significant differences across volumes) |
  | Impact of Cytospin™ slide deposition on recovery | Significant cell loss observed. Mean % SKBR3 Deposited:
• 7.5mL: 23.5%
• 5mL: 24.2%
• 10mL: 29.1% |
  | Blood Stability | |
  | No significant impact on recovery for samples stored at RT or 4°C for up to 72 hours | Mean % Harvest (control 71.2%):
• 24h RT: 81.6%
• 48h RT: 74.9%
• 72h RT: 71.1%
• 24h 4°C: 72.9%
• 48h 4°C: 72.5%
• 72h 4°C: 74.1%
  (CIs indicate no significant impact) |
  | Impact on processing time / residual nucleated cells | Storage at RT >4h or 4°C >48h increases residual nucleated cells. RT >24h may increase processing time. |
  | Cell Carryover | |
  | Absence of any cell carryover between samples | 0 of 220 PBS harvests showed fluorescently labeled cells. |
  | Cleaning Reagent Carryover | |
  | Residual cleaning detergent not interfering with cell recovery/morphology/molecular evaluation | No more than 0.01% residual cleaning detergent, which was demonstrated not to impact recovery, morphology, or RNA evaluation. |
  | Cassette Lot Performance | |
  | Consistent performance across multiple cassette lots | - Overall mean % harvest: 81.4% (SD 14.4%, %CV 17.7%) Range: 52.6% to 100%.
• Overall mean % capture: 84.0% (SD 13.2%, %CV 15.6%) Range: 57.6% to 100%. |
  | Interfering Substances | |
  | No significant interference from tested cancer drugs | No significant differences in captured/harvested SKBR3 cells. (Paclitaxel at 80ug/mL, however, showed potential for sample loss/quality reduction). |
  | No significant interference from high albumin or triglycerides | No impact on harvested cells or processing time. |
  | No significant interference from different hematocrit levels on cell capture/harvest | No interference for capture/harvest; high hematocrit increased processing time/residual WBCs, low hematocrit significantly increased residual WBCs. |
  | High WBC count not interfering with SKBR3 cell capture/harvest | No interference with capture/harvest (up to 16x10^9 cells/L). Elevated WBCs lead to increased residual nucleated cells (addressed by downstream assay compatibility). |
  | Compatibility of WBC background with downstream qPCR assay | No negative impact on qPCR performance for most genes (except ERBB2). |
  | Compatibility of WBC background with downstream cytology, FISH, and IF evaluation | No significant impact on quality of WBCs or SKBR3 cells observed in these evaluations. |
  | Reproducibility and Repeatability (Precision) | |
  | Acceptable %CVs for various precision studies (fixed/live cells, PBS/blood, single/multi-site) | - 10-day single site (fixed SKBR3, PBS): Overall avg harvest 81.3%, repeatability %CV 14.4%, within-laboratory %CV 14.5%.
• 20-day 3-site (fixed SKBR3, PBS): Overall avg harvest 75.3%, repeatability %CV 17.0%, reproducibility %CV 20.6%.
• 20-day single site (fixed SKBR3, blood): Overall avg harvest 89.4%, repeatability %CV 10.2%, within-laboratory %CV 10.3%.
• 20-day single site (live SKBR3, blood): Overall avg harvest 70.4%, repeatability %CV 21.1%, within-laboratory %CV 22.0%.
• Combined 20-day precision (fixed/live SKBR3, blood): Repeatability %CV 15.4%, reproducibility %CV 23.2%.
• 5-day single site (live SKBR3, MCF7, Hs578T, blood, various spike levels): Within-run repeatability %CVs ranged from 12.3% to 32.4%, within-laboratory %CVs ranged from 13.3% to 34.1%. Overall (5-50 cells): Repeatability and reproducibility %CV 26.3%. |
  | Clinical Performance (Enrichment of CTCs) | |
  | Comparison of CTC detection in MBC patients vs. healthy volunteers (IF staining) | - HV: 6.9% (5/72) had ≥1 CTC (DAPI+, CD45-, EpCAM+/CK+).
• MBC: 45.3% (34/75) had ≥1 CTC. **Significantly larger proportion in MBC patients (Fisher's exact p

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