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The Tru Kidney Health Test Panel is part of the TruWellness Panel™ and is intended for use on the Tru Analyzer. The Tru Kidney Health Test Panel (part of the TruWellness Panel™) is an in vitro diagnostic device and intended to be used for the quantitative determination of Creatinine (CRE) and Blood Urea Nitrogen (BUN) in lithium-heparinized venous whole blood in clinical laboratory or point-of-care settings. From the CRE determination, Estimated Glomerular Filtration Rate (eGFR) is calculated by the analyzer.

The Tru Kidney Health Test Panel (part of the TruWellness Panel™) is an in vitro diagnostic test system that aids the physician in diagnosing the following disorders in adults 18 years of age or older:

• Creatinine (CRE): Renal disease and monitoring of renal dialysis.
• Blood Urea Nitrogen (BUN): Certain renal and metabolic diseases.

The Tru Analyzer is an automated, multi-assay integrated system, containing an absorbance reader, a bead scanner, and a cell imager for in vitro diagnostic use. This analyzer is intended for the quantitative determination of various analyte concentrations found in lithium-heparinized venous whole blood. It is for clinical laboratory or point-of-care use.

Use only TruWellness Panel™ test kits with the Tru Analyzer.

The TruSystem is an automated, integrated in vitro diagnostic platform consisting of the Tru Analyzer and the Tru Kidney Health Test Panel (part of the TruWellness Panel™), a Single-Use Consumable Kit that includes a Disc and a Support Pack. Designed for point-of-care and clinical laboratory use, the system enables the simultaneous measurement of clinical chemistry, immunoassay, and hematology parameters from a lithium-heparinized venous whole blood sample in a single run. The TruSystem delivers quantitative results for routine clinical chemistry and immunoassay analytes as well as a complete blood count (CBC) with a 3-part differential, all without the need for specialized operating skills, external calibration, or complex infrastructure.

The Tru Analyzer is a benchtop instrument that fully automates sample processing, assay execution, and result reporting. Its touchscreen interface allows operators to control workflows, initiate tests, and review results with minimal training. The Single-Use Consumable Kit and blood sample are loaded into the analyzer drawer, where all necessary processing takes place. Internally, the Tru Analyzer integrates:

• A high precision pipettor for automated sample and reagent handling,
• An onboard centrifuge to separate whole blood into plasma,
• A closed-loop thermal control system to maintain precise assay temperatures,
• A motion control system to fully automate sample processing,
• Dedicated detection modules for clinical chemistry, immunoassay, and hematology testing,
• A high-definition camera used to collect assay readings, image capture, and instrument quality control checks,
• An electronics board to manage individual module boards and associated firmware,
• An integrated computer running the instrument software, accessible via the touchscreen user interface.

The Tru Analyzer is factory-calibrated and continuously monitors its performance using optical sensing and electronic feedback mechanisms. Every time the analyzer is powered on or a Single-Use Consumable Kit (TruWellness Panel™) is loaded, the system runs an automated self-test to verify that it remains within calibration and is functioning properly. Internal quality control (QC) checks occur throughout the testing process to ensure the integrity of the analyzer, Disc, and Support Pack.

If an internal QC check does not meet specifications, the instrument will automatically suppress result reporting to prevent the release of potentially inaccurate results. Any impacted tests will display associated codes in the footnotes of the patient report. The Tru Analyzer also applies result flags to highlight conditions that may indicate abnormalities in the patient sample or require attention. These flags appear in-line with impacted assay results for clear visibility. If a system operation failure occurs, the Tru Analyzer will halt the run, and no results will be generated. In these cases, the instrument displays an on-screen error message with a unique code and step-by-step instructions to guide resolution. These measures ensure the system provides accurate results, while requiring no special user knowledge, training, or on-site calibration.

The Single-Use Consumable Kit (TruWellness Panel™) houses all the components needed to process and analyze samples on the Tru Analyzer, including dried reagents, internal process control solutions, barcodes that manage the identity of the kit lot (e.g., Disc and Support Pack ID), calibration information, dilution buffers, and single-use plastic pipette tips. It also serves as a waste container which the user discards at the end of the run.

The Tru Kidney Health Test Panel is part of the TruWellness Panel™ and is intended for use on the Tru Analyzer. The Tru Kidney Health Test Panel (part of the TruWellness Panel™) provides in vitro quantitative determination of Creatinine (CRE), Blood Urea Nitrogen (BUN), and calculated estimated Glomerular Filtration Rate (eGFR) in lithium-heparinized venous whole blood samples.

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The PennPET Explorer PET system is a diagnostic imaging device that, together with the co-located IQon CT scanner, combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The IQon CT system images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET system images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. Together, these systems are used for the purposes of detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of various diseases in oncology, cardiology, and neurology.

The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. The CT scanner can also be operated as fully functional, independent diagnostic tool, including for use in radiation therapy planning.

The PennPET Explorer is based on the PET technology of its predicate device, the Philips Vereos PET/CT scanner, but follows the model of its reference device, the previous Philips Gemini TF PET/CT by having co-located—yet separated—PET and CT scanners served by a common patient table. The PennPET Explorer uses a newly designed 142 cm axial field-of-view (AFOV) PET gantry and is intended to be used with a co-located Philips IQon multi-energy CT and patient table.

The PennPET Explorer PET gantry is a modular system comprising six PET detector rings stacked axially, yielding a 142 cm axial FOV. This allows imaging of the human head, torso, and upper legs in a single frame without moving the patient. The entire imaging chain of components from the detectors to the data acquisition computers is supplied by Philips and consists of components that are used in the Vereos PET scanner. The mechanical structure and data processing software have been modified and developed to handle the additional data from all six PET rings simultaneously.

Each of the six detector rings is substantially equivalent to a Philips Vereos PET scanner.

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