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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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Fenom Flo™ FeNO Monitoring System is a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. FeNO is increased in some airway inflammatory processes, such as asthma, and decreases in response to anti-inflammatory treatment. Fenom Flo measures fractional exhaled nitric oxide (FeNO) according to guidelines established by the American Thoracic Society.

Measurement of FeNO by Fenom Flo is a non-invasive quantitative method to measure the decrease in FeNO concentration in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy as an indication of therapeutic effect in patients with elevated FeNO levels. FeNo measurements are to be used as an adjunct to established clinical assessments. Fenom Flo is suitable for adults and children ages seven years and older.

Fenom Flo should be used in a point-of-care healthcare setting under professional supervision. Fenom Flo should not be used in critical care, emergency care, or anesthesiology.

Fenom Flo™ FeNO Monitoring System quantitatively measures fractional exhaled nitric oxide (NO), an important marker for airway inflammation in exhaled human breath.

The system consists of:

• A handheld FeNO monitoring device (hereafter referred to as "Fenom Flo Device" or "Device") that houses a rechargeable lithium-ion battery, a nitric oxide sensor, and integrated pneumatics and electronics for breath analysis. The device supports secure wireless communication through dedicated hardware and firmware.

• A Point-Of-Care Application (hereafter referred to as a "POC App") operating on a Windows platform serves as the primary interface for displaying FeNO scores in parts per billion (ppb). The POC App offers key features, including test initiation, viewing of current and historical results, quality control, adjustable settings, a patient tutorial, and activity and error tracking. The POC App operates on any healthcare provider's (HCP's) device running Windows 10 or 11. It is the HCP's responsibility to ensure that the device on which the POC App is installed meets all necessary performance, security, and compatibility requirements.

• A single-patient use, non-sterile disposable mouthpiece with an antibacterial/antiviral filter to prepare the exhaled breath for the measurement. The manufacturer is Polytechnic Resources, and the FDA clearance reference is K042758.

• The power supply recharges the battery or enables the device to operate.

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The Dexcom Smart Basal insulin dose calculator is software intended for the management of type 2 diabetes in persons aged 18 years and older requiring long-acting insulin. This is not for use for patients on fast-acting insulin. The Dexcom Smart Basal insulin dose calculator calculates a dose of basal (long-acting) insulin using logged doses and glucose measurements from an integrated continuous glucose monitor (iCGM). The Dexcom Smart Basal insulin dose calculator requires a prescription and initial configuration by a healthcare provider.

The Dexcom Smart Basal system is a basal insulin (long-acting insulin) dose calculator intended for use by individuals with type 2 diabetes. It requires a prescription and initial configuration by a healthcare provider (HCP). The Dexcom Smart Basal system is designed to optimize and recommend basal insulin doses for patients who use compatible Dexcom CGM systems. The Dexcom Smart Basal system produces daily basal dose recommendations using the patients' CGM data, insulin dose logs, and HCP-entered patient-specific treatment parameters. The Dexcom Smart Basal system is comprised of applications that initiate and manage the basal titration process for patients with type 2 diabetes who may benefit from long-term insulin treatment.

The Dexcom Smart Basal system consists of a cloud-based long-acting insulin dose calculator, a patient facing module within a compatible CGM system mobile application, and a web-based provider-facing user interface.

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The Tandem Mobi insulin pump with interoperable technology (the pump) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.

The pump is intended for single patient, home use and requires a prescription. The pump is indicated for use in individuals 2 years of age and greater.

Control-IQ+ technology is intended for use with compatible interoperable continuous glucose monitors (iCGM), alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold.

Control-IQ+ technology is not a substitute for your own active diabetes management. Control-IQ+ technology is intended for the management of Type 1 diabetes mellitus in persons 2 years of age and greater and of Type 2 diabetes mellitus in persons 18 years of age and greater. Control-IQ+ technology is intended for single patient use and requires a prescription

The Subject Device, Tandem Mobi insulin pump with interoperable technology ("Mobi pump", "the pump"), is an Alternate Controller Enabled (ACE) Infusion Pump intended for the infusion of insulin into a patient requiring insulin therapy. The Tandem Mobi insulin pump with interoperable technology ("pump") is screenless and includes visual LED, sound, and vibratory indicators to alert the user of the pump status. The Tandem Mobi insulin pump with interoperable technology system also includes: the Tandem Mobi mobile application and a 2mL (200 insulin unit) Tandem Mobi cartridge and a compatible FDA cleared infusion set.

The Tandem Mobi mobile application ("mobile app") displays all information from, and is the primary controller of, the pump. Through the mobile app, users will program all aspects of basal and bolus insulin delivery therapy including managing personal profiles, viewing pump and CGM data, and actively acknowledging all pump and mobile app alerts, alarms, reminders, notifications, and messages. The Tandem Mobi mobile application will also be used to transmit historical pump and mobile app therapy data to the Tandem Cloud. The Tandem Mobi mobile application will be made available via the Android Play® App store for Android-compatible smartphones based on completed device verification and validation. The Tandem Mobi cartridge is a disposable insulin cartridge compatible only with the Tandem Mobi pump.

The Tandem Mobi ACE pump can be used for basal and bolus insulin delivery with or without a CGM or with any compatible interoperable automated dosing algorithm.

The pump may be used in combination with a compatible continuous glucose monitor (CGM) system. Use of CGM is optional.

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The AllTest Urinary Tract Infection Test is for the qualitative detection of Leukocytes (white blood cells) and nitrite in urine as an aid in the screening of a Urinary Tract infection (UTI). It is intended for over-the-counter home use only.

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For In Vitro Diagnostic Use

For the quantitative measurement of cardiac troponin I (cTnI) in human plasma (heparin) using the VITROS 5600 Integrated System.

Cardiac troponin I is used to aid in the diagnosis of myocardial infarction (MI).

The VITROS hs Troponin I assay is performed using the VITROS Immunodiagnostic Products hs Troponin I Reagent Pack and the VITROS Immunodiagnostic Products hs Troponin I Calibrators on the VITROS 5600 Integrated System. An immunometric immunoassay technique is used. Cardiac troponin I present in the sample reacts simultaneously with streptavidin-conjugated antibody (mouse monoclonal anti- cTnI), bound by biotin-BSA on the wells, and a horseradish peroxidase (HRP)-labeled antibody conjugate (mouse monoclonal anti-cTnI). The antigen-antibody complex is captured by the antibody on the wells. Unbound materials are removed by washing. The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the system. The amount of HRP conjugate bound is directly proportional to the concentration of cardiac troponin I present.

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The Glucose2 assay is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) on the ARCHITECT c System.

Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The Glucose2 assay is an automated clinical chemistry assay.

Glucose is phosphorylated by hexokinase in the presence of adenosine triphosphate (ATP) and magnesium ions to produce glucose-6-phosphate (G-6-P) and adenosine diphosphate (ADP). Glucose-6-phosphate dehydrogenase (G-6-PDH) specifically oxidizes G-6-P to 6-phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide phosphate (NADP) to its reduced form (NADPH). One micromole of NADPH is produced for each micromole of glucose consumed. The NADPH produced absorbs light at 340 nm and can be detected spectrophotometrically as an increased absorbance.

Methodology: Hexokinase/G6PDH

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The On Call® Sure GK Blood Glucose & Ketone Monitoring System is comprised of the On Call® Sure GK Blood Glucose & Ketone Meter, the On Call® Sure Blood Glucose Test Strips, and the On Call® Sure Blood Ketone Test Strips.

The On Call® Sure GK Blood Glucose & Ketone Monitoring System is intended to quantitatively measure blood glucose or blood ketone in fresh capillary whole blood from the fingertip. The system is intended for self-testing by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control program. The system is for in vitro diagnostic use. It should only be used by a single patient and should not be shared. It is not intended for diagnosis or screening of diabetes or for neonatal use.

The On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System is comprised of the On Call® Sure Sync GK Blood Glucose & Ketone Meter, the On Call® Sure Blood Glucose Test Strips, and the On Call® Sure Blood Ketone Test Strips.

The On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System is intended to quantitatively measure blood glucose or blood ketone in fresh capillary whole blood from the fingertip. The system is intended for self-testing by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control program. The system is for in vitro diagnostic use. It should only be used by a single patient and should not be shared. It is not intended for diagnosis or screening of diabetes or for neonatal use.

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The Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human venous whole blood and hemolysate specimens using ion-exchange high performance liquid chromatography (HPLC).

This test is to be used as an aid in diagnosis of diabetes and identifying patients who may be at risk for developing diabetes, and for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

The Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human venous whole blood and hemolysate specimens using ion-exchange high performance liquid chromatography (HPLC). The Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 analyzer is to be used in the clinical laboratory setting. The analyzer hemolyzes and dilutes whole blood specimens and subsequently injects the diluted and hemolyzed sample into the injection valve and onto the TSKgel GR01 HbA1c Column. Manually hemolyzed and prediluted samples can be loaded in sample cups directly for analysis on the analyzer. Separation of hemoglobin fractions is achieved by using differences in ionic interactions between the cation exchange group on the column resin surface and the hemoglobin components by a step gradient elution with three elution buffers of different ionic strengths. Changes in light absorbance at 415nm caused by hemoglobin fractions eluting from the column are monitored. The GR01 software has chromatographic peak retention time windows for the six expected hemoglobin fractions, A1a, A1b, HbF, LA1c+, SA1c, and A0. In addition, the software has retention time windows for the presumptive identification of the common hemoglobin variants, D, S, C, and E. An analysis requires 50 seconds per sample to complete. A printout of the results includes the sample ID, date, percentage, and retention time of each hemoglobin fraction, the SA1c percentage along with a chromatogram of the elution pattern of the hemoglobin fractions. The analyzer is equipped with external USB ports. These can be used to store assay results, to update and backup program versions, to attach an external device, for example an external printer or an optional handheld barcode scanner, and for software installation or backup of data. The last 150,000 assay results are automatically saved to the analyzer's internal memory and can be retrieved as list data in .CSV format and chromatograms in .PDF format.

The Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 system consists of the following components.

• GR01 HbA1c Elution Buffer No. 1, No. 2, No. 3
• TSKgel® GR01 HbA1c Column
• Hemoglobin A1c Controls Levels 1 and 2
  • 21 CFR 862.1660, Product Code JJX
• Hemoglobin A1c Calibrator Set
  • 21 CFR 862.1150, Product Code JIT
• Hemolysis and Wash Solution (L) and (LL)
  • 21 CFR 864.8540, Product Code GGK

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