Search Results

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

The Nova Max Creat eGFR Monitoring System is comprised of the Nova Max Creat eGFR Monitor and the Nova Max Creat eGFR Test Strips.

The Nova Max Creat eGFR Monitoring System is intended for in vitro diagnostic use for the quantitative measurement of creatinine and estimation of glomerular filtration rate (eGFR) in fresh capillary whole blood obtained from the fingertip of adult patients aged 18 and above. The system is intended for single patient home use by prescription only and should not be shared. It is intended for use by patients as an aid to monitor kidney function on the order of a treating healthcare professional.

The Nova Max Creat eGFR Monitoring System consists of Nova Max Create eGFR Monitor and Nova Max Create eGFR Creatinine-Test Strips. The Nova Max Creat eGFR test strips, Nova Max Creat eGFR control solution (Level 1 and Level 2), and a single-use, disposable, 21 gauge safety lancet can be purchased separately.

Nova Max Creat eGFR Monitor
The monitor is intended to be used in conjunction with the Nova Max Creat eGFR Creatinine-Test Strips to measure creatinine and calculate estimated glomerular filtration rate (eGFR) using capillary whole blood obtained from the fingertip. The hand-held monitor is lightweight, portable, utilizes a 2.8" color touchscreen display and has capability for storage (400 test samples and/or quality control samples) and review of data. The monitor is powered by a rechargeable, 3.7 V Li polymer battery.

Nova Max Creat eGFR Creatinine-Test Strips
The Nova Max Creat eGFR Creatinine-Test Strip is designed with an electrode that measures creatinine levels. Creatinine in the capillary whole blood sample mixes with the reagents in the test strip to produce an electric current. The amount of current that is produced depends on how much creatinine is in the sample. A digital readout is displayed on the monitor in 30 seconds, the eGFR is calculated using patient information and the measured creatinine level. The test strips are for single use only.

Nova Max Creat eGFR Creatinine Control Solutions
The Nova Max Creat eGFR Creatinine Control Solution is used as a quality control check to ensure that the Nova Max Creat eGFR Monitor and the Nova Max Creat eGFR Creatinine-Test Strips are working properly as a system. There are two levels of Nova Max Creat eGFR Creatinine Control Solution. Each level of control solution has a known creatinine concentration that reacts with the reagents in the test strip.

N/A

Ask a specific question about this device

The MiniMed 780G insulin 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 MiniMed 780G insulin 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 MiniMed 780G insulin pump contains a bolus calculator that calculates an insulin dose based on user-entered data.

The MiniMed 780G insulin pump is indicated for use in individuals 7 years of age and older.

The MiniMed 780G insulin pump is intended for single patient use and requires a prescription.

The MiniMed 780G insulin pump ("780G ACE Pump") is an alternate controller enabled (ACE) pump intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. It can reliably and securely communicate with compatible digitally connected devices, including an integrated continuous glucose monitor (iCGM), interoperable Medtronic continuous glucose monitor (CGM), and interoperable automated glycemic controller (iAGC). The pump is intended to be used both alone and in conjunction with compatible, digitally connected medical devices for the purpose of drug delivery.

The 780G insulin pump is an ambulatory, battery-operated, rate-programmable micro-infusion pump that contains pump software and houses electronics, a pumping mechanism, a user interface, and a medication reservoir within the same physical device. The pump also contains a bolus calculator that calculates an insulin dose based on user-entered data. It is comprised of several discrete external and internal components including a pump case made of a polycarbonate blend, an electronic printed circuit board assembly stacks and a drive motor system.

The 780G Pump is an interoperable device that can communicate via a Bluetooth Low Energy (BLE) wireless electronic interface with digitally connected devices. The 780G pump is a host device for the iAGC and integrates iAGC algorithm into the pump firmware. The pump is then able to receive, execute, and confirm commands from an iAGC to adjust delivery of insulin. The pump receives sensor glucose (SG) data via BLE interface from a compatible iCGM or a compatible interoperable Medtronic CGM and transmits these CGM data to the embedded iAGCs.

The 780G pump can operate in one of two modes: Manual Mode or Auto Mode (also referred to as "SmartGuard Mode"). The pump provides the user with keypad pump controls, as well as a data screen for configuring therapy settings and viewing continuous real-time glucose values, glucose trends, alerts, alarms, and other information. The user interface and alerts provide the user with the ability to interact with the pump delivery system and digitally connected devices.

The provided FDA 510(k) clearance letter and summary for the MiniMed 780G Insulin Pump (K253470) do not contain the detailed information required to fill out all requested sections of the acceptance criteria and study design. This document focuses on demonstrating substantial equivalence to a predicate device and fulfilling regulatory requirements, rather than providing a detailed clinical study report suitable for assessing device performance against specific, quantifiable acceptance criteria in the manner requested.

However, based on the provided text, I can extract and infer some information, and note where specific details are missing.

Here's an attempt to answer your request based on the provided text:

Acceptance Criteria and Device Performance for MiniMed 780G Insulin Pump

The provided FDA 510(k) summary extensively references compliance with regulatory standards and performance compared to predicate devices, particularly for "Delivery Volume Accuracy" and "Bolus Delivery Accuracy" which specify numerical criteria. Other performance aspects are described more qualitatively as meeting requirements or demonstrating safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified in the provided document. The document refers to various "testing" and "verification activities" but does not detail the sample sizes for these tests (e.g., number of pumps, number of test cycles, number of patients, etc.).
• Data Provenance: The studies appear to be pre-market, non-clinical bench testing conducted by the manufacturer, Medtronic MiniMed, Inc. There is no indication of clinical study data or geographical origin of patient data (e.g., country of origin) as this particular submission focuses on the device and not a clinical study of its use. Many tests refer back to the predicate device (K251032).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable / Not Specified. The document describes non-clinical performance and engineering validation tests (e.g., accuracy, stability, cybersecurity, human factors). These types of tests typically rely on objective measurements against engineering specifications or regulatory requirements, rather than expert-established ground truth in the context of diagnostic interpretation. Human Factors validation involved intended users but the details about "experts" to establish a ground truth in a diagnostic sense are not present.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable / None Specified. This methodology (e.g., 2+1, 3+1 for clinical adjudication) is used for establishing ground truth in diagnostic studies, typically when evaluating algorithmic performance against human interpretation. The provided text describes engineering and regulatory compliance testing where such adjudication methods are not typically employed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. The provided text does not describe an MRMC comparative effectiveness study. This device is an insulin pump, not a diagnostic imaging AI system assisting human readers. The human factors validation is a separate type of study focusing on device usability and safety, not diagnostic performance improvement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Yes, implicitly for many aspects. Many of the tests described are standalone performance evaluations of the device, its firmware, and its capabilities without human intervention beyond setting up the test (e.g., Delivery Volume Accuracy, Catheter Occlusion Detection, Data Logging, Cybersecurity, Software Verification). The bolus calculator's operation within the pump would also be a standalone algorithmic function based on user input. The "Manual Mode" and "Auto Mode" imply different levels of automation, but the core technical tests are often standalone.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The type of "ground truth" varies by the specific test and is generally based on objective engineering and regulatory standards and reference methods.
  • Delivery Accuracy: Ground truth is the precisely measured or theoretical ideal insulin volume/rate against which the pump's actual delivery is compared.
  • Occlusion Detection: Ground truth would be the presence or absence of an occlusion under controlled test conditions.
  • Drug Stability/Compatibility: Ground truth is the chemical stability of insulin and the integrity of pump materials under test conditions.
  • Data Logging: Ground truth is the expected logging behavior as per design specifications and regulatory requirements.
  • Cybersecurity: Ground truth is the identified vulnerabilities and presence of effective mitigations.
  • Human Factors: Ground truth is the identification of safety-critical tasks and demonstration of safe and effective completion by intended users, often against predefined success criteria.

8. The sample size for the training set

• Not Specified / Not Applicable. The document does not describe a machine learning algorithm that undergoes a "training phase" with a specific dataset in the context of the device's development or regulatory submission. While the device contains firmware and potentially algorithms (like the iAGC algorithm embedded in the pump), the text focuses on verification and validation of the device itself against engineering specifications and regulatory controls, not the training of a learning algorithm. The iAGC is described as an embedded algorithm, but its training data or methodology are not part of this 510(k) summary.

9. How the ground truth for the training set was established

• Not Applicable. As no training set is described for a machine learning algorithm, the method for establishing its ground truth is not relevant to this document.

Ask a specific question about this device

SmartGuard technology is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible Medtronic continuous glucose monitors (CGMs), and alternate controller enabled (ACE) pumps to automatically adjust the delivery of basal insulin and to automatically deliver correction boluses based on sensor glucose values.

SmartGuard technology is intended for the management of Type 1 diabetes mellitus in persons 7 years of age and older, and of Type 2 diabetes mellitus in persons 18 years of age and older requiring insulin.

SmartGuard technology is intended for single patient use and requires a prescription.

Predictive Low Glucose technology is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible Medtronic continuous glucose monitors (CGMs), and alternate controller enabled (ACE) pumps to automatically suspend delivery of insulin when the sensor glucose value falls below or is predicted to fall below predefined threshold values.

Predictive Low Glucose technology is intended for the management of Type 1 diabetes mellitus in persons 7 years of age and older, and of Type 2 diabetes mellitus in persons 18 years of age and older requiring insulin.

Predictive Low Glucose technology is intended for single patient use and requires a prescription.

SmartGuard technology

SmartGuard technology, also referred to as Advanced Hybrid Closed Loop (AHCL) algorithm, is a software-only device intended for use by people with Type 1 diabetes, ages 7 years or older, and by people with Type 2 diabetes, ages 18 years or older. It is an interoperable automated glycemic controller (iAGC) that is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible interoperable Medtronic continuous glucose monitors (CGM) and compatible alternate controller enabled (ACE) pumps to automatically adjust the delivery of basal insulin and to automatically deliver correction boluses based on sensor glucose (SG) values.

The AHCL algorithm resides on the compatible ACE pump, which serves as the host device. It is meant to be integrated in a compatible ACE pump and is an embedded part of the ACE pump firmware.

Inputs to the AHCL algorithm (e.g., SG values, user inputs) are received from the ACE pump (host device), and outputs from the AHCL algorithm (e.g., insulin delivery commands) are sent by the algorithm to the ACE pump. As an embedded part of the firmware, the AHCL algorithm does not connect to or receive data from compatible CGMs; instead, sensor glucose (SG) values or other inputs received by the ACE pump from compatible CGMs via Bluetooth Low Energy (BLE) technology are transmitted to the embedded AHCL algorithm.

The AHCL algorithm works in conjunction with the ACE pump and is responsible for controlling insulin delivery when the ACE pump is in Auto Mode. It includes adaptive control algorithms that autonomously and continually adapt to the ever-changing insulin requirements of each individual.

The AHCL algorithm requires specific therapy settings (target setpoint, insulin-to-carb ratios and active insulin time) that need to be established with the help of a health care provider (HCP) before activation. It also requires five (5) consecutive hours of insulin delivery history, a minimum of two (2) days of total daily dose (TDD) of insulin, a valid sensor glucose (SG) and blood glucose (BG) values to start automated insulin delivery.

When activated, the AHCL algorithm adjusts the insulin dose at five-minute intervals based on CGM data. A basal insulin dose (auto basal) is commanded by the AHCL algorithm to manage glucose levels to the user's target setpoint of 100 mg/dL, 110 mg/dL or 120 mg/dL. The user can also set a temporary target of 150 mg/dL for up to 24 hours. In addition, under certain conditions the algorithm can also automatically command correction boluses (auto correction bolus) without user input.

Meal boluses are the responsibility of the user. The AHCL algorithm includes an integrated bolus calculation feature for user-initiated boluses for meals. When the user inputs their carbohydrate intake, the AHCL algorithm automatically calculates a bolus amount based off available glucose information, entered carbohydrate amount and other patient parameters.

The AHCL algorithm contains several layers of "safeguards" (mitigations) to provide protection against over-delivery or under-delivery of insulin to reduce risk of hypoglycemia and hyperglycemia, respectively.

The AHCL algorithm is a software-only device and does not have a user interface (UI). The compatible ACE pump provides a UI to the user to configure the therapy settings and interact with the algorithm. The AHCL-related alerts/alarms are displayed and managed by the pump.

Predictive Low Glucose technology

Predictive Low Glucose technology, also referred to as the Predictive Low Glucose Management (PLGM) algorithm is a software-only device intended for use by people with Type 1 diabetes, ages 7 years or older, and by people with Type 2 diabetes, ages 18 years or older. It is an interoperable automated glycemic controller (iAGC) that is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible interoperable Medtronic continuous glucose monitors (CGM) and compatible alternate controller enabled (ACE) pumps to automatically suspend delivery of insulin when the sensor glucose value falls below or is predicted to fall below predefined threshold values.

The PLGM algorithm resides on the compatible ACE Pump, which serves as the host device. It is meant to be integrated in a compatible ACE pump and is an embedded part of the ACE pump firmware.

Inputs to PLGM algorithm (e.g., sensor glucose values, user inputs) are received from the ACE pump (host device), and outputs from PLGM algorithm (e.g., suspend/resume commands) are sent by the algorithm to the ACE pump. As an embedded part of the ACE pump firmware, the PLGM algorithm does not connect to or receive data from compatible CGMs; instead, sensor glucose (SG) values or other inputs are received by the ACE pump from compatible CGMs via Bluetooth Low Energy (BLE) technology are transmitted to the embedded PLGM algorithm.

The PLGM algorithm works in conjunction with the ACE pump. When enabled, the PLGM algorithm is able to suspend insulin delivery for a minimum of 30 minutes and for a maximum of 2 hours based on current or predicted sensor glucose values. It will automatically resume insulin delivery when maximum suspend time of 2 hours has elapsed or when underlying conditions resolve. The user is also able to manually resume insulin at any time.

The PLGM algorithm is a software-only device and does not have a user interface (UI). The compatible ACE pump provides the UI to configure therapy settings and interact with the algorithm. The PLGM-related alerts/alarms are displayed and managed by the pump.

The provided FDA 510(k) clearance letter and summary concern the Medtronic SmartGuard Technology (Advanced Hybrid Closed Loop algorithm, AHCL) and Predictive Low Glucose Technology (Predictive Low Glucose Management algorithm, PLGM). The document details the devices' descriptions, indications for use, comparison to predicate devices, and summaries of non-clinical and clinical performance data.

However, it's important to note that this document primarily focuses on establishing substantial equivalence to previously cleared predicate devices and does not explicitly state specific acceptance criteria (performance targets) for clinical efficacy metrics (e.g., specific HbA1c reduction percentages or time in range targets needed for clearance) and does not present the study results in a direct "acceptance criteria vs. reported performance" table format for those specific targets. Instead, it highlights that the clinical data "confirmed the safety and effectiveness" and "demonstrated improved glycemic outcomes" or "non-inferiority," and that "the results also confirm that use...was associated with improved glucose control."

The document also provides details about the clinical studies without explicitly labelling them as "the study that proves the device meets the acceptance criteria" in the way a clinical trial protocol would specify primary and secondary endpoints and their statistical targets. Instead, it justifies substantial equivalence through the provided study data.

Therefore, the response below will extract the most relevant information based on your request, presenting the outcomes demonstrated by the studies as "reported device performance" where specific metrics are given, and noting the absence of explicit, pre-defined acceptance criteria targets in the clearance letter itself.

Acceptance Criteria and Study to Prove Device Meets Criteria

The FDA 510(k) summary for Medtronic's SmartGuard Technology and Predictive Low Glucose Technology establishes substantial equivalence to predicate devices. While the document asserts the safety and effectiveness, it does not explicitly define quantitative "acceptance criteria" for specific performance metrics in a pass/fail sense within this summary. Instead, it relies on demonstrating improved or non-inferior clinical outcomes compared to baseline or predicate performance. The clinical studies described confirm the safety and effectiveness and demonstrate associations with improved glucose control, which implicitly means the performance was deemed acceptable by the FDA for substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As explicit quantitative acceptance criteria (e.g., "HbA1c must reduce by X%") are not stated in this 510(k) summary, the table below presents the demonstrated clinical outcomes as "Reported Device Performance" highlighting the positive findings that supported clearance.

2. Sample Sizes Used for the Test Set and Data Provenance

The primary "test sets" for clinical effectiveness and safety were the patient cohorts in the described clinical studies.

• AHCL with Simplera Sync CGM (Type 1 Diabetes): The sample size details for this study (originally in K251217) are not explicitly provided in this 510(k) summary. However, it confirmed safety and effectiveness in Type 1 Diabetes patients.
• AHCL with Simplera Sync CGM & Guardian 4 CGM (Type 2 Diabetes) (P160017/S124):
  • Phase 1 (Guardian 4 CGM): N = 95 subjects.
  • Phase 2 (Simplera Sync sensor): N = 302 subjects (66 "transition", 236 "naive").
  • Data Provenance: Multi-center, single-arm study. The document does not specify countries but implies clinical trial settings. Given the general nature of FDA submissions, it would typically involve US-based and possibly international sites. Clinical data is generally considered prospective for such trials.
• AHCL with Guardian 4 CGM and Lyumjev Insulin (Type 1 Diabetes) (P160017/S125):
  • ITT Population: N = 101 (Age 7-17 Years), N = 110 (Age 18-80 Years).
  • Data Provenance: Single-arm, multi-center, home clinical investigation. The document does not specify countries but implies clinical trial settings. Prospective.
• AHCL with Guardian 4 CGM and Fiasp Insulin (Type 1 Diabetes) (P160017/S125):
  • ITT Population: N = 107 (Age 7-17 Years), N = 116 (Age 18-80 Years).
  • Data Provenance: Global multi-center, single-arm study. Countries mentioned: Australia, Canada, United States. Prospective.
• PLGM Algorithm: Evaluated for safety in a multi-center, single-arm, in-clinic study of the MiniMed 640G System. The sample size for this study (originally in K251217) is not explicitly provided in this 510(k) summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document refers to "clinical data" and "multi-center, single-arm studies" involving patients. For automated glycemic control devices, the "ground truth" for glucose values is typically established by laboratory reference methods (e.g., YSI glucose analyzer) performed by trained clinical staff as part of the study protocol, not by experts determining a ground truth in the interpretative sense. The efficacy endpoints (HbA1c, Time in Range, hypoglycemia) are derived from objective measurements, not subjective expert assessment of an image or signal.

There is no mention of "experts" in the context of establishing ground truth for glucose values or clinical outcomes. Clinical trials are monitored by clinical investigators (physicians, endocrinologists) and their teams, who ensure data integrity and protocol adherence, but they are not establishing a "ground truth" in the way radiologists might for AI image analysis.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where subjective interpretation is involved, such as in reading medical images. For automated glycemic control devices, clinical outcomes are based on objective measurements (e.g., sensor glucose, lab-measured HbA1c). Therefore, the concept of an adjudication method as described does not directly apply to the clinical performance data presented here. Device-related adverse events would be reported and reviewed by the study investigators and likely an independent Data Safety Monitoring Board (DSMB), but this isn't an "adjudication method" for the primary clinical endpoints. The document does not explicitly describe an adjudication method for the objective clinical endpoints.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. MRMC studies are typically used to evaluate the performance of diagnostic devices or AI algorithms that assist human readers (e.g., radiologists interpreting images). The SmartGuard and PLGM technologies are automated insulin delivery algorithms, not diagnostic tools that human readers interpret. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" does not apply here. The studies evaluate the algorithm's direct impact on glycemic control in patients.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Yes, the core of the evaluation involves the "standalone" or "algorithm-only" performance in controlling glucose levels. The AHCL algorithm automatically adjusts basal insulin delivery and delivers correction boluses. The PLGM algorithm automatically suspends insulin delivery. While these systems require user input for meal boluses and setup, and interaction with alerts/alarms, the "SmartGuard technology" and "Predictive Low Glucose technology" themselves are software algorithms that function autonomously based on sensor glucose values to manage insulin delivery. The clinical studies assess the efficacy and safety of these algorithms in action within the device system (pump + CGM).

7. Type of Ground Truth Used

The ground truth for evaluating device performance in these studies is based on objective clinical measurements and patient outcomes. Specifically:

• Continuous Glucose Monitoring (CGM) sensor values: These are the primary input to the algorithm. While not explicitly stated as the ground truth for the algorithm's inputs, the accuracy of these values is critical and would have been established independently for the compatible CGMs.
• Laboratory-measured HbA1c: A standard clinical biomarker for average blood glucose over 2-3 months.
• Time-in-Range (TIR): Percentage of time spent with sensor glucose values within a target range (e.g., 70-180 mg/dL), derived from CGM data.
• Time-below-range (TBR): Percentage of time spent with sensor glucose values below a predefined threshold (e.g., <70 mg/dL), derived from CGM data.
• Adverse Events (AEs) and Serious Adverse Events (SAEs): Collected during clinical trials to assess safety.

These are physiological and clinical outcome data, not expert consensus or pathology reports in the typical sense.

8. The Sample Size for the Training Set

The document does not provide details on the sample size used for training the algorithm. This 510(k) summary focuses on the clinical data for validation of the finalized algorithms. The training set would be data used during the development phase of the algorithms, which is typically proprietary and not disclosed in 510(k) summaries. It would likely involve a large dataset of glucose profiles and insulin delivery patterns.

9. How the Ground Truth for the Training Set Was Established

Similarly, the document does not describe how the ground truth for the training set was established. For algorithms predicting glucose or controlling insulin, development and training would typically rely on:

• Retrospective or prospective real-world glucose and insulin data: Collected from individuals with diabetes using CGMs and insulin pumps, potentially under controlled conditions or in free-living settings.
• Validated glucose measurements: Such as YSI or other reference laboratory methods for blood glucose, and accurate CGM data.
• Clinical expert knowledge: Incorporating understanding of diabetes physiology, insulin pharmacokinetics/pharmacodynamics, and desired glycemic targets.
• Mathematical models of glucose metabolism: To simulate physiological responses and generate synthetic data for training.

The ground truth would be the actual glucose values and the physiological responses to insulin delivery, enabling the algorithm to learn patterns and predict future glucose trends or optimal insulin dosing.

Ask a specific question about this device

The Core Metabolic panel is part of the TruWellness Panel™ and is intended for use on the TruVerus™. The Core Metabolic panel (part of the TruWellness Panel™) is an in vitro diagnostic device and intended to be used for the quantitative determination of Glucose (GLU), Total Protein (TP), and Albumin (ALB) in lithium-heparinized venous whole blood in clinical laboratory or point-of-care settings.

The Core Metabolic panel (part of the TruWellness Panel™) is an in vitro diagnostic test system that aids the physician in the diagnosis and treatment of the following disorders in adults 18 years of age or older:

• Glucose (GLU): Carbohydrate metabolism disorders, including diabetes mellitus, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
• Total Protein (TP): Variety of diseases involving the liver, kidney, or bone marrow, as well as other metabolic and nutritional disorders.
• Albumin (ALB): Numerous diseases involving primarily the liver and kidneys.

The TruSystem is an automated, integrated in vitro diagnostic platform consisting of the TruVerus™ and 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 Single-Use Consumable Kit (TruWellness Panel™) houses all the components needed to process as well as analyze samples on the TruVerus™, 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 Core Metabolic panel is part of the TruWellness Panel™ and is intended for use on the TruVerus™. The Core Metabolic panel (part of the TruWellness Panel™) is intended for in vitro quantitative determination of Glucose (GLU), Total Protein (TP), and Albumin (ALB) in lithium-heparinized venous whole blood samples.

N/A

Ask a specific question about this device

The Nova Allegro urine albumin creatinine ratio (UACR) assay is intended for the quantitative determination of albumin, creatinine, and the albumin/creatinine ratio (UACR) in human urine. The measurement of urine albumin, creatinine, and albumin/creatinine ratio aids in the early diagnosis of nephropathy.

The Nova Allegro Analyzer is intended for in vitro diagnostic use in clinical laboratory and near-patient testing (point-of-care) settings for the quantitative determination of Nova Allegro Assays using Nova Allegro Test Cartridges.

Nova Allegro UACR Assay

The Nova Allegro UACR Assay is a completely automated assay that functions with the Nova Allegro Analyzer for the determination of albumin and creatinine and the calculation of UACR in human urine. The Nova Allegro UACR Assays are performed sequentially using a single Allegro UACR test cartridge. The Allegro UACR Test Cartridge contains all of the reagents for measuring albumin and creatinine. Allegro UACR Controls are used to monitor the performance of the Nova Allegro UACR Test Cartridge and Allegro analyzer.

Nova Allegro Analyzer

The Nova Allegro Analyzer is a compact, point-of-care analyzer that features a clinically important menu of measured and calculated tests. All tests are measured with disposable, ready-to-use cartridges. The analyzer supports multiple wavelengths that are used to measure the assay of interest. The analyzer consists of the following key systems/components that the user interacts with:

• Two analytical bays where the single use test cartridges are analyzed
• Color Touchscreen Display
• Barcode Scanner
• Printer
• Data Export Options
• Ethernet Connection
• USB Port

N/A

Ask a specific question about this device