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510(k) Data Aggregation

    K Number
    K221813
    Device Name
    Nova Allegro UACR Assay, Nova Allegro Analyzer
    Manufacturer
    Nova Biomedical Corporation
    Date Cleared
    2024-11-19

    (881 days)

    Product Code
    CGX,JIQ,JQT
    Regulation Number
    862.1225
    Type
    Dual Track
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K072409
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    Nova Allegro UACR Assay: The Nova Allegro UACR Assay is a completely automated assay for the determination of albumin and creatinine in human urine. The results are used to calculate the UACR (Urine Albumin to Creatinine Ratio). Nova Allegro UACR Test Cartridges are the key element a user interacts with to determine the albumin and creatinine levels in a human urine sample. The main components of the Test Cartridge are the Capillary, the reaction chamber, and the barcode label.

    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
    AI/ML Overview

    The provided text is a 510(k) Summary for the Nova Allegro UACR Assay and Analyzer. It details the device's performance testing results. According to the prompt's request, I will extract relevant information to describe the acceptance criteria and the study proving the device meets these criteria.

    It's important to note that this document describes a medical device, specifically an in-vitro diagnostic test, not an AI/ML-based device. Therefore, many of the requested fields related to AI/ML specific quality evaluation criteria, such as "number of experts used to establish ground truth," "adjudication method," "MRMC study," "effect size of human readers improving with AI," "standalone performance," and details about training sets/ground truth for training, are not applicable in this context. The study performed is a performance validation of a diagnostic assay, comparing its results to a comparative method (CM), not a reader study.

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

    Device: Nova Allegro UACR Assay, Nova Allegro Analyzer
    Indications for Use: 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.

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are generally implied by the successful conclusion of each test and the statement that the data "meets the acceptance criteria" or "demonstrated no significant interference." Specific quantitative acceptance criteria are sometimes stated (e.g., <10% difference for interference).

    Performance MetricAcceptance Criteria (Implied/Stated)Reported Device Performance
    LinearityData indicates the system reports linear albumin and creatinine test results across the reportable range when compared to the Comparative Method (CM). Expected to "meet the acceptance criteria."The linearity data met the acceptance criteria when compared to the CM. The data indicates that the Nova Allegro System reports linear albumin and creatinine test results using urine specimens across the reportable range.
    Hook EffectOccurrence above 5,000 mg/L (10 times higher than previously stated criteria in the document).The "Hook Effect" was determined to occur above 50,000 mg/L, meeting the acceptance criteria. This is 10 times higher than the acceptance criteria of 5,000 mg/L and approximately 167 times greater than the upper reportable measurement range for the assay.
    Detection LimitLOB, LOD, and LOQ for Albumin and Creatinine measurements must be below the lower limit of the claimed measurement range.The study demonstrates that the LOB, LOD, and LOQ results for Albumin and Creatinine measurements by the Nova Allegro UACR Assay are all below the lower limit of the claimed measurement range.
    InterferenceA test substance was considered to interfere if the absolute difference between the mean test value and the mean control value was greater than 10%.Most tested substances demonstrated no significant interference (greater than 10% effect). Specific interfering substances (Table 2) identified with their highest non-interfering concentrations. Urines with pH between 4.3 – 10.0 exhibited no interference (except low Albumin at pH 4.0). Specific gravity between 1.003 and 1.048 exhibited no clinical interference.
    Method ComparisonIndicated by "data supports the 510(k) substantial equivalence approval decisions." For albumin, creatinine, and UACR, linear regression analysis "r" values (correlation coefficients) close to 1 (e.g., ≥0.99) and slopes/intercepts indicative of close agreement with the CM.Albumin (ALL Combined): Slope = 0.983, Intercept = 0.858, r = 0.998. Sample range Allegro 5-300 mg/L.
    Creatinine (ALL Combined): Slope = 0.949, Intercept = 3.775, r = 0.997. Sample range Allegro 16-498 mg/dL.
    UACR (ALL Combined): Slope = 0.995, Intercept = 1.101, r = 0.997. Sample range Allegro 1-1592.
    Precision (Repeatability)Low %CV values (e.g., <5-10%) for mean concentrations across sites, indicating consistent results within a laboratory.Microalbumin: Overall %CV: Urine 1 (3.6%), Urine 2 (4.0%), Urine 3 (3.6%)
    Creatinine: Overall %CV: Urine 1 (4.0%), Urine 2 (3.1%), Urine 3 (3.4%)
    UACR: Overall %CV: Urine 1 (2.5%), Urine 2 (2.5%), Urine 3 (2.4%)
    Precision (Between Run/Operator)Low %CV values.Microalbumin: Overall %CV: Urine 1 (2.6%), Urine 2 (0.3%), Urine 3 (1.5%)
    Creatinine: Overall %CV: Urine 1 (2.3%), Urine 2 (0.5%), Urine 3 (2.7%) -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
    UACR: Overall %CV: Urine 1 (1.2%), Urine 2 (0.6%), Urine 3 (1.8%)
    Precision (Between Lot/Day)Low %CV values.Microalbumin: Overall %CV: Urine 1 (1.3%), Urine 2 (1.3%), Urine 3 (0.5%)
    Creatinine: Overall %CV: Urine 1 (1.0%), Urine 2 (0.5%), Urine 3 (0.5%)
    UACR: Overall %CV: Urine 1 (0.5%), Urine 2 (1.1%), Urine 3 (0.2%)
    Precision (Within Laboratory)Low %CV values across sites.Microalbumin: Overall %CV: Urine 1 (4.6%), Urine 2 (4.1%), Urine 3 (4.2%) ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
    Creatinine: Overall %CV: Urine 1 (4.8%), Urine 2 (3.4%), Urine 3 (4.5%)
    UACR: Overall %CV: Urine 1 (2.9%), Urine 2 (3.0%), Urine 3 (3.2%)
    Precision (Between Site)Low %CV values.Microalbumin: Overall %CV: Control 1 (1.0%), Control 2 (1.6%)
    Creatinine: Overall %CV: Control 1 (1.0%), Control 2 (0.9%) -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
    UACR: Overall %CV: Control 1 (1.2%), Control 2 (1.2%)

    2. Sample Size and Data Provenance

    • Test Set Sample Sizes:

      • Linearity Testing: Not explicitly stated as a number of patient samples, but involved "UACR control solutions (Level 1 & Level 2)" and "two (2) urine pools containing low and very high albumin and creatinine concentrations."
      • Hook Effect: Involved "both pooled urine specimens and calibrator matrix."
      • Detection Limit: Sixty (60) replicate measurements for LOB, thirty-six (36) replicate measurements for LOQ.
      • Interference Testing: Ten (10) replicate UACR tests were performed on prepared urine specimens per interfering substance.
      • Method Comparison: A total of 535 samples within the measurement range for Albumin (41 altered) and 653 samples within the measurement range for Creatinine (0 altered). For UACR, 531 samples were tested (41 altered). (Note: the number of altered vs. unaltered samples is specified. The altered samples are used to ensure coverage of the analytical measurement range).
      • Precision: Urine samples (3 levels) were tested in replicates over multiple days/runs at 4 sites. Specific numbers of replicates are indicated by the CLSI guidance used, but not explicitly enumerated per site/level in the summary beyond general study setup.

    • Data Provenance:

      • Country of Origin: Not explicitly stated in the summary.
      • Retrospective or Prospective: The "Point-of-Care (POC) Method Comparison studies on fresh urine specimens were conducted within four (4) different POC sites." This implies a prospective collection of samples during the study.

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

    • Not applicable for this type of diagnostic device performance study. Ground truth is established by a "Comparative Method" (CM), which is another established, legally marketed, and often more robust laboratory assay.
    • The "CM method" for albumin was the "Siemens Dimension EXL 200 Integrated Chemistry System utilizing Dimension® Flex® reagent cartridge MALB, Dimension calibrator cartridge MALB CAL (Traceable to IFCC International Reference Preparation for Plasma Proteins)."
    • The "CM method" for creatinine was "Dimension Flex Reagent Cartridge CRE2, and Dimension CHEM 1 CAL (Traceable to NIST SRM 914 and verified with NIST SRM 967)." These are reference laboratory methods, not human expert interpretations.

    4. Adjudication Method for the Test Set

    • None. This is a quantitative chemical assay, not an interpretative AI/ML system requiring human adjudication of ground truth labels. Comparison is made against a validated laboratory reference method.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs. without AI assistance

    • Not applicable. This is not an AI/ML-based device that assists human readers. It is a standalone diagnostic test for laboratory and point-of-care use.

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

    • Yes, this is a standalone device. The Nova Allegro Analyzer and UACR Assay provides quantitative results directly. Its performance is validated against a comparative method in a standalone manner. The "human-in-the-loop" here is the operator running the test, not an interpretive role.

    7. The Type of Ground Truth Used

    • Comparative Method / Reference Method: The ground truth for the "Method Comparison" study was established using the Siemens Dimension EXL 200 Integrated Chemistry System, which served as the reference standard (CM method). This system's calibration is traceable to international reference preparations (IFCC) and NIST standards.

    8. The Sample Size for the Training Set

    • Not applicable. As an in-vitro diagnostic device, this product does not involve machine learning or AI models that require a "training set." Its analytical performance is based on established chemical and immunoturbidimetric principles, validated through traditional analytical and clinical performance studies, not algorithmic training data.

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

    • Not applicable. See point 8.
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