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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 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

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.,

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