Nova Allegro UACR Assay, Nova Allegro Analyzer
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K221813 FDA 510(k)
- FDA Product Code
- CGX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1225 FDA 510(k)
- Regulation Number
- 862.1225 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Nova Allegro UACR Assay is an in vitro diagnostic device designed for the quantitative determination of urine albumin, creatinine, and the albumin-to-creatinine ratio (UACR). It falls under the category of clinical chemistry assays, utilizing colorimetric methods for biochemical analysis to support nephropathy screening and early diagnosis.
This system is intended for use in clinical laboratories and point-of-care settings, employing disposable test cartridges for capillary blood or urine samples. The Nova Allegro Analyzer operates as a compact, user-friendly device suitable for non-technical staff, with no requirement for venipuncture. It has received FDA 510(k) clearance under the Dual Track review process, classified as a Class II device under regulation 862.1225.
Frequently asked questions
What clinical conditions is the Nova Allegro UACR Assay primarily used to evaluate or monitor?
The Nova Allegro UACR Assay is designed for quantitative measurement of urine albumin, creatinine, and the albumin-to-creatinine ratio (UACR), which are key markers for assessing kidney function and detecting early signs of nephropathy. By providing these measurements, it supports screening and early diagnosis of conditions like diabetic nephropathy and other forms of chronic kidney disease.
Is the Nova Allegro Analyzer suitable for use in non-laboratory settings, such as point-of-care environments?
Yes, the Nova Allegro Analyzer is explicitly designed for use in both clinical laboratories and point-of-care settings. Its compact, user-friendly design makes it accessible for non-technical staff, and it does not require venipuncture, simplifying sample collection for urine analysis. This makes it practical for settings where rapid, on-site testing is beneficial.
How are samples analyzed on the Nova Allegro Analyzer, and what type of samples does it accept?
The Nova Allegro Analyzer uses disposable test cartridges to perform colorimetric biochemical analysis. It is specifically designed to analyze urine samples, measuring albumin, creatinine, and the albumin-to-creatinine ratio (UACR) without requiring capillary blood samples. This streamlines workflows for nephrology assessments.
What is the regulatory pathway for the Nova Allegro UACR Assay, and what does this mean for its use?
The Nova Allegro UACR Assay has received FDA 510(k) clearance under the Dual Track review process, classifying it as a Class II device under regulation 862.1225. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device, ensuring it meets applicable safety and performance standards for clinical chemistry assays in the U.S. market.
Are the test cartridges for the Nova Allegro Analyzer single-use, and if so, does this affect their storage requirements?
The Nova Allegro Analyzer uses disposable test cartridges, which are intended for single-use only. While the device data does not specify storage conditions for the cartridges, single-use disposables typically require protection from contamination, extreme temperatures, and moisture to maintain accuracy and sterility until use. Always follow manufacturer guidelines for optimal storage.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Nova Allegro UACR Assay, Nova Allegro Analyzer (K221813) — FDA 510(k ..., Allegro® Capillary Blood Analyzer | Nova Biomedical, PDF K221813.508DecisionSummary.FINAL
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221813 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nova Biomedical Corporation
Sources (1)
- FDA 510(k) K221813 24 fields · synced Sep 19, 2026