Nova Allegro UACR Assay, Nova Allegro Analyzer

K252206 · Nova Biomedical Corporation · CGX · Jan 9, 2026 · Clinical Chemistry

Device Facts

• Record ID: K252206
• Device Name: Nova Allegro UACR Assay, Nova Allegro Analyzer
• Applicant: Nova Biomedical Corporation
• Product Code: CGX · Clinical Chemistry
• Decision Date: Jan 9, 2026
• Decision: SESE
• Submission Type: Dual Track
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

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.

Device Story

Nova Allegro UACR Assay and Analyzer system performs quantitative urine albumin and creatinine analysis. System uses immunoturbidimetric method for albumin and colorimetric method for creatinine. User collects urine sample via single-use capillary device, loads onto test cartridge, and inserts into analyzer. Modification adds integrated Allegro Sample Volume Verification System to ensure correct sample volume. Analyzer processes sample and provides quantitative results to healthcare provider for nephropathy diagnosis. Used in clinical labs and point-of-care settings by professional users.

Clinical Evidence

No clinical data provided. Analytical performance, precision, linearity, specificity, and method comparison were previously established in K221813. Bench testing confirmed the effectiveness of the new Sample Volume Verification System.

Technological Characteristics

System utilizes immunoturbidimetric and colorimetric assays. Features integrated Allegro Sample Volume Verification System. Designed for professional use in clinical/point-of-care settings. Complies with ISO 14971 (risk management) and IEC 62304 (software life cycle).

Indications for Use

Indicated for quantitative determination of albumin, creatinine, and UACR in human urine to aid in early diagnosis of nephropathy. Intended for professional use in clinical laboratory and point-of-care settings.

Regulatory Classification

Identification

A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Predicate Devices

• Nova Allegro UACR Assay, Nova Allegro Analyzer (K221813)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY AND INSTRUMENT

## I Background Information:

A 510(k) Number

K252206

B Applicant

Nova Biomedical Corporation

C Proprietary and Established Names

Nova Allegro UACR Assay, Nova Allegro Analyzer

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| CGX | Class II | 21 CFR 862.1225 - Creatinine Test System | CH - Clinical Chemistry |
| JIQ | Class I, meets the limitations of exemptions in 862.9(c)(9) | 21 CFR 862.1645 - Urinary protein or albumin (nonquantitative) test system | CH - Clinical Chemistry |
| JQT | Class I | 21 CFR 862.2400 – Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use | CH- Clinical Chemistry |

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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## II Submission/Device Overview:

A Purpose for Submission:
Modification to a cleared device

B Measurand:
Urine Albumin and Creatinine

C Type of Test:
Immunoturbidimetric (Albumin)
Colorimetric (Creatinine)

## III Intended Use/Indications for Use:

A Intended Use(s):
See Indications for Use below.

B Indication(s) 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.

C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only

D Special Instrument Requirements:
Nova Allegro Analyzer

## IV Device/System Characteristics:

A Device Description:
The assay is unchanged since it was cleared in K221813.

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The instrument cleared in K221813 was modified to include a control feature to ensure the correct sample volume.

## B Principle of Operation:
Same as described in K221813.

## C Instrument Description Information:

1. Instrument Name:
Same as K221813.

2. Specimen Identification:
Same as described in K221813.

3. Specimen Sampling and Handling:
A single-use, disposable capillary sample collection device is used to obtain and load the sample. The capillary sample collection device containing the sample is loaded onto the test cartridge, then the test cartridge is placed into the sample bay within 1 minute of sample collection and the start icon is pressed to start analysis. For the UACR assay, the instrument has a control feature, an integrated Allegro Sample Volume Verification System to ensure the correct sample volume.

4. Calibration:
Same as described in K221813.

5. Quality Control:
Same as described in K221813.

## V Substantial Equivalence Information:

### A Predicate Device Name(s):
Nova Allegro UACR Assay, Nova Allegro Analyzer

### B Predicate 510(k) Number(s):
K221813

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C Comparison with Predicate(s):

| Device & Predicate Device(s): | K252206 | K221813 |
| --- | --- | --- |
| Device Trade Name | Nova Allegro UACR Assay, Nova Allegro Analyzer | Same |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | 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. | Same |
| Matrix | Urine | Same |
| Intended Users | Professional | Same |
| General Device Characteristic Differences | | |
| Sample Volume Verification System | Yes | No |

VI Standards/Guidance Documents Referenced:

- ISO 14971 Third Edition 2019-12. Medical Devices; Application of risk management to medical devices.
- IEC 62304 Edition 1.1 2015-06 Consolidated Version; Medical device software-Software life cycle processes.

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:
This was previously established in K221813.

2. Linearity:
This was previously established in K221813.

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3. Analytical Specificity/Interference:
This was previously established in K221813.

4. Assay Reportable Range:
This was previously established in K221813.

5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
This was previously established in K221813.

6. Detection Limit:
This was previously established in K221813.

7. Assay Cut-Off:
Not applicable

8. Accuracy (Instrument):
See K221326 Section VII.C.3 Other Clinical Supportive Data.

9. Carry-Over:
This was previously established in K221813.

B Comparison Studies:

1. Method Comparison with Predicate Device:
This was previously established in K221813.

2. Matrix Comparison:
Not Applicable

C Clinical Studies:

1. Clinical Sensitivity:
Not applicable

2. Clinical Specificity:
Not applicable

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3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):

Not applicable

D. Clinical Cut-Off:

Not applicable

E. Expected Values/Reference Range:

Same as described in K221813

F. Other Supportive Instrument Performance Characteristics Data:

Sample Volume Verification System

The sample volume verification system was tested and shown to be effective.

Information to support electrical safety and electromagnetic compatibility (EMC) software and cybersecurity was reviewed and found to be acceptable.

The Nova Allegro UACR Assay on the Nova Allegro Analyzer is not impacted by altitude up to 12,000 feet/3650 meters.

VIII. Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

IX. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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