Nova Allegro UACR Assay, Nova Allegro Analyzer
Device Facts
| Record ID | K221813 |
|---|---|
| Device Name | Nova Allegro UACR Assay, Nova Allegro Analyzer |
| Applicant | Nova Biomedical Corporation |
| Product Code | CGX · Clinical Chemistry |
| Decision Date | Nov 19, 2024 |
| 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; point-of-care diagnostic tool for nephropathy screening. Inputs: human urine samples (no preservative) applied to disposable, ready-to-use test cartridges. Operation: analyzer features two analytical bays; uses immunoturbidimetric measurement for albumin (antibody-specific complex formation) and Benedict/Behre chemistry for creatinine (3,5-dinitrobenzoic acid at high pH). Outputs: quantitative albumin, creatinine, and calculated UACR displayed on color touchscreen. System includes barcode scanner, printer, and data export (USB/Ethernet). Used by clinicians in labs or point-of-care settings. Output aids clinical decision-making regarding early nephropathy diagnosis. Benefits: rapid, automated, quantitative assessment of kidney health markers.
Clinical Evidence
Bench testing only. Precision/reproducibility assessed across 4 sites with 12 operators over 20 days (overall CVs 0.2%–4.8%). Linearity validated across reportable ranges (Albumin 5–300 mg/L; Creatinine 15–500 mg/dL). Interference testing performed per CLSI EP07-A3; significant interference identified for specific substances (e.g., oxalic acid, bilirubin, riboflavin). Method comparison (n=659) against Siemens Dimension EXL 200 showed strong correlation (Albumin slope 0.98; Creatinine slope 0.95; UACR slope 0.99).
Technological Characteristics
System consists of a compact analyzer and disposable test cartridges. Albumin measurement: immunoturbidimetric; Creatinine measurement: alkaline colorimetric (Benedict/Behre). Connectivity: Ethernet, USB. User interface: color touchscreen, barcode scanner, integrated printer. Calibration: built-in. Software: automated analysis of optical measurements.
Indications for Use
Indicated for quantitative determination of albumin, creatinine, and albumin/creatinine ratio in human urine to aid in early diagnosis of nephropathy. Intended for use in clinical laboratory and point-of-care settings by professional users (prescription use).
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
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
K221813
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 | 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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K221813 - Page 2 of 13
## II Submission/Device Overview:
A Purpose for Submission:
New Device
B Measurand:
Urine Albumin and Creatinine
C Type of Test:
Immunoturbidimetric (Albumin)
Colorometric (Creatinine)
## III Intended Use/Indications for Use:
A Intended Use(s):
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.
B Indication(s) for Use:
See Intended Use above.
C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
D Special Instrument Requirements:
The UACR Assay is used with the Nova Allegro Analyzer.
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## IV Device/System Characteristics:
### A Device Description:
#### Nova Allegro UACR Assay
The Allegro UACR Assay measures Albumin and Creatinine in human urine. The UACR is calculated by the Allegro Analyzer. The Allegro UACR Test Cartridge contains all of the reagents for measuring albumin and creatinine.
#### Cartridge Description:
The main components of the Test Cartridge are the Capillary, the reaction chamber, and the barcode label.
The Allegro UACR test cartridge contains 3 reagent solutions as described in the following table:
| Sample Diluent | 0.2% w/v 3,5-dinitrobenzoic acid, 4% polyethylene glycol in 100 mM tris buffer, pH 7.5, 150 mM NaCl, with 2.5% other ingredients (stabilizers, preservatives) (350 μL per cartridge) |
| --- | --- |
| Albumin Reagent | 10 – 15 mg/mL delipidated goat IgG fraction containing anti-human albumin in 50 mM Tris, 150 mM NaCl with 2.2% other ingredients (stabilizers, preservatives) (105 μL per cartridge) |
| Creatinine Reagent | 15% potassium hydroxide, 0.5M dipotassium hydrogen phosphate, with 2% other ingredients (stabilizers, preservatives). (120 μL per cartridge). |
#### Nova Allegro Analyzer
The Nova Allegro Analyzer is a compact, point-of-care analyzer. 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
### B Principle of Operation:
The Allegro UACR Test Cartridge contains all reagents required for measuring albumin and creatinine. When a human urine sample is introduced into a Test Cartridge by a capillary, albumin present in a urine sample reacts with antibody specific against human albumin and antibody-albumin complex is formed resulting in turbidity increase measured by absorbance at
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405 nm. The amount of complex is in direct proportion to the amount of albumin in the sample. The albumin is then quantified using a calibration curve.
The Benedict/Behre chemistry is the basis for the creatinine assay. 3,5-dinitrobenzoic acid at high pH reacts with creatinine to form a colored complex at 530 nm. The colored complex is in direct proportion to the amount of creatinine in the sample which is determined from a stored calibration curve. The albumin to creatinine ratio, UACR, is then calculated and displayed on the Nova Allegro Analyzer.
## C Instrument Description Information:
1. Instrument Name:
Nova Allegro Analyzer
2. Specimen Identification:
Specimen identification can be done by scanning a patient identification bar code or by manual entry.
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.
4. Calibration:
The reagent test cartridge includes a scannable 2D barcode containing the stored calibration curve.
5. Quality Control:
External Quality Control (QC) material is used to monitor the performance of the analyzer and the test cartridges used with the analyzer and to verify the analyzer is performing to specifications. QC recommendations are found in the labeling.
## V Substantial Equivalence Information:
A Predicate Device Name(s):
Afinion ACR and Afinion ACR Control, Afinion 2 analyzer
B Predicate 510(k) Number(s):
K072409, K171650
K221813 - Page 4 of 13
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# C Comparison with Predicate(s):
| Device & Predicate Device(s): | K221813 | Predicate |
| --- | --- | --- |
| Device Trade Name | Nova Allegro UACR Assay | Afinion ACR and Afinion ACR Control |
| 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 | | |
| Measurement Range - Albumin | 5-300 mg/L | 5-200 mg/L |
| Measurement Range - Creatinine | 15-500 mg/dL | 16.4 - 339.9 mg/dL |
| Measurement Range - ACR | 1-2000 mg/g | 1 - 1250 mg/g |
| Test Principle - Albumin | Immunoturbidimetric measurement | Immunometric membrane flow-through principle |
| Test Principle - Creatinine | Benedict/Behre (non enzymatic) alkaline colorimetric | Enzyme Colorimetric |
| Sample Volume | 25 μL | 3.5 μL |
| Device & Predicate Device(s): | K221813 | K171650 |
| --- | --- | --- |
| Device Trade Name | Nova Allegro Analyzer | Afinion 2 analyzer |
| General Device Characteristic Similarities | | |
K221813 - Page 5 of 13
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| Intended Use/Indications For Use | For in vitro diagnostic use for the quantitative determination of assays using test cartridges. | Same |
| --- | --- | --- |
| General Device Characteristic Differences | | |
| Cartridge Interface | Physical processing of cartridge (locking, docking, foil penetration, mixing assay) | Physical processing of cartridge (locking, docking, splitting, foil penetration, merging) |
| Peripheral units | Barcode reader and printer integrated into analyzer | A barcode reader and printer can be connected |
VI Standards/Guidance Documents Referenced:
- CLSI Guideline "Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guidelines – Third Edition", CLSI EP5-A3
- CLSI Guideline, "Evaluation of the Linearity of Quantitative Measurement Procedures", EP06-Ed2
- Interference Testing in Clinical Chemistry; Approved Guideline -Third Edition: CLSI EP07-A3
- CLSI "Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline – Third Edition", CLSI EP09c
VII Performance Characteristics (if/when applicable):
A Analytical Performance:
1. Precision/Reproducibility:
Measures of Imprecision for the Nova Allegro UACR Assay were assessed using methods described in CLSI "Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guidelines – Second Edition", CLSI EP5-A3 as guidance.
A total of 8 Nova Biomedical Allegro Analyzers (2 per site) and 3 lots of Allegro UACR Test Cartridges were used in the study.
Precision studies were conducted at four different sites with 12 operators. At each of the 4 sites, 3 operators ran 2 levels of quality control material (UACR Control Solution Level 1 and UACR Control Solution Level 2) and 3 levels of urine specimens four times a day, twice in the morning and twice in the afternoon, for 20 days to obtain 80 data points per level.
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Repeatability
| Urine Samples | Site 1 | | Site 2 | | Site 3 | | Site 4 | | Overall | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | Mean | SD | Mean | SD | Mean | SD | Mean | SD | Mean | SD | % CV |
| 1 | ALB | 125 | 4.4 | 125 | 4.5 | 124 | 5.0 | 120 | 4.0 | 123 | 4.5 | 3.6% |
| | CRE | 62 | 2.2 | 61 | 2.4 | 59 | 2.9 | 59 | 2.2 | 60 | 2.4 | 4.0% |
| | ACR | 202 | 4.2 | 203 | 5.5 | 210 | 5.0 | 202 | 5.5 | 204 | 5.1 | 2.5% |
| 2 | ALB | 134 | 5.1 | 131 | 5.9 | 131 | 4.8 | 130 | 5.1 | 131 | 5.3 | 4.0% |
| | CRE | 460 | 13.2 | 453 | 15.6 | 440 | 12.3 | 454 | 14.0 | 452 | 13.8 | 3.1% |
| | ACR | 29 | 0.6 | 29 | 0.8 | 30 | 0.8 | 29 | 0.7 | 29 | 0.7 | 2.5% |
| 3 | ALB | 251 | 8.4 | 248 | 8.6 | 251 | 8.0 | 237 | 10.5 | 247 | 8.9 | 3.6% |
| | CRE | 82 | 2.3 | 81 | 2.2 | 79 | 3.0 | 79 | 3.2 | 80 | 2.7 | 3.4% |
| | ACR | 308 | 6.1 | 308 | 6.6 | 316 | 7.9 | 302 | 9.1 | 308 | 7.5 | 2.4% |
Between Run/Operator
| Urine Samples | Site 1 | | Site 2 | | Site 3 | | Site 4 | | Overall | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | Mean | SD | Mean | SD | Mean | SD | Mean | SD | Mean | SD | % CV |
| 1 | ALB | 125 | 2.8 | 125 | 3.9 | 124 | 2.1 | 120 | 3.7 | 123 | 3.2 | 2.6% |
| | CRE | 62 | 1.3 | 61 | 1.8 | 59 | 0.8 | 59 | 1.4 | 60 | 1.4 | 2.3% |
| | ACR | 202 | 1.4 | 203 | 0.0 | 210 | 2.6 | 202 | 3.8 | 204 | 2.4 | 1.2% |
| 2 | ALB | 134 | 0.9 | 131 | 0.0 | 131 | 0.0 | 130 | 0.0 | 131 | 0.5 | 0.3% |
| | CRE | 460 | 0.0 | 453 | 2.8 | 440 | 3.9 | 454 | 0.0 | 452 | 2.4 | 0.5% |
| | ACR | 29 | 0.2 | 29 | 0.0 | 30 | 0.0 | 29 | 0.3 | 29 | 0.2 | 0.6% |
| 3 | ALB | 251 | 6.0 | 248 | 3.0 | 251 | 3.2 | 237 | 0.0 | 247 | 3.7 | 1.5% |
| | CRE | 82 | 1.5 | 81 | 2.2 | 79 | 2.9 | 79 | 1.8 | 80 | 2.2 | 2.7% |
| | ACR | 308 | 0.0 | 308 | 5.9 | 316 | 9.7 | 302 | 0.0 | 308 | 5.7 | 1.8% |
Between Day/Lot
| Urine Samples | Site 1 | | Site 2 | | Site 3 | | Site 4 | | Overall | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | Mean | SD | Mean | SD | Mean | SD | Mean | SD | Mean | SD | % CV |
| 1 | ALB | 125 | 1.4 | 125 | 1.7 | 124 | 1.4 | 120 | 1.8 | 123 | 1.6 | 1.3% |
| | CRE | 62 | 0.7 | 61 | 1.0 | 59 | 0.0 | 59 | 0.0 | 60 | 0.6 | 1.0% |
| | ACR | 202 | 0.0 | 203 | 0.0 | 210 | 1.9 | 202 | 1.0 | 204 | 1.1 | 0.5% |
| 2 | ALB | 134 | 0.0 | 131 | 2.1 | 131 | 2.7 | 130 | 0.0 | 131 | 1.7 | 1.3% |
| | CRE | 460 | 1.8 | 454 | 3.9 | 440 | 0.9 | 454 | 0.0 | 452 | 2.2 | 0.5% |
| | ACR | 29 | 0.0 | 29 | 0.2 | 30 | 0.5 | 29 | 0.2 | 29 | 0.3 | 1.1% |
| 3 | ALB | 251 | 0.0 | 248 | 1.5 | 251 | 0.0 | 237 | 1.9 | 247 | 1.2 | 0.5% |
| | CRE | 82 | 0.0 | 81 | 0.0 | 79 | 0.0 | 79 | 0.7 | 80 | 0.4 | 0.5% |
| | ACR | 308 | 0.0 | 308 | 1.0 | 316 | 1.0 | 302 | 0.0 | 308 | 0.7 | 0.2% |
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Within Laboratory
| Urine Samples | Site 1 | | Site 2 | | Site 3 | | Site 4 | | Overall | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | Mean | SD | Mean | SD | Mean | SD | Mean | SD | Mean | SD | % CV |
| 1 | ALB | 125 | 5.6 | 125 | 5.7 | 124 | 5.5 | 120 | 5.8 | 123 | 5.6 | 4.6% |
| | CRE | 62 | 2.9 | 61 | 2.8 | 59 | 2.9 | 59 | 2.9 | 60 | 2.9 | 4.8% |
| | ACR | 202 | 4.5 | 203 | 5.5 | 210 | 7.0 | 202 | 6.7 | 204 | 6.0 | 2.9% |
| 2 | ALB | 134 | 5.0 | 131 | 6.3 | 131 | 5.4 | 130 | 5.0 | 131 | 5.4 | 4.1% |
| | CRE | 460 | 13.6 | 453 | 18.3 | 440 | 13.6 | 454 | 14.7 | 452 | 15.2 | 3.4% |
| | ACR | 29 | 0.7 | 29 | 0.9 | 30 | 1.1 | 29 | 0.7 | 29 | 0.9 | 3.0% |
| 3 | ALB | 251 | 11.2 | 248 | 9.2 | 251 | 9.9 | 237 | 11.2 | 247 | 10.4 | 4.2% |
| | CRE | 82 | 3.1 | 81 | 3.0 | 79 | 3.9 | 79 | 4.1 | 80 | 3.6 | 4.5% |
| | ACR | 308 | 7.0 | 308 | 8.4 | 316 | 14.1 | 302 | 8.7 | 308 | 9.9 | 3.2% |
Between-Site
| Control Samples | Cartridge Lot 1 | | Cartridge Lot 2 | | Cartridge Lot 3 | | Overall | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | Mean | SD | Mean | SD | Mean | SD | Mean | SD | % CV |
| L1 | ALB | 47 | 0.4 | 47 | 0.5 | 46 | 0.4 | 47 | 0.5 | 1.0% |
| | CRE | 85 | 0.0 | 85 | 1.4 | 85 | 0.4 | 85 | 0.8 | 1.0% |
| | ACR | 55 | 0.7 | 55 | 0.5 | 55 | 0.7 | 55 | 0.6 | 1.2% |
| L2 | ALB | 153 | 0.0 | 153 | 3.7 | 151 | 1.9 | 152 | 2.4 | 1.6% |
| | CRE | 216 | 1.9 | 216 | 2.40 | 215 | 1.6 | 216 | 2.0 | 0.9% |
| | ACR | 71 | 0.5 | 71 | 0.9 | 70 | 1.0 | 71 | 0.8 | 1.2% |
2. Linearity:
A study was performed to validate the Nova Allegro UACR Assay linearity and reportable ranges described below:
| | Range Evaluated | Levels | Slope | Intercept | r | Reportable Range |
| --- | --- | --- | --- | --- | --- | --- |
| Albumin | 0 – 362 mg/L | 9 | 0.994 | 2.52 | 0.997 | 5 – 300 mg/L |
| Creatinine | 0 – 507 mg/dL | 9 | 0.997 | 4.73 | 0.999 | 15 – 500 mg/dL |
If the albumin or creatinine value is outside the reportable range, no ACR test result will be reported.
Hook Effect Study
A study was performed to validate and determine at what concentration level the Nova Allegro UACR Assay exhibits a characteristic "Hook Effect" when measuring albumin. No "Hook effect" was observed with albumin up to 50,000 mg/L.
3. Analytical Specificity/Interference:
A study was performed to test for potentially interfering substances with the Nova Allegro
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UACR Assay according to Interference Testing in Clinical Chemistry; Approved Guideline - Third Edition: CLSI EP07-A3.
Ten (10) replicate measurements were made on both prepared specimens containing each potential interfering substance and control specimens containing no interfering substance. The mean albumin and creatinine concentration of the ten (10) replicates for both the test and control pools for each of the interfering substances, and percent difference between the mean test value and the mean control value were calculated. Acceptance criteria for interfering substance is ≤10%.
Albumin concentrations were targeted to approximately 20 mg/L and 220 mg/L and creatinine, targeted to approximately 56 mg/dL and 450 mg/dL with the interferents as described in the table below.
| Substances | Highest tested concentration without significant interference |
| --- | --- |
| Acetaminophen | 20 mg/dL |
| Acetaminophen – glucuronide | 1050 mg/dL |
| Acetone | 80 mg/dL |
| Albumin | 1000 mg/dL |
| Ammonium Chloride | 100 mg/dL |
| β-Hydroxybutyric Acid | 590 mg/dL |
| β-Microglobulin | 2 mg/dL |
| Blood | 50 Ery/μL |
| Calcium Chloride | 180 mg/dL |
| Citric Acid | 75 mg/dL |
| Creatine | 1000 mg/dL |
| Creatinine | 620 mg/dL |
| Digoxin | 0.03 mg/dL |
| Ethyl Acetoacetate | 84 mg/dL |
| Fructose | 100 mg/dL |
| Galactose | 80 mg/dL |
| Glucose | 4500 mg/dL |
| Glybenclamide | 1.48 mg/dL |
| Glyburide | 1.48 mg/dL |
| Glycine | 450 mg/dL |
| Hemoglobin | 10 mg/dL |
| Ibuprofen | 200 mg/dL |
| IgA | 25 mg/dL |
| IgG | 2000 mg/dL |
| Insulin | 500 μU/mL |
| Lactose | 10 mg/dL |
| Lithium Acetoacetate | 250 mg/dL |
| Metformin | 400 mg/dL |
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| Myoglobin | 2 mg/dL |
| --- | --- |
| Sodium Acetate | 2.25 mg/dL |
| Sodium Bicarbonate | 1500 mg/dL |
| Sodium Nitrate | 10 mg/dL |
| Sodium Nitrite | 10 mg/dL |
| Sodium Phosphate | 500 mg/dL |
| Theophylline | 100 mg/dL |
| Transferin | 200 mg/dL |
| Trichlormethiazide | 2 mg/dL |
| Urea | 3000 mg/dL |
| Uric acid | 150 mg/dL |
| Urobilinogen | 20 mg/dL |
Significant interference (>10%) was observed at the following concentration levels.
| Interfering Substances | Targeted Tested Concentration | Highest tested concentration that does not cause interference | |
| --- | --- | --- | --- |
| | | Albumin | Creatinine |
| Oxalic Acid | 70 mg/dL | 40 mg/dL | 70 mg/dL |
| Conjugated Bilirubin | 20 mg/dL | 4.2 mg/dL | 20 mg/dL |
| Riboflavin – Vitamin B2 | 10 mg/dL | 2.5 mg/dL | 10 mg/dL |
| Sodium chloride | 5500 mg/dL | 2000 mg/dL | 5500 mg/dL |
| Potassium chloride | 1500 mg/dL | 1200 mg/dL | 1500 mg/dL |
| Leukocytes | 2500/μL | 2500/μL | 1250/μL |
| Ascorbic acid | 300 mg/dL | 300 mg/dL | 100 mg/dL |
Effects of urine pH: Five (5) fresh urine specimens were pooled and divided into two sample pools. Both samples were then divided into 7 aliquots and the pH of the aliquots were adjusted to have pH values of 4.0, 4.3, 4.5, 5.0, 6.0, 7.0, 8.0, 9.0, and 10.0. The results demonstrated that changes in pH ranging from 4.3 to 9.0 do not interfere with the results of albumin and creatinine.
## Effects of urine specific gravity:
Fresh urine samples with low specific gravity (≤1.005) were pooled and divided into six (6) aliquots. Five (5) aliquots were adjusted to specific gravity of 1.01, 1.02, 1.03, 1.04, and 1.05 and spiked with a combination of albumin and creatinine. The results demonstrated that changes in specific gravity ranging from 1.003 to 1.048 do not interfere with the results of albumin and creatinine.
## 4. Assay Reportable Range:
Albumin: 5 – 300 mg/L
Creatinine: 15 – 500 mg/dL
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5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
Albumin calibration standards are traceable to BCR/CRM 470 IFCC reference materials and creatinine calibration standards are traceable to NIST SRM 914.
6. Detection Limit:
Studies for detection limit were conducted following CLSI EP 17-A2.
Three (3) Nova Allegro Analyzers and three (3) lots of Nova Allegro UACR Test Cartridges were used in the study. Sixty (60) replicate measurements were tested to determine the limit of blank (LOB) and the limit of detection (LOD) and thirty six (36) replicate measurements were tested to determine the limit of quantitation (LOQ). Nova Allegro Urine Calibrator base matrix was used for determining the LOB. Urine samples spiked with albumin and creatinine were used for determining the LOD and LOQ. The total error goal for LOQ were defined as ≤2 mg/L for albumin and ≤3 mg/dL for creatinine.
| Analyte | LOB | LOD | LOQ |
| --- | --- | --- | --- |
| Albumin | 1.9 mg/L | 2.1 mg/L | 3.5 mg/L |
| Creatinine | 1.4 mg/dL | 2.6 mg/dL | 4.4 mg/dL |
7. Assay Cut-Off:
Not applicable
8. Accuracy (Instrument):
See Section VII.B.1 Method Comparison with Predicate Device.
9. Carry over:
The Nova Allegro UACR Test Cartridges are fully self-contained test cartridges. The sponsor describes that no contact is made between the system instrumentation and the reagents or test sample.
B Comparison Studies:
1. Method Comparison with Predicate Device:
Point-of-Care (POC) Method Comparison studies on fresh urine specimens were conducted within four (4) different POC sites using methods described in CLSI "Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline – Third Edition", CLSI EP09c.
A total of eight (8) Nova Allegro Analyzers (2 per site) and three (3) lots of Allegro UACR Test Cartridges were used in the study. At each site, a minimum of 3 operators conducted the
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testing over 20 days using freshly collected urine specimens. A small percentage of test specimens were altered to cover the analytical measurement range of the Nova Allegro UACR Assay for albumin and creatinine.
Specimens run on the Nova Allegro Analyzers using the Nova Allegro UACR Assay were compared to the Siemens Dimension EXL 200 Integrated Chemistry System utilizing Dimension® Flex® reagent cartridge MALB, Dimension calibrator cartridge MALB CAL, Dimension Flex Reagent Cartridge CRE2, and Dimension CHEM 1 CAL as the comparator method. Least Squares Linear Regression Analyses were performed with the following results for all 4 sites combined:
| Analyte | Total No. of Samples | Sample Range | No. of Samples within AMR | Slope | Intercept |
| --- | --- | --- | --- | --- | --- |
| Albumin (mg/L) | 659 | 5 – 300 | 535 | 0.98 | 0.86 |
| Creatinine (mg/dL) | 659 | 16 – 498 | 653 | 0.95 | 3.78 |
| UACR (mg/g) | 659 | 1 – 1592 | 531 | 0.99 | 1.10 |
2. Matrix Comparison:
Not Applicable
C Clinical Studies:
1. Clinical Sensitivity:
Not applicable
2. Clinical Specificity:
Not applicable
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:
| | Albumin (Timed Collection) | Creatinine | UACR (Spot Collection) |
| --- | --- | --- | --- |
| Normal | < 20 μg/min | 34 – 147 mg/dL | < 30 mg/g |
| Microalbuminuria | 20 – 200 μg/min | | 30 – 300 mg/g |
| Clinical Albuminuria | >200 μg/min | | > 300 mg/g |
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F Other Supportive Instrument Performance Characteristics Data:
Electrical safety and electromagnetic compatibility (EMC) testing had been performed and the system was found to be compliant.
Software and cybersecurity documentation 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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