(881 days)
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No
The document describes a standard automated immunoassay system for measuring albumin and creatinine in urine. There is no mention of AI or ML in the device description, intended use, or performance studies. The studies described are standard analytical validation methods for in vitro diagnostic devices.
No
The device is an in vitro diagnostic (IVD) device used for quantitative determination of albumin, creatinine, and UACR in human urine, aiding in the early diagnosis of nephropathy. It does not directly treat or prevent a disease or condition, which is the definition of a therapeutic device.
Yes
The device is described as aiding in the "early diagnosis of nephropathy" and is intended for "in vitro diagnostic use."
No
The device description clearly outlines hardware components like the "Nova Allegro Analyzer" which includes analytical bays, a touchscreen, barcode scanner, printer, etc. It also mentions "Nova Allegro Test Cartridges" as a key element. This indicates a system with significant hardware components, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Nova Allegro UACR Assay is intended for the quantitative determination of albumin, creatinine, and the albumin/creatinine ratio (UACR) in human urine. It also states that the Nova Allegro Analyzer is intended for in vitro diagnostic use.
- Device Description: The description of the Nova Allegro UACR Assay mentions that the results are used to determine albumin and creatinine levels in a human urine sample.
- Performance Studies: The performance studies described involve testing with fresh urine specimens and comparing results to a Comparative Method (CM), which is a standard practice for validating IVD devices.
The core function of the device is to analyze a biological sample (human urine) outside of the body to provide diagnostic information (albumin, creatinine, and UACR levels) that aids in the early diagnosis of nephropathy. This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CGX, JIQ, JQT
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
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D), in vitro diagnostic use in clinical laboratory and near-patient testing (point-of-care) settings.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Bench testing and point-of-care clinical performance studies were completed to demonstrate that the Nova Allegro UACR Assay achieves its intended performance during normal conditions of use in its intended environment and in its intended use population.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
-
Linearity Testing: A study was performed to validate the Nova Allegro UACR Assay linearity for albumin and creatinine. One (1) Nova Allegro Analyzer, one (1) lot of Nova Allegro UACR Test Cartridges, and UACR control solutions (Level 1 & Level 2) were used. UACR control solutions and two (2) urine pools containing low and very high albumin and creatinine concentrations were analyzed on the Nova Allegro Analyzer and in duplicate on the Comparative Method (CM). The linearity data meets 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 Effect: 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. Based upon the testing using both pooled urine specimens and calibrator matrix, 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 Limit: A study was performed to assess the low-level test performance with the Nova Allegro UACR Assay, Limit of Blank (LOB), Limit of Detection (LOD), and Limit of Quantification (LOQ). Three (3) Nova Allegro Analyzers and three (3) lots of Nova Allegro UACR Test Cartridges were used. Sixty (60) replicate measurements were tested to determine LOB and thirty six (36) replicate measurements were tested to determine LOQ. 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.
-
Interference Testing: Testing was performed for specific interfering substances with the Allegro UACR Assay, and to assess the impact of urine pH. Six (6) Nova Allegro Analyzers and four (4) lots of Nova Allegro UACR Test Cartridges were used. Ten (10) replicate UACR tests were performed on prepared urine specimens containing potential interfering substances as well as control specimens without the interfering substance. A test substance was considered to interfere with the assay if the absolute difference between the mean test value and the mean control value was greater than 10%. Substances listed in Table 1 demonstrated no significant interference. Substances listed in Table 2 demonstrated clinical interference. Urines with pH between 4.3 – 10.0 exhibited no interference. Urines with a pH of 4.0 exhibited a clinical interference for samples with low levels of Albumin. Urine with specific gravity between 1.003 and 1.048 exhibited no clinical interference.
-
Method Comparison: 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 EP9-A3. A total of eight (8) Nova Allegro Analyzers (2 per site) and three (3) lots of Allegro UACR Test Cartridges were used. At each site, a minimum of 3 operators conducted the testing (minimum 120 comparative specimens on two (2) Allegro Analyzers at each site). Specimens were tested over at least a 20-day period. Nova Allegro results were compared to the Siemens Dimension EXL 200 Integrated Chemistry System.
- Urine Albumin: For Albumin, the slopes for individual sites ranged from 0.967 to 1.000, and intercepts ranged from 0.257 to 1.179. The overall slope was 0.983, intercept 0.858, and r-value 0.998.
- Urine Creatinine: For Creatinine, the slopes for individual sites ranged from 0.937 to 1.010, and intercepts ranged from -0.600 to 5.322. The overall slope was 0.949, intercept 3.775, and r-value 0.997.
- UACR: For UACR, the slopes for individual sites ranged from 0.9762 to 1.017, and intercepts ranged from 0.454 to 1.724. The overall slope was 0.995, intercept 1.101, and r-value 0.997.
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Precision: Total Imprecision of the Nova Allegro UACR Assay in the hands of operators was assessed using methods described in CLSI "Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guidelines – Second Edition," CLSI EP5-A3 as guidance. Eight (8) Nova Allegro Analyzers (2 per site) and three (3) lots of Allegro UACR Test Cartridges were used.
- Repeatability: Microalbumin %CV ranges from 3.6% to 4.0%. Creatinine %CV ranges from 3.1% to 4.0%. UACR %CV ranges from 2.4% to 2.5%.
- Between Run/Operator: Microalbumin %CV ranges from 0.3% to 2.6%. Creatinine %CV ranges from 0.5% to 2.7%. UACR %CV ranges from 0.6% to 1.2%.
- Between Lot/Day: Microalbumin %CV ranges from 0.5% to 1.3%. Creatinine %CV ranges from 0.5% to 1.0%. UACR %CV ranges from 0.2% to 1.1%.
- Within Lab: Microalbumin %CV ranges from 4.1% to 4.6%. Creatinine %CV ranges from 3.4% to 4.8%. UACR %CV ranges from 2.9% to 3.2%.
- Between Site: Microalbumin %CV ranges from 1.0% to 1.6%. Creatinine %CV ranges from 0.9% to 1.0%. UACR %CV is 1.2%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1225 Creatinine test system.
(a)
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.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
November 19, 2024
Nova Biomedical Corporation Cesidio Tempesta Regulatory Affairs Manager 200 Prospect St. Waltham, Massachusetts 02454
Re: K221813
Trade/Device Name: Nova Allegro UACR Assay, Nova Allegro Analyzer Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine Test System Regulatory Class: Class II Product Code: CGX, JIQ, JQT Dated: April 5, 2024 Received: April 8, 2024
Dear Cesidio Tempesta:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
3
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Paula V. Caposino -S
Paula Caposino, Ph.D. Deputy Division Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K221813
Device Name Nova Allegro UACR Assay Nova Allegro Analyzer
Indications for Use (Describe)
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-ofcare) settings for the quantitative determination of Nova Allegro Assays using Nova Allegro Test Cartridges.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510(k) Summary
510(K) K221813 510(K) Owner: Nova Biomedical Corporation Registration Number: 1219029 Address: 200 Prospect St. Waltham. MA 02454 Phone: 781-894-0800 Fax Number: 784-891-4806 Contact Person: Cesidio Tempesta Date Prepared: November 18, 2024
Proprietary Name:
Nova Allegro Analyzer Nova Allegro UACR Assay
Common or Usual Name:
Analvzer UACR Test
Classification Name
| Classification Name | Regulation # | Class | Product Code |
|---|---|---|---|
| Urinary protein or albumin (nonquantitative) test system | 862.1645 | I | JIQ |
| Creatinine Test System | 862.1225 | II | CGX |
| Analyzer | 862.2400 | I | JQT |
Predicate Device:
K072409 – Afinion ACR and ACR Control
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
5
Sample Types:
Urine with no preservative
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.
Principle of Measurement:
When a urine sample containing albumin is reacted with antibody specific for albumin, an antibody albumin complex is formed. The amount of complex is in direct proportion to the amount of albumin in the sample. The albumin is then quantified using a stored calibration curve.
The Benedict/Behre chemistry is the creatinine assay. 3.5-dinitrobenzoic acid at high pH reacts with creatinine to form a colored complex. 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.
Summary of Performance Testing:
Bench testing and point-of-care clinical performance studies were completed to demonstrate that the Nova Allegro UACR Assay achieves its intended performance during normal conditions of use in its intended environment and in its intended use population. Testing is summarized as follows:
Linearity Testing
A study was performed to validate the Nova Allegro UACR Assay linearity for albumin and creatinine.
One (1) Nova Allegro Analyzer, one (1) lot of Nova Allegro UACR Test Cartridges, and UACR control solutions (Level 1 & Level 2) were used in this study. UACR control solutions and two (2) urine pools containing low and very high albumin and creatinine concentrations were analyzed on the Nova Allegro Analyzer and in duplicate on the Comparative Method (CM) to assess linearity.
The linearity data meets 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 Effect
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. A Hook Effect is a phenomenon that gives falsely low results in the presence of excess amount of analyte. This type of interference is common with homogenous immunoassays. The result reported here is specific to the antibody used in the Nova Allegro UACR assay.
Based upon the testing using both pooled urine specimens and calibrator matrix, 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. Samples between 301 and 50.000 mg/L of albumin will report "UAlb >300 mg/L" on the Allegro analyzer.
Detection Limit
A study was performed to assess the low-level test performance with the Nova Allearo UACR Assay, Limit of Blank (LOB), Limit of Detection (LOD), and Limit of Quantification (LOQ) are terms to describe the smallest concentration of an analyte that can be reliably measured by an analytical procedure.
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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 LOB and thirty six (36) replicate measurements were tested to determine LOQ.
Limit of Blank (LOB), Limit of Detection (LOD), and Limit of Quantification (LOQ) were calculated from the results. 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.
Interference Testing
Testing was performed for specific interfering substances with the Allegro UACR Assay, and to assess the impact of urine pH. Six (6) Nova Allegro Analyzers and four (4) lots of Nova Allegro UACR Test Cartridges were used in the study.
Ten (10) replicate UACR tests were performed on prepared urine specimens containing potential interfering substances as well as control specimens without the interfering substance.
A test substance was considered to interfere with the assay if the absolute difference between the mean test value and the mean control value was greater than 10%.
For any substance found to interfere with the assay results, serial dilutions were performed on test specimens to determine the highest concentration of interfering compound that does not interfere with the measurement.
Table 1 contains the list of substances that were demonstrated to have no significant interference (greater than 10% effect) on the Albumin or Creatinine test results.
| Test Substance | Concentration | Test Substance | Concentration |
|---|---|---|---|
| Acetaminophen-glucuronide | 1050 mg/dL | Citric Acid | 75 mg/dL |
| Acetaminophen | 20 mg/dL | Fructose | 100 mg/dL |
| Ethyl Acetoacetate | 84 mg/dL | Lactose | 10 mg/dL |
| Metformin | 400 mg/dL | Sodium Bicarbonate | 1500 mg/dL |
| Glyburide | 1.48 mg/dL | Digoxin | 0.03 mg/dL |
| IgG | 2000 mg/dL | Sodium Phosphate | 500 mg/dL |
| Acetone | 80 mg/dL | Ammonium Chloride | 100 mg/dL |
| Myoglobin | 2 mg/dL | Sodium Nitrite | 10 mg/dL |
| β-2-Microglobulin | 2 mg/dL | Calcium Chloride | 180 mg/dL |
| Red Blood Cells | 50 cells/µL | Creatine | 1000 mg/dL |
| IgA | 25 mg/dL | Galactose | 80 mg/dL |
| Transferin | 200 mg/dL | Glycine | 450 mg/dL |
| Insulin | 500 uU/mL | Lithium Acetoacetate | 250 mg/dL |
| β-Hydroxbutyric Acid | 590 mg/dL | Sodium Acetate | 2.25 mg/dL |
| Ibuprofen | 200 mg/dL | Sodium Nitrate | 10 mg/dL |
| Glucose | 4500 mg/dL | Theophylline | 100 mg/dL |
| Hemoglobin | 10 mg/dL | Uric acid | 150 mg/dL |
| Urea | 3000 mg/dL | Trichlormethiazide | 2 mg/dL |
| Albumin | 1000 mg/dL | Glybenclamide | 1.5 mg/dL |
| Creatinine | 620 mg/dL | Urobilinogen | 20 mg/dL |
Table 1: Tested Substances That Demonstrated No Significant Interference
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Table 2 contains the list of substances that were demonstrated to have a clinical interference (greater than 10% effect) on the Albumin or Creatinine test results.
Table 2: Interfering Substances
| Interfering Substance | Highest tested concentration that does not
cause interference | |
|------------------------|------------------------------------------------------------------|------------|
| | ALB | CREAT |
| Oxalic Acid | 40 mg/dL | 70 mg/dL |
| Conjugated Bilirubin | 4.2 mg/dL | 20 mg/dL |
| Riboflavin -Vitamin B2 | 2.5 mg/dL | 10 mg/dL |
| Sodium Chloride | 2000 mg/dL | 5500 mg/dL |
| Potassium Chloride | 1200 mg/dL | 1500 mg/dL |
| Leukocytes | 2500/ul | 1250/ul |
| Ascorbic Acid | 300 mg/dL | 100 mg/dL |
Note: Urines with pH between 4.3 – 10.0 exhibited no interference. Urines with a pH of 4.0 exhibited a clinical interference for samples with low levels of Albumin.
Note: Urine with specific gravity between 1.003 and 1.048 exhibited no clinical interference.
Note: Albumin. Creatinine and UACR results may be affected in samples with high concentrations of bilirubin and/or Vitamin B2 where the samples may appear discolored. Do not use the Allegro UACR Assay if the urine sample is discolored and not yellow or clear.
Method Comparison
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 EP9-A3.
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 testing (minimum 120 comparative specimens on two (2) Allegro Analyzers at each site).
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 were tested over at least a 20-day period to ensure system day-to-day variability was considered. 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 (Traceable to IFCC International Reference Preparation for Plasma Proteins), Dimension Flex Reagent Cartridge CRE2, and Dimension CHEM 1 CAL (Traceable to NIST SRM 914 and verified with NIST SRM 967) as the CM method. The combined test results for the four (4) POC sites participating in the Method Comparison study are in the following tables:
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| Albumin | Regression Analysis | ||||||
|---|---|---|---|---|---|---|---|
| Site | Number of | ||||||
| samples within | Altered | Sample range Allegro | |||||
| (min-max) | Slope | Intercept | r | ||||
| measurement | |||||||
| range | samples | ||||||
| 1 | 149 | 10 | 5 | 292 | 1.000 | 0.257 | 0.998 |
| 2 | 164 | 11 | 5 | 295 | 0.988 | 0.762 | 0.998 |
| 3 | 113 | 10 | 5 | 300 | 0.967 | 0.692 | 0.998 |
| 4 | 109 | 10 | 5 | 295 | 0.984 | 1.179 | 0.998 |
| ALL | 535 | 41 | 5 | 300 | 0.983 | 0.858 | 0.998 |
Table 3: Results Summary, Urine Albumin, Nova Allegro vs. CM - Combined
Table 4: Results Summary, Urine Creatinine, Nova Allegro vs. CM - Combined
| Creatinine | Regression Analysis | ||||||
|---|---|---|---|---|---|---|---|
| Site | Number of | ||||||
| samples within | |||||||
| measurement | |||||||
| range | Altered | ||||||
| samples | Sample range Allegro | ||||||
| (min-max) mg/dL | Slope | Intercept | r | ||||
| 1 | 188 | 0 | 18 | 498 | 0.937 | 5.322 | 0.998 |
| 2 | 201 | 0 | 16 | 451 | 0.939 | 4.112 | 0.996 |
| 3 | 136 | 0 | 16 | 426 | 0.995 | -0.569 | 0.997 |
| 4 | 128 | 0 | 24 | 397 | 1.010 | -0.600 | 0.996 |
| ALL | 653 | 0 | 16 | 498 | 0.949 | 3.775 | 0.997 |
Table 5: Results Summary, UACR, Nova Allegro vs. CM – Combined
| UACR ratio | Regression Analysis | |||||
|---|---|---|---|---|---|---|
| Number of samples that returned exact result# | Altered samples | Sample range Allegro (min-max) | Slope | Intercept | r | |
| Site | 148* | 10 | 3 544 | 1.011 | 0.699 | 0.997 |
| 1 | 161 | 11 | 2 1161 | 1.017 | 0.454 | 0.998 |
| 2 | 113 | 10 | 1 1592 | 0.9762 | 1.724 | 0.997 |
| 3 | 109 | 10 | 3 776 | 1.009 | 1.651 | 0.998 |
| 4 | 531* | 41 | 1 1592 | 0.995 | 1.101 | 0.997 |
| ALL |
9
Precision
Total Imprecision of the Nova Allegro UACR Assay in the hands of operators was 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 eight (8) Nova Allegro Analyzers (2 per site) and three (3) lots of Allegro UACR Test Cartridges were used in the study.
Table 6: Repeatability
Microalbumin
| Urine
| Samples | Repeatability | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Site 1 | Site 2 | Site 3 | Site 4 | Overall | |||||||
| Mean | SD | Mean | SD | Mean | SD | Mean | SD | Mean | SD | % CV | |
| Urine 1 | 125 | 4.4 | 125 | 4.5 | 124 | 5.0 | 120 | 4.0 | 123 | 4.5 | 3.6% |
| Urine 2 | 134 | 5.1 | 131 | 5.9 | 131 | 4.8 | 130 | 5.1 | 131 | 5.3 | 4.0% |
| Urine 3 | 251 | 8.4 | 248 | 8.6 | 251 | 8.0 | 237 | 10.5 | 247 | 8.9 | 3.6% |
Creatinine
| Urine
| Samples | Repeatability | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Site 1 | Site 2 | Site 3 | Site 4 | Overall | |||||||
| Mean | SD | Mean | SD | Mean | SD | Mean | SD | Mean | SD | % CV | |
| Urine 1 | 62 | 2.2 | 61 | 2.4 | 59 | 2.9 | 59 | 2.2 | 60 | 2.4 | 4.0% |
| Urine 2 | 460 | 13.2 | 453 | 15.6 | 440 | 12.3 | 454 | 14.0 | 452 | 13.8 | 3.1% |
| Urine 3 | 82 | 2.3 | 81 | 2.2 | 79 | 3.0 | 79 | 3.2 | 80 | 2.7 | 3.4% |
UACR
| Urine
| Samples | Repeatability | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Site 1 | Site 2 | Site 3 | Site 4 | Overall | |||||||
| Mean | SD | Mean | SD | Mean | SD | Mean | SD | Mean | SD | % CV | |
| Urine 1 | 202 | 4.2 | 203 | 5.5 | 210 | 5.0 | 202 | 5.5 | 204 | 5.1 | 2.5% |
| Urine 2 | 29 | 0.6 | 29 | 0.8 | 30 | 0.8 | 29 | 0.7 | 29 | 0.7 | 2.5% |
| Urine 3 | 308 | 6.1 | 308 | 6.6 | 316 | 7.9 | 302 | 9.1 | 308 | 7.5 | 2.4% |
Table 7: Between Run/Operator
Microalbumin
| Urine
| Samples | Between Run/Operator | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Site 1 | Site 2 | Site 3 | Site 4 | Overall | |||||||
| Mean | SD | Mean | SD | Mean | SD | Mean | SD | Mean | SD | % CV | |
| Urine 1 | 125 | 2.8 | 125 | 3.9 | 124 | 2.1 | 120 | 3.7 | 123 | 3.2 | 2.6% |
| Urine 2 | 134 | 0.9 | 131 | 0.0 | 131 | 0.0 | 130 | 0.0 | 131 | 0.5 | 0.3% |
| Urine 3 | 251 | 6.0 | 248 | 3.0 | 251 | 3.2 | 237 | 0.0 | 247 | 3.7 | 1.5% |
Creatinine
| Urine
| Samples | Between Run/Operator | Overall | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Site 1 | Site 2 | Site 3 | Site 4 | ||||||||
| Mean | SD | Mean | SD | Mean | SD | Mean | SD | Mean | SD | % CV | |
| Urine 1 | 62 | 1.3 | 61 | 1.8 | 59 | 0.8 | 59 | 1.4 | 60 | 1.4 | 2.3% |
| Urine 2 | 460 | 0.0 | 453 | 2.8 | 440 | 3.9 | 454 | 0.0 | 452 | 2.4 | 0.5% |
| Urine 3 | 82 | 1.5 | 81 | 2.2 | 79 | 2.9 | 79 | 1.8 | 80 | 2.2 | 2.7% |
UACR
| Urine
| Samples | Between Run/Operator | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Site 1 | Site 2 | Site 3 | Site 4 | Overall | |||||||
| Mean | SD | Mean | SD | Mean | SD | Mean | SD | Mean | SD | % CV | |
| Urine 1 | 202 | 1.4 | 203 | 0.0 | 210 | 2.6 | 202 | 3.8 | 204 | 2.4 | 1.2% |
| Urine 2 | 29 | 0.2 | 29 | 0.0 | 30 | 0.0 | 29 | 0.3 | 29 | 0.2 | 0.6% |
| Urine 3 | 308 | 0.0 | 308 | 5.9 | 316 | 9.7 | 302 | 0.0 | 308 | 5.7 | 1.8% |
10
Table 8: Between Lot/Day
Microalbumin
| Urine
| Samples | Between Lot/Day | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Site 1 | Site 2 | Site 3 | Site 4 | Overall | |||||||
| Mean | SD | Mean | SD | Mean | SD | Mean | SD | Mean | SD | % CV | |
| Urine 1 | 125 | 1.4 | 125 | 1.7 | 124 | 1.4 | 120 | 1.8 | 123 | 1.6 | 1.3% |
| Urine 2 | 134 | 0.0 | 131 | 2.1 | 131 | 2.7 | 130 | 0.0 | 131 | 1.7 | 1.3% |
| Urine 3 | 251 | 0.0 | 248 | 1.5 | 251 | 0.0 | 237 | 1.9 | 247 | 1.2 | 0.5% |
Creatinine
| Urine
| Samples | Between Lot/Day | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Site 1 | Site 2 | Site 3 | Site 4 | Overall | |||||||
| Mean | SD | Mean | SD | Mean | SD | Mean | SD | Mean | SD | % CV | |
| Urine 1 | 62 | 0.7 | 61 | 1.0 | 59 | 0.0 | 59 | 0.0 | 60 | 0.6 | 1.0% |
| Urine 2 | 460 | 1.8 | 454 | 3.9 | 440 | 0.9 | 454 | 0.0 | 452 | 2.2 | 0.5% |
| Urine 3 | 82 | 0.0 | 81 | 0.0 | 79 | 0.0 | 79 | 0.7 | 80 | 0.4 | 0.5% |
UACR
| Urine
| Samples | Between Lot/Day | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Site 1 | Site 2 | Site 3 | Site 4 | Overall | |||||||
| Mean | SD | Mean | SD | Mean | SD | Mean | SD | Mean | SD | ||
| Urine 1 | 202 | 0.0 | 203 | 0.0 | 210 | 1.9 | 202 | 1.0 | 204 | 1.1 | 0.5% |
| Urine 2 | 29 | 0.0 | 29 | 0.2 | 30 | 0.5 | 29 | 0.2 | 29 | 0.3 | 1.1% |
| Urine 3 | 308 | 0.0 | 308 | 1.0 | 316 | 1.0 | 302 | 0.0 | 308 | 0.7 | 0.2% |
Table 9: Within Lab
Microalbumin
| Urine
| Samples | Within Laboratory | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Site 1 | Site 2 | Site 3 | Site 4 | Overall | |||||||
| Mean | SD | Mean | SD | Mean | SD | Mean | SD | Mean | SD | % CV | |
| Urine 1 | 125 | 5.6 | 125 | 5.7 | 124 | 5.5 | 120 | 5.8 | 123 | 5.6 | 4.6% |
| Urine 2 | 134 | 5.0 | 131 | 6.3 | 131 | 5.4 | 130 | 5.0 | 131 | 5.4 | 4.1% |
| Urine 3 | 251 | 11.2 | 248 | 9.2 | 251 | 9.9 | 237 | 11.2 | 247 | 10.4 | 4.2% |
Creatinine
| Urine
| Samples | Within Laboratory | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Site 1 | Site 2 | Site 3 | Site 4 | Overall | |||||||
| Mean | SD | Mean | SD | Mean | SD | Mean | SD | Mean | SD | % CV | |
| Urine 1 | 62 | 2.9 | 61 | 2.8 | 59 | 2.9 | 59 | 2.9 | 60 | 2.9 | 4.8% |
| Urine 2 | 460 | 13.6 | 453 | 18.3 | 440 | 13.6 | 454 | 14.7 | 452 | 15.2 | 3.4% |
| Urine 3 | 82 | 3.1 | 81 | 3.0 | 79 | 3.9 | 79 | 4.1 | 80 | 3.6 | 4.5% |
UACR
| Urine
| Samples | Within Laboratory | Overall | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Site 1 | Site 2 | Site 3 | Site 4 | Mean | SD | % CV | |||||
| Urine 1 | 202 | 4.5 | 203 | 5.5 | 210 | 7.0 | 202 | 6.7 | 204 | 6.0 | 2.9% |
| Urine 2 | 29 | 0.7 | 29 | 0.9 | 30 | 1.1 | 29 | 0.7 | 29 | 0.9 | 3.0% |
| Urine 3 | 308 | 7.0 | 308 | 8.4 | 316 | 14.1 | 302 | 8.7 | 308 | 9.9 | 3.2% |
11
Table 10: Between Site
| Microalbumin | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Between Site | |||||||||
| Control | |||||||||
| Levels | Lot 1 | Lot 2 | Lot 3 | Overall | |||||
| Mean | SD | Mean | SD | Mean | SD | Mean | SD | % CV | |
| Control 1 | 47 | 0.4 | 47 | 0.5 | 46 | 0.4 | 47 | 0.5 | 1.0% |
| Control 2 | 153 | 0.0 | 153 | 3.7 | 151 | 1.9 | 152 | 2.4 | 1.6% |
Creatinine
| Control
| Levels | Between Site | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Lot 1 | Lot 2 | Lot 3 | Overall | ||||||
| Mean | SD | Mean | SD | Mean | SD | Mean | SD | % CV | |
| Control 1 | 85 | 0.0 | 85 | 1.4 | 85 | 0.4 | 85 | 0.8 | 1.0% |
| Control 2 | 216 | 1.9 | 216 | 2.40 | 215 | 1.6 | 216 | 2.0 | 0.9% |
UACR
| Control
| Levels | Between Site | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Lot 1 | Lot 2 | Lot 3 | Overall | ||||||
| Mean | SD | Mean | SD | Mean | SD | Mean | SD | % CV | |
| Control 1 | 55 | 0.7 | 55 | 0.5 | 55 | 0.7 | 55 | 0.6 | 1.2% |
| Control 2 | 71 | 0.5 | 71 | 0.9 | 70 | 1.0 | 71 | 0.8 | 1.2% |
12
| Characteristic | Predicate: | Proposed: |
|---|---|---|
| UACR Assay | K072409 – Afinion ACR and ACR | |
| Control | K221813 Nova Allegro UACR Assay | |
| Intended Use | Afinion™ ACR is an in vitro diagnostic | |
| test for quantitative determination of | ||
| albumin, creatinine and | ||
| albumin/creatinine ratio (ACR) in human | ||
| urine. The measurement of urine | ||
| albumin, creatinine and | ||
| albumin/creatinine ratio aids in the early | ||
| diagnosis of nephropathy. | ||
| Afinion™ ACR Control is a assayed in | ||
| vitro diagnostic quality control material | ||
| used to confirm that the Afinion™ ACR | ||
| and the Afinion™ AS100 Analyzer | ||
| System is working properly and provides | ||
| reliable results. | 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. | ||
| Measurement Range - Albumin | 5.0- 200.0 mg/L | 5.0 - 300 mg/L |
| Measurement Range - | ||
| Creatinine | 16.4-339.9 mg/dL | 15.0 - 500 mg/dL |
| Measurement Range - ACR | 1.0-1250.0 mg/g | 1.0 - 2,000 mg/g |
| Test Principle – Albumin | Immunometric membrane flow-through | |
| principle | Immunoturbidimetric measurement | |
| Test Principle – Creatinine | enzymatic colorimetric | alkaline colorimetric |
| Type of Test | Point-of-Care quantitative in-vitro | |
| diagnostic test | Same | |
| Intended Users | Prescription Use. | Prescription Use |
| Sample Volume | 3.5 µL | 25 µL |
| Assay Time | 5 min 35 seconds | ≤7 Minutes |
| Calibration | Built In | Same |
Table 11: Comparison of Predicate and Proposed Devices
Substantial Equivalence
The results obtained from the nonclinical and clinical evaluations confirmed the accuracy of the Nova Allegro UACR Assay when used in the health care settings outlined in its intended use.
The Nova Allegro UACR Assay displayed substantial equivalence to the legally marketed predicate device, Afinion ACR and Afinion ACR Control (K072409).
The submitted information in this 510(k)-submission application is complete.
The data supports the 510(k) substantial equivalence approval decisions.