(931 days)
Not Found
No
The summary mentions "image processing" but does not provide any indication that AI or ML is used for this processing or any other function of the device. There is no mention of AI, ML, deep learning, neural networks, or related terms. The performance studies described are standard clinical validation methods and do not suggest the use of AI/ML.
No.
The device is intended for in vitro diagnostic use to measure glycated Hemoglobin A1c for the monitoring of long-term blood glucose/metabolic control in individuals with diabetes mellitus. It provides diagnostic information but does not directly treat or prevent a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Nova Allegro HbA1c Assay is "intended for in vitro diagnostic use." The "Device Description" also details the analyzer and assay cartridge, both components of a system designed to determine the quantitative level of glycated Hemoglobin A1c, which is a diagnostic measurement for monitoring diabetes.
No
The device description clearly outlines hardware components like the analyzer, analytical bays, touchscreen, barcode scanner, printer, and test cartridges. While software is involved in processing, it is integral to a physical 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 HbA1c Assay is "intended for in vitro diagnostic use". It also describes the purpose of the assay as the "quantitative determination of the glycated Hemoglobin A1c) in capillary whole blood obtained from the fingertip" for "monitoring of long-term blood glucose/metabolic control in individuals with diabetes mellitus." This clearly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, prevention, or treatment of a disease or condition.
- Device Description: The description details a system (Analyzer and Assay) designed to perform a test on a biological sample (capillary whole blood).
- Care Setting: The intended use in "clinical laboratory and near-patient testing (point-of-care) settings" further supports its use in a diagnostic context.
N/A
Intended Use / Indications for Use
The Nova Allegro HbA1c Assay is intended for in vitro diagnostic use on the Nova Allegro Analyzer for the quantitative determination of the glycated Hemoglobin A1c) in capillary whole blood obtained from the fingerty. The results from this assay are intended to be used for the monitoring of long-term blood glucose/metabolic control in individuals with diabetes mellitus.
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)
LCP, JQT
Device Description
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, and are easily performed by non-technical personnel. 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 Allegro HbA1c Assay is a completely automated assay for the HbA1c in human whole blood and the calculation of estimated average glucose (eAG). Nova Allegro HbA1c Test Cartridges are the key element a user interacts with to obtain the HbA1c concentration in a Capillary finger-stick whole blood sample. The main components of the Test Cartridge are the Capillary that is used to obtain the Capillary finger-stick whole blood specimen and present it to the Test Cartridge and the reaction chamber. The Test Cartridge has a barcode label with lot specific information.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Capillary whole blood obtained from the fingertip
Indicated Patient Age Range
Not Found. Indicated for "individuals with diabetes mellitus".
Intended User / Care Setting
Clinical laboratory and near-patient testing (point-of-care) settings. Prescription Use. Waived users.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Bench testing and point-of-care clinical performance studies were completed in physician's offices to demonstrate that the Nova Allegro HbA1c 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: Eleven (11) linearity specimens were tested randomly on the Nova Allegro Analyzer and on a reference method. The data met acceptance criteria across the reportable range of 4.0-14.0 % HbA1c.
Interference Testing: Ten (10) replicate HbA1c tests were performed on hemolysate specimens containing potential interfering substances and control specimens. All potential interfering substances tested met the acceptance criteria and were demonstrated not to have a clinical interference on HbA1c test results. No significant interference ( 5.4%. No significant interference for samples containing Hemoglobin C (≤ 38.2%), Hemoglobin D (≤41.1%), Hemoglobin E (≤27.9%), Hemoglobin S (≤ 38.6%), and Hemoglobin A2 (≤ 6.5%).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Linearity: 4.0-14.0 % HbA1c reportable range.
- Interference Testing: All tested substances showed 5.4%. No significant interference for samples containing Hemoglobin C (≤ 38.2%), Hemoglobin D (≤41.1%), Hemoglobin E (≤27.9%), Hemoglobin S (≤ 38.6%), and Hemoglobin A2 (≤ 6.5%).
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.
K171650 - Alere Afinion HbA1c Assay on the Afinion 2 Analyzer
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
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 22, 2024
Nova Biomedical Corporation Cesidio Tempesta Regulatory Affairs Manager 200 Prospect St. Waltham, Massachusetts 02454
Re: K221326
Trade/Device Name: Nova Allegro HbA1c Assay, Nova Allegro Analyzer Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated Hemoglobin Assay Regulatory Class: Class II Product Code: LCP, JQT Dated: April 25, 2024 Received: April 26, 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.
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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).
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 Rule"). 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.
For comprehensive regulatory information about medical devices and radiation-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-regulatory
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assistance/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
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Indications for Use
510(k) Number (if known) K221326
Device Name
Nova Allegro HbA1c Assay, Nova Allegro Analyzer
Indications for Use (Describe)
The Nova Allegro HbA1c Assay is intended for in vitro diagnostic use on the Nova Allegro Analyzer for the quantitative determination of the glycated Hemoglobin A1c) in capillary whole blood obtained from the fingerty. The results from this assay are intended to be used for the monitoring of long-term blood glucose/metabolic control in individuals with diabetes mellitus.
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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510(k) Summary
510(K): K221326/CW220003
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
Contact Person: | Cesidio Tempesta | ||||
---|---|---|---|---|---|
Date Prepared: | November 22, 2024 |
Proprietary Name:
Nova Allegro Analyzer Nova Allegro HbA1c Assay
Common or Usual Name: Analyzer HbA1c Test
Classification Name
Classification Name | Regulation # | Class | Product Code |
---|---|---|---|
Glycosylated Hemoglobin Assay | 864.7470 | II | LCP |
Analyzer | 862.2400 | I | JQT |
Predicate Device:
K171650 - Alere Afinion HbA1c Assay on the Afinion 2 Analyzer
Device Description:
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, and are easily performed by non-technical personnel. 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
Nova Allegro HbA1c Assay
The Allegro HbA1c Assay is a completely automated assay for the HbA1c in human whole blood and the calculation of estimated average glucose (eAG). Nova Allegro HbA1c Test Cartridges are the key element a user interacts with to obtain the HbA1c concentration in a Capillary finger-stick whole blood sample. The main components of the Test Cartridge are the Capillary that is used to obtain the Capillary finger-stick whole blood specimen and present it to the Test Cartridge and the reaction chamber. The Test Cartridge has a barcode label with lot specific information.
Sample Types:
Capillary whole blood (from finger stick)
Intended Use:
The Nova Allegro HbA1c Assay is intended for in vitro diagnostic use on the Nova Allegro Analyzer for the quantitative determination of the glycated Hemoglobin A1c) in capillary whole blood obtained from the fingertip. The results from this assay are intended to be used for the monitoring of longterm blood glucose/metabolic control in individuals with diabetes mellitus.
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:
A whole blood sample containing Hemoglobin A1c and Total Hemoglobin are nonspecifically absorbed to latex particles. The anti-human mouse HbA1c antibody reacts with this forming a complex. Agglutination occurs when polyclonal antibody specifically reacts with the mouse antibody bound to the Hemoglobin A1c on the surface of the latex particles. The amount of agglutination is measured as absorbance. The HbA1c value is obtained from a stored calibration curve and displayed on the Nova Allegro Analyzer.
Summary of Performance Testing:
Bench testing and point-of-care clinical performance studies were completed in physician's offices to demonstrate that the Nova Allegro HbA1c 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
Testing was performed to validate the Nova Allegro HbA1c Assay (Test Method) linearity when compared to a reference method. Eleven (11) linearity specimens were tested randomly on the Nova Allegro Analyzer. The same eleven linearity specimens were then analyzed on the reference method.
The resulting linearity data met the acceptance criteria when compared to the reference method across the reportable range of 4.0-14.0 % HbA1c.
Interference Testing
Testing was performed to test for specific interfering substances with the Allegro HbA1c Assay.
Ten (10) replicate HbA1c tests were performed on prepared hemolysate specimens containing potential interfering substances as well as control specimens without the interfering substance.
The test substance was considered to exhibit interference if the absolute difference between the mean test value and the mean control value was greater than 10%.
Based upon the results, all potential interfering substances tested met the acceptance criteria and were demonstrated not to have a clinical interference on HbA1c test results. No significant interference ( 5.4%. The results from the Nova Allegro HbA1c Assay show that there is no significant interference for samples containing Hemoglobin C (≤ 38.2%), Hemoglobin D (≤41.1%), Hemoglobin E (≤27.9%), Hemoglobin S (≤ 38.6%), and Hemoglobin A2 (≤ 6.5%).
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Table 3: Comparison of Predicate and Proposed Devices | ||||
---|---|---|---|---|
Characteristic | Predicate: | Proposed: |
---|---|---|
Analyzer | K171650 - Alere Afinion™ 2 Analyzer | K221326 - Nova Allegro Nova Allegro |
Analyzer | ||
Intended Use | Afinion 2 analyzer is a compact multi-assay | |
analyzer for point-of-care testing, designed to | ||
analyze the Alere AfinionTM test cartridges. Afinion | ||
2 system, consisting of Afinion 2 analyzer and | ||
Alere Afinion test cartridges is for in vitro | ||
diagnostic use only. | 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. | ||
Analyzer | ||
Function | Assay cartridge processing including pumping, | |
heating, image processing | Same | |
Cartridge | ||
Interface | Physical processing of cartridge (locking, docking, | |
splitting, foil penetration, merging) | Physical processing of cartridge (locking, | |
docking, foil penetration, mixing assay) | ||
User Interface | User display and operating instructions in labeling | Same |
Peripheral units | A barcode reader and printer can be connected | Barcode reader and printer integrated into |
analyzer | ||
Components | Components in metal and injection molded | |
plastics | Same | |
Dimensions | 200 mm W x 186 mm H x 328 mm D 3.4 kg | 203 mm W x 356 mm H x 381 mm D 9.1 kg |
Connectivity | Ethernet plug incorporated into the analyzer and | |
connectivity software incorporated in the software. | Same | |
HbA1c Assay | K171650 - Alere Afinion HbA1c On | |
Afinion 2 Analyzer | K221326 - Nova Allegro HbA1c Assay on | |
Nova Allegro Analyzer | ||
Intended Use | Alere AfinionTM HbA1c is an in-vitro diagnostic | |
test for quantitative determination of glycated | ||
hemoglobin (% hemoglobin A1c, % HbA1c) in | ||
human whole blood. The measurement of % | ||
HbA1c is recommended as a marker of long-term | ||
metabolic control in persons with diabetes mellitus | The Nova Allegro HbA1c Assay is intended for | |
in vitro diagnostic use on the Nova Allegro | ||
Analyzer for the quantitative determination of | ||
the glycated Hemoglobin (% hemoglobin A1c) | ||
in capillary whole blood obtained from the | ||
fingertip. The results from this assay are | ||
intended to be used for the monitoring of long- | ||
term blood glucose/metabolic control in | ||
individuals with diabetes mellitus. | ||
Measurement | ||
Range | 4.0-15.0 % | 4.0-14.0% |
Test Principle | Automated boronate affinity assay. | Latex enhanced turbidimetric immunoassay. |
Type of Test | Quantitative in-vitro diagnostic test | Same |
Intended Users | Prescription use. Waived users. | Same |
Blood Sampling | Standard phlebotomy techniques for obtaining | |
venous blood samples. Fingerstick by use of | ||
lancet. | For use only with capillary Fingerstick whole | |
blood | ||
Procedure for | ||
Filling of | ||
Sampling | ||
Device | Touch the surface or bring the tip of the capillary | |
just beneath the surface of the blood drop/sample. | ||
Do not wipe off the capillary after filling | Same | |
Sample Volume | 1.5 µL | Same |
Capillary | ||
Material | Plastic | Glass |
Cartridge | ||
Barcode | For analyzer identification of HbA1c test with | |
capillary sampling device | Same | |
Package Insert | ||
and | ||
Quick Guide | Illustrations of cartridge and sampling device with | |
plastic capillary. | Illustrations of cartridge and sampling device | |
with glass capillary |
10
Substantial Equivalence
The results obtained from the nonclinical and clinical evaluations confirmed the accuracy of the Nova Allegro Analyzer and Nova Allegro HbA1c Assay when used in the health care settings outlined in its intended use.
The Nova Allegro Analyzer and Nova Allegro HbA1c Assay displayed substantial equivalence to the legally marketed predicate device, Alere Afinion HbA1c Assay on the Afinion 2 Analyzer (K171650).