(683 days)
No
The document describes a glucose analyzer utilizing a glucose oxidase sensor and membrane. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies. The comparison is made to a predicate device from 1989, which is unlikely to incorporate AI/ML.
No
The device is an in vitro diagnostic device used for measuring glucose levels, which aids in diagnosis and treatment, but does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is indicated for "in vitro diagnostic use" and that "The measurement of Glucose is used in the diagnosis and treatment of carbohydrate metabolism disorders".
No
The device description clearly lists hardware components such as the "Nova Primary Glucose Analyzer," "Nova Primary Glucose Sensor," and "Nova Primary Glucose Membrane," indicating it is a hardware-based system with software likely embedded or accompanying it, not a standalone software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states the device is "indicated for in vitro diagnostic use." It also describes its use for the "quantitative determination of Glucose in lithium heparinized venous whole blood and plasma," which are samples taken in vitro (outside the body).
- Device Description: The description details how the device analyzes blood and plasma samples using a sensor and membrane, which is characteristic of an in vitro diagnostic process.
- Sample Types: The specified sample types (whole blood and plasma) are biological samples analyzed in vitro.
- Performance Studies: The performance studies described, such as Method Comparison, Precision/Reproducibility, and Linearity Testing, are standard evaluations for in vitro diagnostic devices to ensure their accuracy and reliability in analyzing biological samples.
- Predicate Device: The predicate device listed, the YSI 2300 Stat Glucose and L-Lactate Analyzer, is also an in vitro diagnostic device used for similar measurements.
All these points strongly indicate that the Nova Primary Glucose Analyzer System is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Nova Primary Glucose Analyzer System is indicated for in vitro diagnostic use by healthcare professionals in clinical laboratory setting for the quantitative determination of Glucose in lithium heparinized venous whole blood and plasma.
The measurement of Glucose is used in the diagnosis and treatment of carbohydrate metabolism distuding diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and pancreatic islet cell carcinoma.
Product codes
CGA
Device Description
The Nova Primary Glucose Analyzer System is a small, portable laboratory glucose analyzer that measures blood glucose levels in lithium heparinized whole blood or plasma utilizing a glucose oxidase based sensor and membrane/cap assembly.
The Nova Primary Glucose Analyzer accepts samples from syringes, blood collection tubes, microcentrifuge tubes, and sample cups. The sample size for analysis is 25 microliters (aspirated volume).
Nova Primary System Components:
The Nova Primary Glucose Analyzer System is comprised of the following components.
- Nova Primary Glucose Analyzer
- . Nova Primary Glucose Sensor
- . Nova Primary Glucose Membrane
- Nova Primary Calibrator Cartridge
- Optional Barcode Scanner
- . IFU/Labeling
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals in clinical laboratory setting
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
Not Found
Summary of Performance Studies
Testing was completed to show that the Nova Primary Glucose Analyzer demonstrates substantial equivalence to the YSI 2300 Stat Glucose and L-Lactate Analyzer. The performance testing included:
- Method Comparison Studies
- Precision/Reproducibility Studies
- Linearity Testing
- Specificity / Interference Testing
- Detection Limit
- Shelf Life Stability Testing .
The results of the performance testing confirmed that the Nova Primary Glucose Analyzer demonstrates substantial equivalence to the YSI 2300 Stat Glucose and L-Lactate Analyzer.
Key Metrics
Not Found
Predicate Device(s)
K891480 -YSI 2300 Stat Glucose and L-Lactate Analyzer
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo 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.
October 18, 2022
Nova Biomedical Corporation Robert Zinck Senior Manager Regulatory Affairs 200 Prospect Street Waltham, MA 02454
Re: K203549
Trade/Device Name: Nova Primary Glucose Analyzer System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: CGA Dated: July 29, 2022 Received: August 2, 2022
Dear Robert Zinck:
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 (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 located 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.
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
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 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 Caposino, Ph.D. Acting Deputy 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
2
Indications for Use
510(k) Number (if known) K203549
Device Name
Nova Primary Glucose Analyzer System
Indications for Use (Describe)
The Nova Primary Glucose Analyzer System is indicated for in vitro diagnostic use by healthcare professionals in clinical laboratory setting for the quantitative determination of Glucose in lithium heparinized venous whole blood and plasma.
The measurement of Glucose is used in the diagnosis and treatment of carbohydrate metabolism distuding diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and pancreatic islet cell carcinoma.
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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3
510(k) Summary K203549
| 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: | Robert Zinck, Senior Manager Regulatory Affairs |
| Date Prepared: | October 14, 2022 |
Proprietary Name: Nova Primary Glucose Analyzer System
Common or Usual Name: Blood Glucose Analyzer
Classification Name:
| Regulation section | Classification | Product
code |
|---------------------------------------|----------------|-----------------|
| 21 CFR § 864.1345 Glucose Test System | Class II | CGA |
Product Code:
CGA
Predicate Device:
K891480 -YSI 2300 Stat Glucose and L-Lactate Analyzer
Device Description:
The Nova Primary Glucose Analyzer System is a small, portable laboratory glucose analyzer that measures blood glucose levels in lithium heparinized whole blood or plasma utilizing a glucose oxidase based sensor and membrane/cap assembly.
The Nova Primary Glucose Analyzer accepts samples from syringes, blood collection tubes, microcentrifuge tubes, and sample cups. The sample size for analysis is 25 microliters (aspirated volume).
Nova Primary System Components:
The Nova Primary Glucose Analyzer System is comprised of the following components.
- Nova Primary Glucose Analyzer ●
- . Nova Primary Glucose Sensor
- . Nova Primary Glucose Membrane
- Nova Primary Calibrator Cartridge ●
- Optional Barcode Scanner .
- . IFU/Labeling
Sample Types:
The Nova Primary Glucose Analyzer System accepts lithium heparinized venous whole blood and plasma.
4
Intended Use:
Please see Indication for Use.
Indication for Use:
The Nova Primary Glucose Analyzer System is indicated for in vitro diagnostic use by healthcare professionals in clinical laboratory settings for the quantitative determination of Glucose in lithium heparinized venous whole blood and plasma.
The measurement of Glucose is used in the diagnosis and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypodycemia, and idiopathic hypodlycemia, and pancreatic islet cell carcinoma.
Summary of the Technological Characteristics:
The Nova Primary Glucose Analyzer was designed to be substantially equivalent in performance to the predicate device, incorporating modern technology updates in the analyzer platform.
The Nova Primary Glucose Analyzer utilizes a discrete, easily replaceable glucose sensor and membrane/cap assembly. Glucose measurement is conducted on diluted venous whole blood or plasma samples and is based on the enzymatic reaction between glucose and oxygen molecules in the presence of the glucose oxidase enzyme. All glucose measurement algorithms are intended to report plasma equivalent glucose results that are substantially equivalent to the predicate device plasma glucose result, and are traceable to isotope dilution mass spectrometry. For whole blood specimens, the Nova Primary Glucose Analyzer utilizes an impedance-based conductivity detector to automatically adjust glucose measurement and provide the plasma equivalent glucose value based on the conductivity of the sample.
Principle of Measurement:
Glucose measurement is based on the level of H2O2 produced during the enzymatic reaction between glucose and oxygen molecules in the presence of the dlucose enzyme. At a constant potential of 0.70 volts, electroactive HzO2 is oxidized at the surface of the platinum anode. The current generated by the flow of electrons at the surface of the platinum electrode is proportional to the glucose concentration of the sample.
Summary of Performance Testing:
Testing was completed to show that the Nova Primary Glucose Analyzer demonstrates substantial equivalence to the YSI 2300 Stat Glucose and L-Lactate Analyzer. The performance testing included:
- Method Comparison Studies ●
- Precision/Reproducibility Studies .
- Linearity Testing
- Specificity / Interference Testing ●
- Detection Limit .
- Shelf Life Stability Testing .
The results of the performance testing confirmed that the Nova Primary Glucose Analyzer demonstrates substantial equivalence to the YSI 2300 Stat Glucose and L-Lactate Analyzer.
Conclusion:
The results of software validation and performance verification testing confirmed that the Nova Primary Glucose Analyzer System demonstrates substantial equivalence to the YSI 2300 Stat Glucose and L-Lactate Analyzer (K891480 - predicate device).
5
| Table 1: Comparison of Predicate and Proposed Devices | |
|---|---|
| -- | ------------------------------------------------------- |
| Characteristic | Predicate: | Proposed: |
|---|---|---|
| Intended/Indications | ||
| for Use | The YSI 2300 STAT PLUS Glucose and | |
| Lactate Analyzer is a laboratory instrument | ||
| intended for use in clinical care and sports | ||
| medicine applications. It provides quick | ||
| measurements of glucose in whole blood, | ||
| plasma or serum; and of L-lactate in whole | ||
| blood, plasma, or cerebrospinal fluid (CSF). | ||
| In whole blood or plasma, glucose and L- | ||
| lactate can be measured simultaneously. | The Nova Primary Glucose Analyzer System | |
| is indicated for in vitro diagnostic use by | ||
| healthcare professionals in clinical laboratory | ||
| settings for the quantitative determination of | ||
| Glucose in lithium heparinized venous whole | ||
| blood and plasma. | ||
| The measurement of Glucose is used in the | ||
| diagnosis and treatment of carbohydrate | ||
| metabolism disturbances including diabetes | ||
| mellitus, neonatal hypoglycemia, and | ||
| idiopathic hypoglycemia, and pancreatic islet | ||
| cell carcinoma. | ||
| Intended Users | Trained laboratory personnel | Same |
| Measured Tests | Glucose and Lactate | Glucose |
| Glucose Enzyme | Glucose Oxidase | Same |
| Acceptable Sample | ||
| Types | Whole Blood, Plasma, Serum | Lithium Heparin Whole Blood or Plasma |
| Sample Size | ||
| Requirement | 25 microliters (aspirated volume) | Same |
| Physical Dimensions | 10.0 x 14.0 x 14.0 inches | 19.0 x 19.0 x 6.0 inches |
| Instrument Weight | 25 pounds | Less than 30 pounds including the calibrator |
| cartridge | ||
| Sample Tray | Available Option | Not available |
| Bar Code Scanner | Not available | Optional, wireless bar code scanner via |
| internal USB dongle | ||
| Keyboard | Not available | Optional, wireless keyboard via internal USB |
| dongle | ||
| Power Supply | 110-120 VAC, 220-240 VAC | |
| 50–60 Hz | ||
| 50 Watts nominal | 100-240 VAC | |
| 47-63 Hz | ||
| Less than 50 Watts | ||
| Automatic Whole | ||
| Blood Hematocrit | ||
| Correction | No - Hematocrit is independently measured | |
| on a whole blood specimen then manually | ||
| entered into YSI 2300 to calculate equivalent | ||
| plasma glucose value. | Yes - Contains an impedance-based | |
| Conductivity Detector. Whole blood samples | ||
| are automatically adjusted to provide plasma | ||
| equivalent glucose values based on the | ||
| conductivity of the sample. | ||
| User Interface | ||
| Display | Alpha Numeric Liquid Crystal Display with 20 | |
| membrane keypad | PCAP Color Touchscreen Display with icon | |
| based Graphical User Interface | ||
| Printer | Yes onboard 2 ¼" thermal printer | Yes, onboard 2" thermal printer |
| Communication | ||
| Protocol | RS-232 serial port | Not available |