K Number
K232075
Device Name
StatStrip Glucose Hospital Meter System
Date Cleared
2024-02-23

(226 days)

Product Code
Regulation Number
862.1345
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood, and neonatal heel stick specimens throughout all hospital and all professional healthcare settings, including patients receiving intensive medical intervention/therapy. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonatal heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diabetes mellitus but is indicated for use in determining dysglycemia. The StatStrip Glucose Hospital Meter System includes the following components: - StatStrip Glucose Hospital Meter - StatStrip Glucose Test Strips
Device Description
StatStrip Glucose Hospital Meter System: The StatStrip Glucose Hospital Meter System is a hand-held testing device that works in conjunction with the StatStrip Glucose Test Strips to measure glucose in a whole blood sample. Meter operation is selfprompting using an illuminated color touch-screen Graphical User Interface (GUI). StatStrip Glucose Test Strips: The test strips contain a reaction layer that contains a glucose-enzyme (greater than 1.0 IU) and ferricyanide as a mediator. The test strip is touched to a drop of blood to initiate the test process. The strip is designed such that when a drop of blood is touched to the strip, the blood is drawn into the reaction space via capillary action. A simple one-step provides a blood glucose result. Test strips will be sold in vials of 25 strips. StatStrip Glucose Control Solutions: The control solutions are aqueous assayed solutions containing buffered D-Glucose, viscosity-adjusting agent, preservatives and other non-reactive ingredients (dye). They contain no products of human origin. There are three levels of controls, (Level 1, Level 2 and Level 3). These solutions will be offered for sale separately from the meter. StatStrip Glucose Linearity Solutions: There are 5 levels of Linearity solutions containing buffered D-Glucose, viscosity-adjusting agent, preservatives and other non-reactive ingredients (dve). They contain no products of human origin. These solutions are offered separately from the system for users to verify the performance of the system. Charging (Docking) Station: The meter charging station is a stationary accessory used to recharge the meter. The charging station has one slot for the meter to be placed and charged wirelessly. The charging station should be located central to the patient care area being served by the meter (e.g., a nursing station). The data charging station must remain plugged in to a wall outlet for power. The system still allows the charging station to be used to transfer data from the meter to a central workstation and allow meter setup information to be downloaded from the central workstation to the meter.
More Information

Not Found

No
The description focuses on electrochemical measurement of glucose and standard statistical analysis of performance, with no mention of AI or ML algorithms.

No
Explanation: This device is for in vitro diagnostic use, specifically for measuring glucose levels. It provides diagnostic information and does not directly provide therapy or therapeutic benefit to a patient.

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose".

No

The device description clearly outlines hardware components such as the "StatStrip Glucose Hospital Meter," "StatStrip Glucose Test Strips," and a "Charging (Docking) Station." While there is likely software involved in the meter's operation and data transfer, the system is fundamentally a hardware-based medical 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 system is intended for "in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood, and neonatal heel stick specimens". The term "in vitro diagnostic" is clearly used.
  • Device Description: The device measures glucose in a whole blood sample, which is a biological specimen taken from the body. The test strips contain reagents that react with the glucose in the blood sample outside of the body (in vitro).
  • Performance Studies: The performance studies involve testing biological samples (venous whole blood) and comparing the results to a reference analyzer, which is typical for validating an IVD.

The definition of an In Vitro Diagnostic (IVD) is a medical device that is used to perform tests on samples such as blood, urine, or tissues, to detect diseases, conditions, or infections. This device fits that definition perfectly by measuring glucose in blood samples to determine dysglycemia.

N/A

Intended Use / Indications for Use

The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood, and neonatal heel stick specimens throughout all hospital and all professional healthcare settings, including patients receiving intensive medical intervention/therapy.

The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick.

It is not intended for use with neonate cord blood specimens.

It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia.

Product codes

PZI

Device Description

The StatStrip Glucose Hospital Meter System is a hand-held testing device that works in conjunction with the StatStrip Glucose Test Strips to measure glucose in a whole blood sample. Meter operation is self-prompting using an illuminated color touch-screen Graphical User Interface (GUI).

StatStrip Glucose Test Strips:
The test strips contain a reaction layer that contains a glucose-enzyme (greater than 1.0 IU) and ferricyanide as a mediator. The test strip is touched to a drop of blood to initiate the test process. The strip is designed such that when a drop of blood is touched to the strip, the blood is drawn into the reaction space via capillary action. A simple one-step provides a blood glucose result. Test strips will be sold in vials of 25 strips.

StatStrip Glucose Control Solutions:
The control solutions are aqueous assayed solutions containing buffered D-Glucose, viscosity-adjusting agent, preservatives and other non-reactive ingredients (dye). They contain no products of human origin. There are three levels of controls, (Level 1, Level 2 and Level 3). These solutions will be offered for sale separately from the meter.

StatStrip Glucose Linearity Solutions:
There are 5 levels of Linearity solutions containing buffered D-Glucose, viscosity-adjusting agent, preservatives and other non-reactive ingredients (dve). They contain no products of human origin. These solutions are offered separately from the system for users to verify the performance of the system.

Charging (Docking) Station:
The meter charging station is a stationary accessory used to recharge the meter. The charging station has one slot for the meter to be placed and charged wirelessly. The charging station should be located central to the patient care area being served by the meter (e.g., a nursing station). The data charging station must remain plugged in to a wall outlet for power.

The system still allows the charging station to be used to transfer data from the meter to a central workstation and allow meter setup information to be downloaded from the central workstation to the meter.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood, and neonatal heel stick specimens

Indicated Patient Age Range

Not Found

Intended User / Care Setting

point-of-care, throughout all hospital and all professional healthcare settings, including patients receiving intensive medical intervention/therapy.

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

ACCURACY
Sample Size: 100 venous whole blood samples from consented donors (deidentified).
Source: Consented donors.
Test Method: Samples tested on three (3) StatStrip Glucose Hospital Meters (proposed device) and three (3) predicate devices, using three (3) lots of glucose test strips. Results compared with a reference analyzer.
Annotation Protocol: Bias or Bias% calculated against reference value. Results compared to FDA Guidance for POC Device Acceptance Criteria (Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use, Guidance for Industry and Food and Drug Administration Staff, September 29, 2020).

METHOD COMPARISON AND PRECISION
Sample Size: Seven (7) levels of deidentified venous whole blood samples from consented donors and five (5) levels of linearity solutions.
Source: Consented donors.
Test Method: Samples tested on five (5) StatStrip Glucose Hospital Meters (proposed device) and five (5) predicate devices, using three (3) lots of glucose test strips. Results compared to whole blood glucose measured on a reference analyzer.
Annotation Protocol: Mean, SD or CV% calculated for each linearity level and meter (n=60). Bias or Bias% (between calculated Means for each meter type) calculated for each venous whole blood level. Linear regression curves plotted for venous whole blood, comparing the StatStrip Glucose Hospital Meter System and the predicate device.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

ACCURACY
Study Type: Performance equivalency study.
Sample Size: 100 venous whole blood samples.
Key Results:
Next Generation StatStrip Glucose Hospital Meter (Proposed Device) Glucose concentrations

§ 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.

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February 23, 2024

Nova Biomedical Corporation Abhinav Kulkarni Regulatory Affairs Specialist-II 200 Prospect St. Waltham, Massachusetts 02454

Re: K232075

Trade/Device Name: StatStrip Glucose Hospital Meter System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: PZI Dated: October 26, 2023 Received: October 26, 2023

Dear Abhinav Kulkarni:

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).

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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 OS 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 (OS) 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.

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 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. 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

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Indications for Use

510(k) Number (if known) K232075

Device Name StatStrip Glucose Hospital Meter System

Indications for Use (Describe)

The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood, and neonatal heel stick specimens throughout all hospital and all professional healthcare settings, including patients receiving intensive medical intervention/therapy.

The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonatal heel stick.

It is not intended for use with neonate cord blood specimens.

It is not intended for the screening or diabetes mellitus but is indicated for use in determining dysglycemia.

The StatStrip Glucose Hospital Meter System includes the following components:

  • StatStrip Glucose Hospital Meter
  • StatStrip Glucose Test Strips
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) Number:K232075
510(K) Owner:Nova Biomedical Corporation
Registration Number:1219029
Address:200 Prospect St.
Waltham, MA 02454 USA

Contact Person: Abhinav Kulkarni Regulatory Affairs Specialist - II 781-894-0080 x 1672 (Office) akulkarni@novabio.com

Secondary Contact Person: Bobby Zinck Senior Manager, Requlatory Affairs 781-894-0800 x 1705 (Office) bzinck@novabio.com

Date Prepared October 26, 2023

Proprietary Name StatStrip Glucose Hospital Meter System

Common or Usual Name

Blood Glucose Meter

Classification Name:

Classification NameRegulation #ClassProduct CodePanel
Prescription Use Blood Glucose Meter for
Near-Patient Testing862.1345IIPZIClinical Chemistry

Predicate Device

The predicate device for this submission is the StatStrip Glucose Hospital Meter System (K181043).

Purpose for Submission:

The StatStrip Glucose Hospital Meter System previously cleared under K060345, K063821, K132121, K150281, and K181043 is being modified to a next-generation meter platform to incorporate a new ergonomic design, and a new Operating System (OS).

Device Description:

StatStrip Glucose Hospital Meter System:

The StatStrip Glucose Hospital Meter System is a hand-held testing device that works in conjunction with the StatStrip Glucose Test Strips to measure glucose in a whole blood sample. Meter operation is selfprompting using an illuminated color touch-screen Graphical User Interface (GUI).

5

StatStrip Glucose Test Strips:

The test strips contain a reaction layer that contains a glucose-enzyme (greater than 1.0 IU) and ferricyanide as a mediator. The test strip is touched to a drop of blood to initiate the test process. The strip is designed such that when a drop of blood is touched to the strip, the blood is drawn into the reaction space via capillary action. A simple one-step provides a blood glucose result. Test strips will be sold in vials of 25 strips.

StatStrip Glucose Control Solutions:

The control solutions are aqueous assayed solutions containing buffered D-Glucose, viscosity-adjusting agent, preservatives and other non-reactive ingredients (dye). They contain no products of human origin. There are three levels of controls, (Level 1, Level 2 and Level 3). These solutions will be offered for sale separately from the meter.

StatStrip Glucose Linearity Solutions:

There are 5 levels of Linearity solutions containing buffered D-Glucose, viscosity-adjusting agent, preservatives and other non-reactive ingredients (dve). They contain no products of human origin. These solutions are offered separately from the system for users to verify the performance of the system.

Charging (Docking) Station:

The meter charging station is a stationary accessory used to recharge the meter. The charging station has one slot for the meter to be placed and charged wirelessly. The charging station should be located central to the patient care area being served by the meter (e.g., a nursing station). The data charging station must remain plugged in to a wall outlet for power.

The system still allows the charging station to be used to transfer data from the meter to a central workstation and allow meter setup information to be downloaded from the central workstation to the meter.

Intended Use:

The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiplepatient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood, and neonate heel stick specimens throughout all hospital and all professional healthcare settings, including patients receiving intensive medical intervention/therapy.

The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick.

It is not intended for use with neonate cord blood specimens.

It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia.

The StatStrip Glucose Hospital Meter System includes the following components:

  • StatStrip Glucose Hospital Meter
  • StatStrip Glucose Test Strips

Summary of Performance Testing:

The following testing was completed to demonstrate that the StatStrip Glucose Hospital Meter System is substantially equivalent to the predicate device.

ACCURACY

This study validated the performance equivalency between the StatStrip Glucose Hospital Meter System and the predicate device by measuring glucose on deidentified venous whole blood samples from consented donors.

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Three (3) StatStrip Glucose Hospital Meters and three (3) predicate devices were tested side-by-side using three (3) lots of glucose test strips. A total of hundred (100) venous whole blood samples with glucose concentrations ranging from 20-600 mg/dL were tested on all meters, and the results were compared with a reference analyzer.

The Bias or Bias% for each specimen was calculated against the reference value, and the results were also compared to the FDA Guidance for POC Device Acceptance Criteria (Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use, Guidance for Industry and Food and Drug Administration Staff, September 29, 2020).

Next Generation StatStrip Glucose Hospital Meter (Proposed Device) Glucose concentrations 1.0 IU) | Same as Predicate |

| Quality Controls | Liquid, 3 levels | Same as Predicate |
| Linearity | Liquid, 5 levels | Same as Predicate |
| Docking Station | Yes | Same as Predicate |
| Wireless Charging | No | Yes |
| Battery | Yes, 3.7V Li Polymer Battery (rechargeable)
1250 mAh | Yes, 3.6V Li Polymer Battery (rechargeable)
2200 mAh |
| Barcode Scanner | Yes | Same as Predicate |
| Wi-Fi Connectivity | Yes (802.11 for wireless communication) | Same as Predicate |
| Software Operating
System (OS) | Windows CE | Linux |
| Dimensions | 146 mm (5.8 in) x 79 mm (3.1 in)
x 30 mm (1.18 in) | 158 mm (6.23 in) x 77 mm (3.04 in)
x 28 mm (1.11 in) |
| Weight | 220 grams (0.49 lb) | 215 grams (0.47 Ib) |
| Temperature range | 59°F - 104°F (15°C - 40°C) | Same as Predicate |
| Altitude | Up to 15,000 feet | Same as Predicate |
| Relative Humidity | Up to 90% (non-condensing) | Same as Predicate |

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*The Hematocrit Range for the StatStrip Glucose Hospital Meter System was established as 20-70% in K132121 and K181043 with the FDA.

Conclusion

The performance testing study data results confirmed that the StatStrip Glucose Hospital Meter System (K232075) is safe and effective for its intended purpose. The StatStrip Glucose Hospital Meter System is substantially equivalent to the predicate StatStrip Glucose Hospital Meter System (K181043).