(90 days)
Not Found
No
The description focuses on the device's hardware, user interface, data storage, and wireless connectivity for data transfer. There is no mention of AI or ML being used for glucose measurement or any other function. The document explicitly states that the glucose measurement cycle is identical to the predicate device.
No.
The device is intended for in vitro diagnostic purposes to measure glucose levels, not for direct therapeutic treatment or intervention. While the information it provides can be used to guide therapeutic decisions, the device itself does not deliver therapy.
Yes.
The "Intended Use / Indications for Use" section explicitly states "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 neonate heel stick specimens." The phrase "in vitro diagnostic" directly indicates its diagnostic purpose. Additionally, it mentions it is "indicated for use in determining dysglycemia," which is a diagnostic function.
No
The device description clearly outlines hardware components such as the meter, charging station, battery, and test strips, which are integral to its function of measuring glucose. While it includes software for the user interface and data management, it is not solely software.
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 "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 neonate heel stick specimens." The phrase "in vitro diagnostic" is a direct indicator.
- Device Description: The description details components like test strips, control solutions, and linearity solutions, which are all typical reagents and consumables used in in vitro diagnostic testing. The process of applying a blood sample to a test strip and the meter measuring glucose is a classic example of an in vitro diagnostic method.
- Functionality: The device measures glucose in blood samples, which is a diagnostic test performed outside of the body (in vitro).
Therefore, based on the provided information, the StatStrip Glucose Hospital Meter System is clearly an In Vitro Diagnostic device.
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 neonate heel stick specimens.
The StatStrip Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal arterial samples throughout all hospital and all professional healthcare settings.
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 diabetes mellitus but is indicated for use in determining dysglycemia.
Product codes
PZI
Device Description
The StatStrip Glucose Hospital Meter System previously cleared under K060345, K063821, and K132121 is being modified to include a new ergonomic design and wireless (Wi-Fi) connectivity option. The new system, sold under a new ordering number with wireless option, contains the following:
-
- StatStrip Meter, with integrated Wi-Fi connection and antenna option
-
- Charging Station
-
- Vial of StatStrip Test Strips
-
- Battery (3.7 V Lithium)
-
- Quick Reference Guide
-
- Instructions for Use Manual
-
- StatStrip Log Book
Offered separately:
- StatStrip Test Strips .
- Quality Control solutions, Level 1, 2, 3 .
- Linearity Solutions, Levels 1,2,3,4,5 ●
Meter: The StatStrip Glucose Hospital Meter is a hand-held testing device that works in conjunction with Nova glucose-test strips to measure glucose in a whole blood sample. Meter operation is selfprompting using an illuminated touch-screen Graphical User Interface (GUI). In addition to measuring glucose, the meter also stores patient test data, quality control test data and other information relating to the patient, patient sample, operator, reagents and meter. The self-prompting menu system is navigated by means of a combination of touch-panel onscreen keys, on-screen soft keyboard. The operator can use a finger or a PDA style stylus to select options for the on-screen display. It offers audible feedback for user inputs, and audible and/or visual feedback for prompts and user alerts. The Meter also has a barcode scanner that automates data entry. The rechargeable batteries provide sufficient power to operate for 8 hours before requiring recharging. A "battery fuel gauge" bitmap constantly informs the user as to the current state of charge on the battery. Battery charge state information is available on the "meter Welcome screen". The meter will shutoff (Sleep) after 90 seconds of inactivity. Test data and meter setup information will be stored in a non-volatile form to prevent data loss.
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 for charging and a slot for an extra battery to be charged. 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.
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 process provides a blood glucose result. Test strips will be sold in vials of 25 strips.
Control Solutions: The control solutions are aqueous assayed solutions, containing buffered D-Glucose, viscosityadjusting 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.
Linearity Solutions: There are 5 levels of Linearity solutions containing buffered D-Glucose, viscosity-adjusting agent, preservatives and other non-reactive ingredients (dye). They contain no products of human origin. These solutions are offered separately from the system for users to verify the performance of the system.
Replacement batteries will be offered separately.
Wi-Fi Option: The StatStrip Glucose Hospital Meter with Wi-Fi option provides an additional communication method with a healthcare facility's network system. This new Wi-Fi capability to transmit data results and other information using Radio Frequency is wholly unrelated to any of the existing technology and functionality, i.e., operations performed for the glucose measurement cycle are identical to the predicate device. The design change of this new Wi-Fi communication method is offered on a new system as an option. i.e., the existing system without integrated Wi-Fi capability is still available. The primary difference between this new design and the cleared devices is an integrated Wi-Fi module using the IEEE 802.11 a/b/g communication protocol to transmit data.
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, neonate heel stick specimens.
Indicated Patient Age Range
Neonate
Intended User / Care Setting
Throughout all hospital and all professional healthcare settings.
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
Bench testing was completed to demonstrate that the modified StatStrip Glucose Hospital Meter System is substantially equivalent in performance, safety and efficacy to the currently cleared StatStrip Glucose Hospital Meter System (predicate device). The internal bench testing included: Method Comparison Studies, Precision Studies, Cleaning and Disinfection. Additional external testing was conducted in intended use environments. The results of the testing confirmed that the performance of the StatStrip Glucose Hospital Meter System with new ergonomic enhancements and Wi-Fi connectivity option is substantially equivalent to that of the StatStrip Glucose Hospital Meter System (predicate device).
Key Metrics
Not Found
Predicate Device(s)
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.
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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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 1. 2019
Nova Biomedical Corporation Paul MacDonald Chief Quality Assurance and Regulatory Affairs Officer 200 Prospect Street Waltham, MA 02454-9141
Re: K150281
Trade/Device Name: StatStrip Glucose Hospital Meter Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: PZI Dated: February 3, 2015 Received: February 5, 2015
Dear Paul MacDonald:
This letter corrects our substantially equivalent letter of May 6, 2015.
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 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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150281
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 neonate heel stick specimens.
The StatStrip Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal arterial samples throughout all hospital and all professional healthcare settings.
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 diabetes mellitus but is indicated for use in determining dysglycemia.
| 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
| 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: | Paul W. MacDonald | ||
| Date Prepared: | April 21, 2015 | ||
| Proprietary Name: | StatStrip Glucose Hospital Meter System | ||
| Common or Usual Name: | Glucose Oxidase, Glucose | ||
| Classification Name: | Multiple | ||
| Classification Names: | |||
| Glucose Test System | Class Panel No. | ||
| 75CGA | Reg. No. | ||
| 862.1345 | Class |
CGA Product Codes:
Predicate Device: StatStrip Glucose Hospital Meter System, K060345, K063821, and K132121.
Device Description:
The StatStrip Glucose Hospital Meter System previously cleared under K060345, K063821, and K132121 is being modified to include a new ergonomic design and wireless (Wi-Fi) connectivity option. The new system, sold under a new ordering number with wireless option, contains the following:
-
- StatStrip Meter, with integrated Wi-Fi connection and antenna option
-
- Charging Station
-
- Vial of StatStrip Test Strips
-
- Battery (3.7 V Lithium)
-
- Quick Reference Guide
-
- Instructions for Use Manual
-
- StatStrip Log Book
Offered separately:
- StatStrip Test Strips .
- Quality Control solutions, Level 1, 2, 3 .
- Linearity Solutions, Levels 1,2,3,4,5 ●
Meter
The StatStrip Glucose Hospital Meter is a hand-held testing device that works in conjunction with Nova glucose-test strips to measure glucose in a whole blood sample. Meter operation is selfprompting using an illuminated touch-screen Graphical User Interface (GUI). In addition to measuring glucose, the meter also stores patient test data, quality control test data and other information relating to the patient, patient sample, operator, reagents and meter.
The self-prompting menu system is navigated by means of a combination of touch-panel onscreen keys, on-screen soft keyboard. The operator can use a finger or a PDA style stylus to
4
select options for the on-screen display. It offers audible feedback for user inputs, and audible and/or visual feedback for prompts and user alerts. The Meter also has a barcode scanner that automates data entry.
The rechargeable batteries provide sufficient power to operate for 8 hours before requiring recharging. A "battery fuel gauge" bitmap constantly informs the user as to the current state of charge on the battery. Battery charge state information is available on the "meter Welcome screen". The meter will shutoff (Sleep) after 90 seconds of inactivity. Test data and meter setup information will be stored in a non-volatile form to prevent data loss.
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 for charging and a slot for an extra battery to be charged.
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.
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 process provides a blood glucose result. Test strips will be sold in vials of 25 strips.
Control Solutions
The control solutions are aqueous assayed solutions, containing buffered D-Glucose, viscosityadjusting 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.
Linearity Solutions
There are 5 levels of Linearity solutions containing buffered D-Glucose, viscosity-adjusting agent, preservatives and other non-reactive ingredients (dye). They contain no products of human origin. These solutions are offered separately from the system for users to verify the performance of the system.
Replacement batteries will be offered separately.
Wi-Fi Option
The StatStrip Glucose Hospital Meter with Wi-Fi option provides an additional communication method with a healthcare facility's network system. This new Wi-Fi capability to transmit data results and other information using Radio Frequency is wholly unrelated to any of the existing technology and functionality, i.e., operations performed for the glucose measurement cycle are identical to the predicate device.
The design change of this new Wi-Fi communication method is offered on a new system as an option. i.e., the existing system without integrated Wi-Fi capability is still available. The primary difference between this new design and the cleared devices is an integrated Wi-Fi module using the IEEE 802.11 a/b/g communication protocol to transmit data.
5
This 510(k) submission contains information and study data associated with the Wi-Fi module option and ergonomic design enhancements, and shows the modified StatStrip Glucose Hospital Meter System is substantially equivalent to the predicate device.
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 neonate heel stick specimens.
The StatStrip Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonate heel stick and neonatal arterial samples throughout all hospital and all professional healthcare settings.
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.
Summary of the Technological Characteristics:
The StatStrip Glucose Hospital Meter System with Wi-Fi option and new ergonomic design is substantially equivalent to the previously cleared StatStrip Glucose Hospital Meter System in intended use and technology. The new ergonomic meter design and Wi-Fi connectivity option do not introduce new concerns for safety and effectiveness. It uses the same sensor technology and measurement algorithms, and the formulations of the quality control and linearity solutions are identical.
6
| Characteristic | Predicate Device: Nova StatStrip Hospital Glucose Meter
(K060345, K063821, K132121) | Proposed: Device |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Name | StatStrip Glucose Hospital Meter System | Same |
| Indication For
Use/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 neonate heel stick specimens.
The StatStrip Glucose Hospital Meter System is also
intended for use in the quantitative determination of glucose
in venous whole blood, arterial whole blood, neonate heel
stick and neonatal arterial samples throughout all hospital
and all professional healthcare settings.
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. | Same |
| Measuring
Range | 10-600 mg/dL | Same |
| Hematocrit
Range | 20-65% | Same |
| Operating
Principle | Electrochemical biosensor | Same |
| Sample type | Capillary whole blood (finger stick), venous whole blood,
arterial whole blood, neonate heel stick, and neonate arterial
whole blood specimens
Venous whole blood, arterial whole blood, neonatal heel
stick, and neonatal arterial whole blood samples throughout
all hospital and all professional healthcare settings | Same |
| Sample size | 1.2 μL | Same |
| Sample
application | Test strip capillary draw | Same |
| Handheld? | Yes | Same |
| Calibration | Automatic, no Calibration Code | Same |
| Data Storage | 1,000 patient / 200 QC test results | Same |
| Test time to
result | 6 seconds | Same |
| Barcode
scanner | Yes | Same |
| Power source | Rechargeable 3.7 volt Lithium battery | Same |
| Meter size and
weight | 153 mm (6.0 in) x 82.5 mm (3.25 in) x 46 mm (1.8 in)
266 grams (0.6 lb) | 146 mm (5.8 in) x
79 mm (3.1 in) x |
| Characteristic | Predicate Device: Nova StatStrip Hospital Glucose Meter
(K060345, K063821, K132121) | Proposed: Device |
| | | 30 mm (1.18 in)
220 grams (0.49 lb) |
| Test Strips –
Active reagent: | Glucose Oxidase | Same |
| Quality
Controls | Liquid, 3 levels | Same |
| Linearity | Liquid, 5 levels | Same |
| Docking
Station? | Single station only | Single, dual, and
quad stations |
| Strip ejector
button | None | Yes |
| Wi-Fi Network
Connectivity | None | Yes |
Table 1: Comparison of Predicate and Proposed devices
7
Summary of Performance Testing:
Bench testing was completed to demonstrate that the modified StatStrip Glucose Hospital Meter System is substantially equivalent in performance, safety and efficacy to the currently cleared StatStrip Glucose Hospital Meter System (predicate device).
The internal bench testing included:
- Method Comparison Studies ●
- . Precision Studies
- . Cleaning and Disinfection
Additional external testing was conducted in intended use environments.
The results of the testing confirmed that the performance of the StatStrip Glucose Hospital Meter System with new ergonomic enhancements and Wi-Fi connectivity option is substantially equivalent to that of the StatStrip Glucose Hospital Meter System (predicate device).
Conclusion:
The results of software validation and performance verification testing confirmed that the StatStrip Glucose Hospital Meter System with new ergonomic enhancements and Wi-Fi connectivity option is safe and effective for its intended use and purpose and that the system is substantially equivalent to that of the predicate device.