(84 days)
No
The description focuses on standard glucose measurement technology and data management features. There is no mention of AI or ML algorithms being used for analysis, interpretation, or prediction.
No
This device is for in vitro diagnostic use, specifically for the quantitative determination of glucose, and is not described as providing treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "in vitro diagnostic" use and is "indicated for use in determining dysglycemia."
No
The device description explicitly lists multiple hardware components including a meter, charging station, battery, and test strips, in addition to 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, neonate arterial whole blood, and neonate heel stick specimens". The phrase "in vitro diagnostic" is a direct indicator.
- Device Description: The description details a system that analyzes biological samples (whole blood) outside of the body to provide a diagnostic result (glucose level). This is the core function of an in vitro diagnostic device.
- Components: The system includes components typical of an IVD, such as a meter, test strips (which contain reagents that react with the sample), and control solutions (used to verify the performance of the test).
- Performance Studies: The document describes clinical studies where the device's performance is compared to a central laboratory comparator method using patient samples. This is a standard part of the regulatory process for IVDs to demonstrate accuracy and reliability.
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, 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 diabetes mellitus but is indicated for use in determining dysglycemia.
Product codes
PZI
Device Description
The StatStrip Glucose Hospital Meter System was previously cleared under K150281. The purpose of this dual 510(k) and CLIA Waiver submission for the StatStrip Glucose Hospital Meter System is to expand the indication for use to include the use of capillary specimens on patients receiving intensive medical intervention/therapy and support a CLA Waived categorization for this expanded indication for use to include the quantitative determination of glucose in capillary finger stick throughout all hospital and all professional healthcare settings. No changes have been made to the software, the test strips, controls or linearity solutions.
The system 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 StatStrip 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 on-screen keys, on-screen soft keyboard. The operator can use a finger or a PDA stylus to select options for the onscreen 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 nonvolatile 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 ferricvanide 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, 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.
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 provides a Wi-Fi communication method with a healthcare facility's network system. The wireless radio chipset utilizing the IEEE 802.11 alb/g communication protocols (Wi-Fi) is used as an optional means to transmit and receive test results, previously cleared under K150281.
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
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Intended User / Care Setting
point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous 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.
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
Summary of the Clinical Study Data:
Nova Biomedical conducted a large multi-center study of the StatStrip Glucose Hospital Meter System at two (2) leading medical centers to demonstrate the clinical performance of capillary whole blood specimens obtained by finger stick within critical care hospital settings on patients receiving intensive medical intervention/therapy. StatStrip capillary glucose specimens were compared to plasma glucose specimens obtained from either an arterial or venous specimen within 15 minutes of the capillary specimen as measured on a central laboratory comparator method. Clinical Study Site #1 was a CLIA Waived prospective study and the other 2 studies conducted in Site #3 were CLIA Waived retrospective studies designed to assess real world clinical performance throughout all hospital and all professional healthcare settings. Study Site #1 and #3 is one of the top ranked hospitals in Diabetes & Endocrinology located in Minnesota and study Site #2 is one the world's preeminent healthcare institutions located in Maryland. A description of the clinical study is found below. All central laboratory comparisons were against an IDMS traceable hexokinase comparator method (Roche Cobas System, Roche Diagnostics, Indianapolis, IN).
Prospective Clinical Study
The prospective capillary critical study (Site #1) included 568 critical care patients undergoing intensive medical intervention/therapy within 3 critical care departments (CVCU, MICU and OR). The critical care patients from the CVICU and MCU included 80 unique patient conditions receiving a total of 3,785 medications representing 17 parent drug classes. Medical conditions were unavailable for critical care patients in the OR.
Real World Evidence Studies
The purpose of these studies was to retrospectively data mine real world evidence on the performance of StatStrip glucose with capillary whole blood specimens obtained by skin puncture from adult and pediatric patients in Intensive Care Units (ICUs) on critically ill patients receiving Intensive Medical Intervention/Therapy as compared to plasma glucose obtained from either an arterial or venous specimen. These real world retrospective studies were conducted by CLIA Waived operators within these healthcare settings. The CLIA Waived operators were qualified to use the StatStrip system per institutional requirements in these critical care settings.
Real World Study Site Breakdown
Clinical Study #2 was a real world clinical review of 2,133 critical care patients throughout all critical care settings that had a glucose test performed using a capillary whole blood specimen obtained by finger stick and a plasma glucose test obtained from either an arterial or venous specimen performed in the central laboratory within 15 minutes of the capillary test. Medical conditions were unavailable for critical care patients in this study.
Clinical Study #3 was a real world clinical review of 14,645 critical care patients throughout all critical care settings that had a glucose test performed using a capillary whole blood specimen obtained by finger stick and a plasma glucose test obtained from either an arterial or venous specimen performed in the central laboratory within 15 minutes of the capillary test. Medical conditions were unavailable for critical care patients in this study.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Study Performance
Study #1 (Prospective Study)
Fingertip capillary samples with 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.
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 in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
July 12, 2018
Nova Biomedical Corporation John Mchale VP of RA/QA and Technical Support 200 Prospect Street Waltham, MA 02454
Re: K181043
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: April 18, 2018 Received: April 19, 2018
Dear John Mchale:
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. 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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR
1
Part 820); 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,
Kellie B. Kelm -S
Courtney H. Lias, Ph.D. for 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)
K181043
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, 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 diabetes mellitus but is indicated for use in determining dysglycemia.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
[X] 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) Number: K181043
| 510(k) Owner: | Nova Biomedical Corporation |
|---|---|
| Registration Number: | 1219029 |
| Address: | 200 Prospect St. |
| Waltham, MA 02453 | |
| Fax Number: | 784-891-4806 |
| Contact Person: | John F. Mchale |
| Phone: | 781-894-0800 |
| Date Prepared: | July 3, 2018 |
Proprietary Name: StatStrip Glucose Hospital Meter System
Common or Usual Name: Blood Glucose Meter
Product Code: PZI
Classification Name:
| Classification Name | Class No. | Regulation No. | Class |
|---|---|---|---|
| Prescription Use Blood Glucose Meter For | |||
| Near-Patient Testing | 75 PZI | 862.1345 | II |
Predicate Device: StatStrip Glucose Hospital Meter System, K150281.
Device Description:
The StatStrip Glucose Hospital Meter System was previously cleared under K150281. The purpose of this dual 510(k) and CLIA Waiver submission for the StatStrip Glucose Hospital Meter System is to expand the indication for use to include the use of capillary specimens on patients receiving intensive medical intervention/therapy and support a CLA Waived categorization for this expanded indication for use to include the quantitative determination of glucose in capillary finger stick throughout all hospital and all professional healthcare settings. No changes have been made to the software, the test strips, controls or linearity solutions.
The system 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 StatStrip 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
4
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 on-screen keys, on-screen soft keyboard. The operator can use a finger or a PDA stylus to select options for the onscreen 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 nonvolatile 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 ferricvanide 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, 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.
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 provides a Wi-Fi communication method with a healthcare facility's network system. The wireless radio chipset utilizing the IEEE 802.11 alb/g communication protocols (Wi-Fi) is used as an optional means to transmit and receive test results, previously cleared under K150281.
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
5
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.
lt 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 dysqlycemia.
Summary of the Technological Characteristics:
The StatStrip Glucose Hospital Meter System has the same scientific technology as the predicate. No changes have been made to the meter, the software, the controls or the linearity solutions. The only change is to the labeling of the device to allow the product to be used on capillary samples in critical care patient settings. The StatStrip Glucose Hospital Meter System is substantially equivalent to the StatStrip Glucose Hospital Meter System.
Summary of the Clinical Study Data:
Nova Biomedical conducted a large multi-center study of the StatStrip Glucose Hospital Meter System at two (2) leading medical centers to demonstrate the clinical performance of capillary whole blood specimens obtained by finger stick within critical care hospital settings on patients receiving intensive medical intervention/therapy. StatStrip capillary glucose specimens were compared to plasma glucose specimens obtained from either an arterial or venous specimen within 15 minutes of the capillary specimen as measured on a central laboratory comparator method. Clinical Study Site #1 was a CLIA Waived prospective study and the other 2 studies conducted in Site #3 were CLIA Waived retrospective studies designed to assess real world clinical performance throughout all hospital and all professional healthcare settings. Study Site #1 and #3 is one of the top ranked hospitals in Diabetes & Endocrinology located in Minnesota and study Site #2 is one the world's preeminent healthcare institutions located in Maryland. A description of the clinical study is found below. All central laboratory comparisons were against an IDMS traceable hexokinase comparator method (Roche Cobas System, Roche Diagnostics, Indianapolis, IN).
Prospective Clinical Study
The prospective capillary critical study (Site #1) included 568 critical care patients undergoing intensive medical intervention/therapy within 3 critical care departments (CVCU, MICU and OR). The critical care patients from the CVICU and MCU included 80 unique patient conditions receiving a total of 3,785 medications representing 17 parent drug classes. Medical conditions were unavailable for critical care patients in the OR.
Real World Evidence Studies
The purpose of these studies was to retrospectively data mine real world evidence on the performance of StatStrip glucose with capillary whole blood specimens obtained by skin puncture from adult and pediatric patients in Intensive Care Units (ICUs) on critically ill patients receiving Intensive Medical Intervention/Therapy as compared to plasma glucose obtained from either an arterial or venous specimen. These real world retrospective studies were conducted by CLIA Waived operators within these healthcare settings. The CLIA Waived operators were qualified to use the StatStrip system per institutional requirements in these critical care settings.
Real World Study Site Breakdown
Clinical Study #2 was a real world clinical review of 2,133 critical care patients throughout all critical care settings that had a glucose test performed using a capillary whole blood specimen obtained by finger stick and a plasma glucose test obtained from either an arterial or venous specimen performed in the
6
central laboratory within 15 minutes of the capillary test. Medical conditions were unavailable for critical care patients in this study.
Clinical Study #3 was a real world clinical review of 14,645 critical care patients throughout all critical care settings that had a glucose test performed using a capillary whole blood specimen obtained by finger stick and a plasma glucose test obtained from either an arterial or venous specimen performed in the central laboratory within 15 minutes of the capillary test. Medical conditions were unavailable for critical care patients in this study.
Clinical Study Performance
Study #1 (Prospective Study)
| Fingertip capillary samples with glucose concentrations