(110 days)
The StatStrip Xpress 2 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 Xpress 2 Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal 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.
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 dysglycemia.
The StatStrip Xpress Glucose Hospital Meter System previously cleared under K070960 and K150461 is being modified to include a 2.2 inch color graphics display and an updated ergonomic design. The new system will be sold as the StatStrip Xpress 2 Glucose Hospital Meter System.
The intended use of the modified StatStrip Xpress 2 Glucose Hospital Meter System has not changed as a result of the modifications.
The StatStrip Xpress 2 Glucose Hospital Meter utilizes a 2.2" color graphics display in place of the segmented display that is currently used in the predicate StatStrip Xpress Glucose Hospital Meter. The color screen allows for the user interface to be displayed in a more modern format; however the overall screen content of the meter will remain unchanged from the predicate device. The StatStrip Xpress 2 Glucose Hospital Meter will utilize the same screen progressions and user workflow as the predicate device. The StatStrip Xpress 2 Glucose Hospital Meter utilizes the same three button keypad design as the predicate to navigate the user interface.
To support the increased power requirements of the color display, the newly designed StatStrip Xpress 2 Glucose Hospital Meter will be powered by two AAA batteries in place of the single Li 2450 coin cell battery used in the predicate StatStrip Xpress Glucose Hospital Meter.
The StatStrip Xpress 2 Glucose Hospital Meter uses identical signal processing and results generating methods and stores test results in the same manner as the predicate device.
The StatStrip Xpress 2 Glucose Hospital Meter's new ergonomic design introduces a flat, top surface design that eliminates ridges, recessed corners and raised edges. The strip port has been moved to the bottom of StatStrip Xpress 2 Glucose Hospital Meter in order to increase customer satisfaction. The new location of the strip port reduces the chance of control material entering the strip port. The StatStrip Xpress 2 Glucose Hospital Meter utilizes the same strip port and electronics for making glucose measurements as the predicate device. The proposed device has the same performance characteristics as the predicate device.
The provided text describes modifications to an existing device, the StatStrip Xpress Glucose Hospital Meter System, to create the StatStrip Xpress 2 Glucose Hospital Meter System. The primary changes are an updated 2.2-inch color graphics display, an updated ergonomic design, and a change in battery type. The document explicitly states that the intended use, sensor technology, measurement electronics, measurement algorithms, test strip formulations, product manufacturing, and quality control remain the same as the predicate device. Therefore, the performance characteristics are expected to be identical to the predicate device.
Given that the current submission is for modifications to an already cleared device and not a de novo submission for a new device, the document does not contain new studies to establish acceptance criteria or device performance for the StatStrip Xpress 2 beyond what was previously established for its predicate. It relies on the substantial equivalence to the previously cleared device (K070960 and K150461).
As such, I cannot provide a table of acceptance criteria and reported device performance, nor details on new studies, as these were not conducted for this specific submission. The document's focus is on demonstrating that the modifications do not introduce new concerns for safety and effectiveness and that the new device maintains the performance characteristics of its predicate.
To answer your request, I will extract relevant information about the predicate device's characteristics as implied by the substantial equivalence claim.
Here's a breakdown based on the information provided in the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a new table of acceptance criteria and reported device performance for the StatStrip Xpress 2 Glucose Hospital Meter System. It asserts that the proposed device has the same performance characteristics as the predicate device (StatStrip Xpress Glucose Hospital Meter System, K150461 and K070960), due to identical sensor technology, measurement electronics, measurement algorithms, and test strip/control/linearity solution formulations.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no new clinical or performance studies are described for the StatStrip Xpress 2 in this submission. The claim is based on the previously established performance of the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no new clinical or performance studies are described for the StatStrip Xpress 2 in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new clinical or performance studies are described for the StatStrip Xpress 2 in this submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is an in vitro diagnostic device for glucose measurement, not an AI-assisted diagnostic imaging device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a standalone glucose meter. Its performance is evaluated intrinsically against laboratory reference methods. The document states: "It is intended to provide plasma equivalent results to laboratory methods." This implies that the standalone performance was established during the clearance of the predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the predicate device, the implied ground truth for glucose measurement is a laboratory reference method. The statement "It is intended to provide plasma equivalent results to laboratory methods" supports this.
8. The sample size for the training set
Not applicable. This device relies on established electrochemical principles, not machine learning or AI models with training sets.
9. How the ground truth for the training set was established
Not applicable, as no training set (in the machine learning sense) is mentioned.
Summary based on the provided document:
The FDA 510(k) submission for the StatStrip Xpress 2 Glucose Hospital Meter System did not require new studies to prove acceptance criteria because the device is a modified version of a previously cleared predicate device. The core measurement technology, algorithms, and intended use remain unchanged. Therefore, the performance characteristics of the StatStrip Xpress 2 are considered substantially equivalent to its predicate. The document implicitly relies on the studies and performance data submitted for the clearance of the predicate devices (K070960 and K150461) to demonstrate the StatStrip Xpress 2's effectiveness and safety.
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March 1, 2019
Nova Biomedical Corporation Paul MacDonald 200 Prospect Street Waltham, MA 02454
Re: K152986
Trade/Device Name: StatStrip Xpress 2 Glucose Hospital Meter System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: PZI Dated: December 22, 2015 Received: December 28, 2015
Dear Paul MacDonald:
This letter corrects our substantially equivalent letter of January 27, 2016.
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.
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
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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.htm); 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 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 medical devices and radiation-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
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Indications for Use
510(k) Number (if known)
Device Name
StatStrip Xpress 2 Glucose Hospital Meter System
Indications for Use (Describe)
The StatStrip Xpress 2 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 Xpress 2 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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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: | September 30, 2015 |
Proprietary Name: StatStrip Xpress 2 Glucose Hospital Meter System
Common or Usual Name: Blood Glucose Meter
Requlatory Information:
Regulatory Panel: Clinical Chemistry Requlatory Number: 21CFR 862.1345 Device Class: II Product Code: CGA, Glucose Oxidase, Glucose
Predicate Device: K150461-StatStrip Xpress Glucose Hospital Meter System
Device Description:
The StatStrip Xpress Glucose Hospital Meter System previously cleared under K070960 and K150461 is being modified to include a 2.2 inch color graphics display and an updated ergonomic design. The new system will be sold as the StatStrip Xpress 2 Glucose Hospital Meter System.
The intended use of the modified StatStrip Xpress 2 Glucose Hospital Meter System has not changed as a result of the modifications.
The StatStrip Xpress 2 Glucose Hospital Meter utilizes a 2.2" color graphics display in place of the segmented display that is currently used in the predicate StatStrip Xpress Glucose Hospital Meter. The color screen allows for the user interface to be displayed in a more modern format; however the overall screen content of the meter will remain unchanged from the predicate device. The StatStrip Xpress 2 Glucose Hospital Meter will utilize the same screen progressions and user workflow as the predicate device. The StatStrip Xpress 2 Glucose Hospital Meter utilizes the same three button keypad design as the predicate to navigate the user interface.
To support the increased power requirements of the color display, the newly designed StatStrip Xpress 2 Glucose Hospital Meter will be powered by two AAA batteries in place of the single Li 2450 coin cell battery used in the predicate StatStrip Xpress Glucose Hospital Meter.
The StatStrip Xpress 2 Glucose Hospital Meter uses identical signal processing and results generating methods and stores test results in the same manner as the predicate device.
The StatStrip Xpress 2 Glucose Hospital Meter's new ergonomic design introduces a flat, top surface design that eliminates ridges, recessed corners and raised edges. The strip port has been moved to the bottom of StatStrip Xpress 2 Glucose Hospital Meter in order to increase customer satisfaction. The new location of the strip port reduces the chance of control material entering the strip port. The StatStrip Xpress 2 Glucose Hospital Meter utilizes the same strip port and electronics for making glucose measurements as the predicate device. The proposed device has the same performance characteristics as the predicate device.
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Meter
The StatStrip Xpress 2 Glucose Hospital Meter System is specifically designed to meet the bedside and point-of-care glucose testing needs in today's hospital environment. The system is intended for in vitro diagnostic use by health care professionals for both clinical and point-of-care usage for the quantitative determination of glucose in whole blood. It is intended to provide plasma equivalent results to laboratory methods. The StatStrip Xpress 2 Glucose Hospital Meter System is intended for use in a clinical setting by healthcare professionals as an aid to monitor qlucose levels in the management of dysqlycemia. The StatStrip Xpress 2 Glucose Hospital Meter is a hand-held testing device that works in conjunction with the StatStrip Glucose Test Strips. Meter operation is self-prompting using a new 2.2 inch color graphics display. Function and data selection is accomplished using 3 push buttons. The handheld meter supports audible alerts and prompts with a built-in beeper. In addition to measuring qlucose, the meter also stores up to 400 patient test records. The user can recall and review test results.
Two AAA batteries power the device, and are expected to perform up to 600 tests before needing to be replaced. A low battery prompt will appear when it is time to replace the battery. All test data is stored in a non-volatile form to prevent data loss.
Test Strips
The StatStrip Glucose Hospital Meter Test Strips that are the subject of this submission are identical in form, fit, function and packaging, to the glucose test strips currently cleared for use with the StatStrip Xpress Glucose Hospital Meter System (K070960, K150461). The Test Strip is designed with an electrode that measures Glucose in the blood sample mixes with reagent on the test strip that produces an electric current. The amount of current that is produced depends on how much Glucose is in the blood.
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 cartons of 100 strips (50 strips/vial).
Contents:
Each glucose test strips contain a reaction layer that contains glucose enzyme (Aspergillus sp.) >1.0 IU, mediator ≥ 20 uq, and other nonreactive substances.
Function:
StatStrip Glucose Test Strips are intended for quantitative determination of Glucose in fresh whole blood specimens. StatStrip Glucose Test Strips are for use only with the StatStrip Family of Meters.
Storage Conditions:
Store the test strips in the vial between 34-86°F (1-30°C). Ensure that the vial is closed between uses. Once opened the test strips in the vial may be used for 180 days or until the expiration date printed on the label, whichever comes first.
Controls and Linearity Solutions
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The StatStrip Control and Linearity Solutions that are intended for use with the system are identical in formulation and packaging, to the Control and Linearity Solutions originally cleared for use with the StatStrip Xpress Glucose Hospital Meter System in K070960.
Control Solutions
The StatStrip Control Solutions are aqueous solutions that contain no products of human origin. The controls solutions are for use with all of the StatStrip Meters.
Contents:
Each vial contains approximately 4mLs of a buffered aqueous control solution containing qlucose, Bketone, preservative, viscosity-adjusting agent and other non-reactive ingredients (dye).
There are three levels of control solutions (Levels 1-3).
Function:
StatStrip Glucose Control Solutions are intended to verify the accuracy of the blood Glucose test results.
Storage Conditions:
Store the control solution in the vial at room temperature; 59°F-86°F (15°C-30°C). Ensure that the vial is closed between use. Once opened the control solution may be used for up to 3 months or until the expiration date printed on the label, whichever comes first.
Linearity Solutions
The StatStrip Glucose Linearity Solutions are aqueous materials with a known concentration of glucose intended to verify performance of the StatStrip Meters.
Assay values for expected ranges are included on every bottle of linearity standards. If the results obtained are outside the expected range, the system may not be performing correctly.
Contents:
Each vial contains 4mLs of a buffered glucose, β-ketone, preservative, viscosity-adjusting agent and other non-reactive ingredients (dye). They contain no products of human origin.
There are five levels of linearity solutions (Levels 1-5).
Function:
The Linearity Solution is intended for monitoring the performance (linearity) of the StatStrip Glucose Hospital Meter System.
Storage Conditions:
Store the linearity solution in the vial at room temperature; 5995-86°F (15°C-30°C). Ensure that the vial is closed between uses. Once opened the control solution may be used for up to 3 months or until the expiration date printed on the label, whichever comes first.
Intended Use:
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The StatStrip Xpress 2 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 Xpress 2 Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal 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.
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 dysglycemia.
Summary of the Technological Characteristics:
The StatStrip Xpress 2 Glucose Hospital Meter System is substantially equivalent to the previously cleared StatStrip Xpress Glucose Hospital Meter System in intended use and technology. All test results are stored and recalled in the same manner as the predicate device. The new meter design and color screen do not introduce new concerns for safety and effectiveness. It uses the same sensor technology, measurement electronics and measurement algorithms, and the formulations of the glucose test strips, quality control and linearity solutions are identical.
§ 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.