(87 days)
The StatStrip Xpress 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 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 Xpress Glucose Hospital Meter is a hand-held, battery-powered, in vitro diagnostic laboratory instrument that works in conjunction with Nova Biomedical glucose electrochemical test strips to measure glucose in a whole blood sample, Quality Control (QC), linearity, or proficiency solutions. In addition to measuring glucose, the meter stores patient test data, and other information relating to patient sample, operator, reagents, and the meter. The meter can store up to 400 patient and/or quality control test results. The user can review all stored test results on screen. Functions and data selection are accomplished by 3 push buttons. The meter has a built-in beeper for audible alerts and prompts.
The StatStrip Glucose Hospital Meter Test Strips are intended for use with the StatStrip Xpress Glucose Hospital Meter System.
The Nova StatStrip Glucose Control Solutions are used as a quality control check to ensure that the StatStrip Xpress Glucose Hospital Meter and the Glucose Test Strips are working properly as a system.
The Nova StatStrip Glucose Linearity Solutions are used to check the linearity of the Nova StatStrip Xpress Glucose Hospital Meter.
This is a 510(k) summary for the StatStrip Xpress Glucose Hospital Meter System. This document focuses on the claim of substantial equivalence to a predicate device and an expanded indication for use.
Here's an analysis based on your request, but it's important to note that this document is primarily a clearance letter and 510(k) summary, not a detailed study report. Therefore, much of the information regarding specific study methodologies (like sample sizes for test sets, expert details, adjudication methods, MRMC studies, or standalone performance study details) is not present in this document.
Device: StatStrip Xpress Glucose Hospital Meter System
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a table format for performance metrics. Instead, it relies on the device being "substantially equivalent" to a predicate device and having an expanded indication that was already cleared for the predicate.
The reported performance characteristics (which are the same as the predicate device) are:
| Item | Reported Device Performance (StatStrip Xpress Glucose Hospital Meter System) |
|---|---|
| Intended Use | Quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood, and neonate heel stick specimens in all hospital and professional healthcare settings, including patients receiving intensive medical intervention/therapy. (Note: This is the expanded indication based on the predicate device's clearance). |
| Operating Principle | Electrochemical biosensor |
| Measuring Technology | Enzyme, Amperometric Glucose Enzyme (Aspergillus sp., >1.0 IU) |
| Sample Type | Capillary whole blood (finger stick), venous whole blood, arterial whole blood, neonatal heel stick, and neonatal arterial whole blood samples |
| Sample Size | 1.2 μL |
| Sample Application | Test strip capillary draw |
| Measuring Range | 10-600 mg/dL |
| Hematocrit Range | 20-65% |
| Reported Output | mg/dL |
| Time to Result | ~ 6 seconds |
| Calibration | Automatic, no Calibration Code |
| Test Strip Active Reagent | Glucose Oxidase |
| Quality Control | 3 levels |
| Linearity | 5 levels |
| Handheld | Yes |
| Data Storage | 400 patient, quality control, linearity, and proficiency tests (Note: This differs from the predicate which stored 1000 patient tests, 200 QC, 4000 operators) |
| Barcode | No (Note: This differs from the predicate which had a barcode feature) |
| Power Source | 3V dc Li coin cell battery (Note: This differs from the predicate which used a Rechargeable 3.7 volt Lithium battery) |
| Operating Temp | 41° to 104°F (5° to 40°C) (Note: This differs from the predicate which was 59°F - 104°F (15°C - 40°C)) |
Note on Acceptance Criteria: The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to the predicate device (StatStrip Glucose Hospital Meter System, K181043) and justifying that the expanded indication (for capillary whole blood specimens in all hospital and healthcare settings) was already cleared for the predicate. The document states "No changes have been made to the candidate device, the software, the test strips, controls or linearity solutions since the K161856 clearance therefore; there are no additional safety and efficacy concerns to the device." This implies that the performance data previously used to clear K161856 and K181043 are sufficient. Specific numerical acceptance criteria for accuracy (e.g., % within +/-X mg/dL) are not detailed here.
2. Sample Size for the Test Set and Data Provenance
The document does not provide details on the sample size used for a specific test set in this submission. It focuses on the fact that no changes were made to the device itself since previous clearances (K161856), and the expanded indication was already cleared for the predicate (K181043). Therefore, specific new test data for this 510(k) submission are not presented.
The data provenance is not mentioned. Typically, clinical studies for medical devices are conducted in multiple geographical locations sometimes, but this is not specified here. It's likely within the US, but not confirmed. The document does not specify if data was retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth
This information is not provided in this 510(k) summary. For a blood glucose meter, the "ground truth" (reference method) is usually a laboratory-based glucose analyzer, not an expert consensus.
4. Adjudication Method for the Test Set
This information is not applicable/provided in this 510(k) summary. Adjudication methods are typically relevant for subjective assessments, such as image interpretation, not for quantitative measurements like blood glucose.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is not applicable for a blood glucose meter, as it is a quantitative measurement device, not an interpretation device that benefits from human readers.
6. Standalone (Algorithm Only) Performance Study
This document describes a device (blood glucose meter and test strips) that performs a direct measurement. Its "standalone performance" is its accuracy and precision against a reference method. While the document implies this was evaluated for previous clearances, no specific standalone study details (e.g., accuracy against a lab reference method) are provided within this particular 510(k) summary. It refers to prior clearances (K150461 and K161856) for performance.
7. Type of Ground Truth Used
For blood glucose measurements, the ground truth is typically established by a laboratory reference method (e.g., a central laboratory analyzer using an enzymatic reference method). This is standard for glucose meters.
8. Sample Size for the Training Set
This information is not provided in this 510(k) summary. Given that the device relies on an electrochemical biosensor and enzyme-based measurement, rather than a complex algorithm developed through machine learning, the concept of a "training set" in the context of AI/ML is not directly applicable. The device's calibration and performance are established through manufacturing controls, quality control, and clinical validation studies (which typically would use patient samples, but these are not referred to as a "training set" for an algorithm in this context).
9. How the Ground Truth for the Training Set Was Established
As mentioned above, the concept of a "training set" in the AI/ML sense is not directly applicable here. The ground truth for establishing the performance of such a device would be based on comparison to a highly accurate laboratory reference method for glucose measurement, which would be part of the validation for the electrochemical biosensor system. Specific details for this device are not in this document.
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December 13, 2018
Nova Biomedical Corporation Khushboo Surendran 200 Prospect Street Waltham, MA 02454
Re: K182552
Trade/Device Name: StatStrip Xpress Glucose Hospital Meter System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: PZI Dated: September 14, 2018 Received: September 17, 2018
Dear Khushboo Surendran:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if
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.
applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-
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,
Kellie B. Kelm -S
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) K182552
Device Name
StatStrip Xpress Glucose Hospital Meter System
Indications for Use (Describe)
The StatStrip Xpress 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 throughout all hospital and all professional healtheare 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.
X 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: K182552
| 510(k) Owner: | Nova Biomedical Corporation |
|---|---|
| Registration Number: | 1219029 |
| Address: | 200 Prospect St. |
| Waltham, MA 02454 | |
| Fax Number: | 784-891-4806 |
| Contact Person: | Khushboo Surendran |
| Phone: | 781-894-0800 |
| Date Prepared: | September 14, 2018 |
Proprietary Name: StatStrip Xpress 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 ForNear-Patient Testing | 75 PZI | 862.1345 | II |
Predicate Device: StatStrip Glucose Hospital Meter System, K181043.
Device Description:
The purpose of this submission is to change the labeling the indication for use statement to include the use of capillary whole blood specimens throughout all hospital and all professional healthcare settings, including patients receiving intensive medical intervention/therapy. This expanded indication was previously cleared for the predicate device, StatStrip Glucose Hospital Meter System in K181043. No changes have been made to the candidate device, the test strips, controls or linearity solutions since the clearance in K161856.
Meter:
The StatStrip Xpress Glucose Hospital Meter is a hand-held, battery-powered, in vitro diagnostic laboratory instrument that works in conjunction with Nova Biomedical glucose electrochemical test strips to measure glucose in a whole blood sample, Quality Control (QC), linearity, or proficiency solutions. In addition to measuring glucose, the meter stores patient test data, and other information relating to patient sample, operator, reagents, and the meter. The meter can store up to 400 patient and/or quality control test results. The user can review all stored test results on screen. Functions and data selection are accomplished by 3 push buttons. The meter has a built-in beeper for audible alerts and prompts.
Test Strips:
The StatStrip Glucose Hospital Meter Test Strips are intended for use with the StatStrip Xpress Glucose Hospital Meter System. No changes have been made to the form, fit, function or packaging of StatStrip Glucose Hospital Meter Test Strips since K070960 clearance and they are not a subject of this submission.
Control Solutions:
The Nova StatStrip Glucose Control Solutions are used as a quality control check to ensure that the StatStrip Xpress Glucose Hospital Meter and the Glucose Test Strips are working properly as a system.
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No changes have been made to the form, fit, function or packaging of the Nova StatStrip Glucose Control Solution since K070960 clearance and they are not a subject of this submission.
Linearity Solutions:
The Nova StatStrip Glucose Linearity Solutions are used to check the linearity of the Nova StatStrip Xpress Glucose Hospital Meter. No changes have been made to the form, fit, function or packaging of the Nova StatStrip Glucose Linearity Solution since K070960 clearance and they are not a subject of this submission.
Principle of Test
The Test Strip is designed with an electrode that measures glucose (sugar) 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 StatStrip Xpress Glucose Hospital Meter System with StatStrip Glucose Hospital Meter Test Strip measures the glucose level in blood. The glucose result is displayed on the screen of the meter. The test strip is calibrated against plasma.
Intended Use:
The StatStrip Xpress 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 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.
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 Xpress Glucose Hospital Meter System uses the exact same technology, operating principle, software measurement algorithm and user workflow as the predicate device, StatStrip Glucose Hospital Meter System (K181043).
The StatStrip Xpress Glucose Hospital Meter System was recently cleared under K150461 by demonstrating substantially equivalent performance to the StatStrip Glucose Hospital Meter System.
The only proposed change is to the labeling of the device to allow the product to be used on capillary whole blood specimens throughout all hospital and all professional healthcare settings, including patients receiving intensive medical intervention/therapy.
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Comparison of Predicate and Candidate devices
| Item | Predicate Device (K181043)StatStrip Glucose Hospital MeterSystem | Candidate DeviceStatStrip Xpress Glucose Hospital MeterSystem |
|---|---|---|
| Intended Use | The StatStrip Glucose Hospital Meter Systemis intended for point-of-care, in vitrodiagnostic, multiple-patient use for thequantitative determination of glucose incapillary finger stick, venous whole blood,arterial whole blood, neonate arterial wholeblood, and neonate heel stick specimensthroughout all hospital and all professionalhealthcare settings, including patientsreceiving intensive medical interven-tion/therapy.The system should only be used with single-use, auto-disabling lancing devices whenperforming a capillary finger stick or neonateheel stick.It is not intended for use with neonate cordblood specimens.It is not intended for the screening ordiagnosis of diabetes mellitus but is indicatedfor use in determining dysglycemia. | The StatStrip Xpress Glucose Hospital MeterSystem is intended for point-of-care, in vitrodiagnostic, multiple-patient use for thequantitative determination of glucose incapillary finger stick, venous whole blood,arterial whole blood, neonate arterial wholeblood, and neonate heel stick specimensthroughout all hospital and all professionalhealthcare settings, including patientsreceiving intensive medical interven-tion/therapy.The system should only be used with single-use, auto-disabling lancing devices whenperforming a capillary finger stick or neonateheel stick.It is not intended for use with neonate cordblood specimens.It is not intended for the screening ordiagnosis of diabetes mellitus but is indicatedfor use in determining dysglycemia. |
| OperatingPrinciple | Electrochemical biosensor | Same |
| MeasuringTechnology | Enzyme, Amperometric Glucose Enzyme(Aspergillus sp., >1.0 IU) | Same |
| Sample type | Capillary whole blood (finger stick), venouswhole blood, arterial whole blood, neonatalheel stick, and neonatal arterial whole bloodsamples | Same |
| Sample size | 1.2 μL | Same |
| Sampleapplication | Test strip capillary draw | Same |
| Measuringrange | 10-600 mg/dL | Same |
| Hematocritrange | 20-65% | Same |
| Item | Predicate Device (K181043)StatStrip Glucose Hospital MeterSystem | Candidate DeviceStatStrip Xpress Glucose Hospital MeterSystem |
| Reportedoutput | mg/dL | Same |
| Time to Result | ~ 6 seconds | Same |
| Calibration | Automatic, no Calibration Code | Same |
| Test stripactive reagent | Glucose Oxidase | Same |
| Quality Control 3 levels | Same | |
| Linearity | 5 levels | Same |
| Handheld | Yes | Same |
| Data storage | 1000 patient tests, 200 QC tests, 4000Operators | 400 patient, quality control,linearity, and proficiency tests |
| Barcode | Yes | No |
| Power source | Rechargeable 3.7 volt Lithium battery | 3v dc Li coin cell battery |
| OperatingTemp | 59°F - 104°F (15°C - 40°C) | 41° to 104°F (5° to 40°C) |
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Conclusion:
FDA had previously determined that the StatStrip Xpress Glucose Hospital Meter System is substantially equivalent to that of the predicate StatStrip Glucose Hospital Meter System (K070960, K152461). The expanded indication proposed in this submission was previously cleared for the predicate device (K181043). No changes have been made to the candidate device, the software, the test strips, controls or linearity solutions since the K161856 clearance therefore; there are no additional safety and efficacy concerns to the device.
The candidate device with the proposed revised labeling is substantially equivalent to the predicate StatStrip Glucose Hospital Meter System (K181043), and supports a CLIA waiver designation.
§ 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.