(87 days)
No
The document describes a standard glucose meter and test strip system. There is no mention of AI, ML, or any features that would suggest the use of such technologies for data analysis, prediction, or decision-making beyond basic measurement and storage.
No
The device is an in vitro diagnostic device used for quantitative determination of glucose, not for treating or preventing disease.
Yes
This device is explicitly stated as an "in vitro diagnostic" device in the "Intended Use / Indications for Use" and "Device Description" sections.
No
The device description clearly states it is a "hand-held, battery-powered, in vitro diagnostic laboratory instrument" and works in conjunction with "electrochemical test strips," indicating it is a hardware device with integrated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the system is intended for "point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose..."
- Device Description: The "Device Description" also refers to the meter as a "in vitro diagnostic laboratory instrument".
- Function: The device measures glucose in biological specimens (blood), which is a core function of an in vitro diagnostic device.
- Components: The system includes test strips and control solutions, which are typical components of an IVD system used for testing biological samples outside of the body.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to perform tests on samples such as blood, urine, or tissues to detect diseases or other conditions. This description perfectly aligns with the function and intended use of the StatStrip Xpress 2 Glucose Hospital Meter System.
N/A
Intended Use / Indications for Use
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 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.
Product codes
PZI
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 K163490.
Meter:
The StatStrip Xpress 2 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, a Quality Control (QC) solution, 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 2 Glucose Hospital Meter System. No changes have been made to the form, fit, function or packaging of StatStrip Glucose Hospital Meter Test Strips since K152986 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 2 Glucose Hospital Meter and the Glucose Test Strips are working properly as a system.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 13, 2018
Nova Biomedical Corporation Khushboo Surendran 200 Prospect Street Waltham, MA 02454
Re: K182549
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: 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
1
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 (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 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
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) K182549
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 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
510(k) Number: K182549
| 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 2 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, 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 K163490.
Meter:
The StatStrip Xpress 2 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, a Quality Control (QC) solution, 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 2 Glucose Hospital Meter System. No changes have been made to the form, fit, function or packaging of StatStrip Glucose Hospital Meter Test Strips since K152986 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 2 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 K152986 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 2 Glucose Hospital Meter. No changes have been made to the form, fit, function of the Nova StatStrip Glucose Linearity Solution since K152986 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 2 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 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 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 2 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).
No change is being made to the candidate device. 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 Meter
System | Candidate Device
StatStrip Xpress 2 Glucose Hospital Meter
System |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
throughout all hospital and all professional
healthcare settings, including patients
receiving intensive medical interven-
tion/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 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
throughout all hospital and all professional
healthcare settings, including patients
receiving intensive medical interven-
tion/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. |
| Operating
Principle | Electrochemical biosensor | Same |
| Measuring
Technology | Enzyme, Amperometric Glucose Enzyme
( Aspergillus sp., >1.0 IU) | Same |
| Sample type | Capillary whole blood (finger stick), venous
whole blood, arterial whole blood, neonatal
heel stick, and neonatal arterial whole blood
samples | Same |
| Sample size | 1.2 $μ$ L | Same |
| Sample
application | Test strip capillary draw | Same |
| Measuring
range | 10-600 mg/dL | Same |
| Hematocrit
range | 20-65% | Same |
| Item | Predicate Device (K181043)
StatStrip Glucose Hospital Meter
System | Candidate Device
StatStrip Xpress 2 Glucose Hospital Meter
System |
| Reported
output | mg/dL | Same |
| Time to Result | ~ 6 seconds | Same |
| Calibration | Automatic, no Calibration Code | Same |
| Test strip
active reagent | Glucose Oxidase | Same |
| Quality Control | 3 levels | Same |
| Linearity | 5 levels | Same |
| Handheld | Yes | Same |
| Data storage | 1000 patient tests, 200 QC tests, 4000
Operators | 400 patient, quality control,
linearity, and proficiency tests |
| Barcode | Yes | No |
| Power source | Rechargeable 3.7 volt Lithium battery | 2 AAA Batteries |
| Operating
Temp | 59°F - 104°F (15°C - 40°C) | 41° to 104°F (5° to 40°C) |
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Conclusion:
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 K163490 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.