The StatStrip Xpress 2 Glucose Hospital Meter System is intended for point-of-care, in vitro diagnosic, 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 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.

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.

Device Description

The Nova Biomedical StatStrip Xpress 2 Glucose Hospital Meter System consists of a hand held meter, test strips, control solutions, and linearity solutions. The test strip contains a reagent (glucose oxidase) that reacts with the glucose in the test sample is applied to the test strip, which is then analyzed in the meter. The reagent test strip contains glucose oxidase and glucose dehydrogenase, which reacts with the glucose in the test sample.

A test strip is inserted into the meter, and the sample is applied to the sample entry end of the strip. When enough sample has been added to the strip (sample is drawn into strip though capillary action) the meter begins its analysis. A digital readout is displayed on the meter in 6 seconds. The system is designed for hospital point of care (POC) use including physicians' office labs.

AI/ML Overview

The provided document discusses the StatStrip Xpress 2 Glucose Hospital Meter System, a point-of-care, in vitro diagnostic device for quantitative determination of glucose. The document is a 510(k) summary and indicates that the proposed device is substantially equivalent to a predicate device (K152986). The only change mentioned is the modification of the lower limit of the operating temperature range from 15°C to 5°C.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific acceptance criteria (e.g., accuracy percentages, bias limits) for the glucose meter's performance. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "Reported Device Performance" is implicitly that the device performs equivalently to the predicate device across all characteristics, with the exception of the broadened operating temperature range, which is stated not to adversely affect safety or efficacy.

The document provides a comparison table (Table 1) between the predicate and proposed devices, which details various characteristics:

Characteristic	Predicate: StatStrip Xpress 2 Glucose Hospital Meter System (K152986)	Proposed: StatStrip Xpress 2 Glucose Hospital Meter System	Performance Claim / Status
Intended Use	(Detailed description provided in the document)	Same as Predicate	Equivalent
Measuring Range	10-600 mg/dL	Same as Predicate	Equivalent
Hematocrit Range	20-70 %	Same as Predicate	Equivalent
Operating Principle	Electrochemical biosensor	Same as Predicate	Equivalent
Operating Temperature Range	59-104°F (15-40°C)	41-104°F (5-40°C)	Modified/Improved
Sample type	(Detailed description provided in the document)	Same as Predicate	Equivalent
Sample size	1.2 uL	Same as Predicate	Equivalent
Sample application	Test strip capillary draw	Same as Predicate	Equivalent
Handheld meter?	YES	Same as Predicate	Equivalent
Meter Calibration	Automatic, no Calibration Code	Same as Predicate	Equivalent
Data storage	400 test results	Same as Predicate	Equivalent
Test Time	6 sec	Same as Predicate	Equivalent
Weight	2.77 oz.	Same as Predicate	Equivalent
Bar code scanner	None	Same as Predicate	Equivalent
Power source	Two AAA Batteries	Same as Predicate	Equivalent
Controls:	Liquid, 3 levels	Same as Predicate	Equivalent
Linearity Solutions	Liquid, 5 levels	Same as Predicate	Equivalent
Test Strips - Active reagent:	Glucose Oxidase	Same as Predicate	Equivalent
Screen Type	Non segmented Color Display	Same as Predicate	Equivalent
Location of Strip Port	Bottom of Meter	Same as Predicate	Equivalent

The document states, "The modification of the lower limit of the operating temperature range from 15°C to 5°C does not adversely affect the safety or efficacy of the device." This statement implies that testing was conducted to prove the device's performance remains acceptable within this extended temperature range, but the specific data or acceptance criteria used for this proof are not detailed in the provided text.

2. Sample Size Used for the Test Set and the Data Provenance

The provided document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective) for the studies supporting the device's performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not available in the provided document. The document pertains to a medical device (glucose meter) rather than an AI or image-based diagnostic system that would typically require expert ground truth labeling.

4. Adjudication Method for the Test Set

This information is not available in the provided document. As mentioned above, this is not typically applicable for a glucose meter's performance evaluation in the same way it would be for an AI diagnostic.

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

This information is not applicable to the StatStrip Xpress 2 Glucose Hospital Meter System, as it is a standalone diagnostic device and not an AI-assisted interpretation tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself, the StatStrip Xpress 2 Glucose Hospital Meter System, operates in a standalone manner to provide glucose measurements. The 510(k) summary implicitly covers the standalone performance of the device without human interpretation of the underlying signal, as it provides a direct digital readout. However, this is distinct from "algorithm only performance" in the context of an AI-driven system that outputs a diagnostic result for human review.

7. The Type of Ground Truth Used

For a glucose meter, the "ground truth" for accuracy studies would typically be established by comparing the device's readings to a laboratory reference method (e.g., a central lab analyzer using a hexokinase or glucose oxidase method) known for its high accuracy and precision. The document does not explicitly state the type of ground truth used, but this is the standard practice for such devices. It's not expert consensus, pathology, or outcomes data in this context.

8. The Sample Size for the Training Set

This information is not available in the provided document. As a traditional medical device (not an AI/machine learning product for which a "training set" is typically discussed), the concept of a training set for an algorithm as a distinct entity is not explicitly mentioned. Development and validation would involve various studies, but not in the framework of training an AI model.

9. How the Ground Truth for the Training Set Was Established

This information is not available in the provided document. See the explanation for point 8.

Summary

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March 1, 2019

Nova Biomedical Corporation Paul MacDonald Senior Director of Regulatory Affairs 200 Prospect Street Waltham, MA 02454

Re: K163490

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 9, 2016 Received: December 12, 2016

Dear Paul MacDonald:

This letter corrects our substantially equivalent letter of January 6, 2017.

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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.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 applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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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:	December 9, 2016

Proprietary Name: StatStrip Xpress 2 Glucose Hospital Meter System

Common or Usual Name: Blood Glucose Meter

Classification Name:

Classification Names:	Class No.	Reg. No.	Class
Glucose Oxidase	75CGA	862.1345	II

Product Codes: CGA, Glucose Oxidase, Glucose

Predicate Device: K152986 - StatStrip Xpress 2 Glucose Hospital Meter System

Device Description:

Test Strips:

The StatStrip Glucose Test Strip is designed with an electrode that measures Glucose levels. 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 end of 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 50 strips.

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.

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The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick.

It is not intended for use with neonate cord blood specimens.

It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia.

Summary of the Technological Characteristics:

The StatStrip Xpress 2 Glucose Hospital Meter System is substantially equivalent to the predicate device. The modification of the lower limit of the operating temperature range from 15°C to 5°C does not adversely affect the safety or efficacy of the device.

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Characteristic	Predicate: StatStrip Xpress 2 Glucose Hospital MeterSystem (K152986)	Proposed: StatStripXpress 2 GlucoseHospital Meter System
Intended Use	The StatStrip Xpress 2 Glucose Hospital Meter System isintended for point-of-care, in vitro diagnostic, multiple-patientuse for the quantitative determination of glucose in capillaryfinger stick, venous whole blood, arterial whole blood, neonatearterial whole blood and neonate heel stick specimens.The StatStrip Xpress 2 Glucose Hospital Meter System is alsointended for use in the quantitative determination of glucose invenous whole blood, arterial whole blood, neonatal heel stickand neonatal arterial samples throughout all hospital and allprofessional healthcare settings.The system should only be used with single-use, auto-disablinglancing devices when performing a capillary finger stick orneonate heel stick.It is not intended for use with neonate cord blood specimens.It is not intended for the screening or diagnosis of diabetesmellitus but is indicated for use in determining dysglycemia.	Same as Predicate
Measuring Range	10-600 mg/dL	Same as Predicate
Hematocrit Range	20-70 %	Same as Predicate
Operating Principle	Electrochemical biosensor	Same as Predicate
OperatingTemperature Range	59-104°F (15-40°C)	41-104°F (5-40°C)
Sample type	Capillary whole blood (finger stick), venous whole blood, arterialwhole blood, neonate heel stick, and neonate arterial wholeblood specimens.Venous whole blood, arterial whole blood, neonatal heel stick,and neonatal arterial whole blood samples throughout allhospital and all professional healthcare settings.	Same as Predicate
Sample size	1.2 uL	Same as Predicate
Sample application	Test strip capillary draw	Same as Predicate
Handheld meter?	YES	Same as Predicate
Meter Calibration	Automatic, no Calibration Code	Same as Predicate
Data storage	400 test results	Same as Predicate
Test Time	6 sec	Same as Predicate
Weight	2.77 oz.	Same as Predicate
Bar code scanner	None	Same as Predicate
Power source	Two AAA Batteries	Same as Predicate
Controls:	Liquid, 3 levels	Same as Predicate
Linearity Solutions	Liquid, 5 levels	Same as Predicate
Test Strips -Active reagent:	Glucose Oxidase	Same as Predicate
Screen Type	Non segmented Color Display	Same as Predicate
Location of Strip Port	Bottom of Meter	Same as Predicate

Table 1: Comparison of Predicate and Proposed Devices

Regulation Number and Section

§ 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.