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.

Device Description

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.

The StatStrip Glucose Hospital Meter Test Strips are intended for use with the StatStrip Xpress 2 Glucose Hospital Meter System.

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.

The Nova StatStrip Glucose Linearity Solutions are used to check the linearity of the Nova StatStrip Xpress 2 Glucose Hospital Meter.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the StatStrip Xpress 2 Glucose Hospital Meter System. It states that the purpose of this submission is to change the labeling to include the use of capillary whole blood specimens in all hospital and professional healthcare settings, including for patients receiving intensive medical intervention/therapy. Crucially, it highlights that this expanded indication was previously cleared for the predicate device, StatStrip Glucose Hospital Meter System (K181043), and no changes have been made to the candidate device itself, the test strips, controls, or linearity solutions since its prior clearance (K163490).

Therefore, the submission is not focused on proving the device meets new acceptance criteria through a new study, but rather on demonstrating substantial equivalence to a predicate device that already had this expanded indication cleared. The document implies that the device inherently meets these criteria because it is identical to a previously cleared device for the expanded use.

Given this context, if we were to infer "acceptance criteria" and "study" from the provided text, it would be based on the original clearance of the predicate device (K181043) for the expanded indication, or the original clearance of the candidate device (K163490) for its initial indications. However, the current document does not detail those studies.

Therefore, many of the requested items (sample size, data provenance, expert ad-judgement, MRMC studies, standalone performance, training set details) are not described in the provided text because this 510(k) relies on the substantial equivalence principle, not on a new study for the device itself to prove the expanded indication.

Here's a breakdown of what can be inferred or directly stated from the text, and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria or performance data from a new study specific to this K182549 submission. It states: "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." This implies that the performance data for this expanded indication was deemed acceptable in the predicate device's clearance.

However, the "Comparison of Predicate and Candidate devices" table (Page 5-6) lists technological characteristics that could act as implied performance specifications or features if a study were to be conducted. Since no new study is described, this is a comparison of design, not performance data from a new study.

Item	Predicate Device (K181043) StatStrip Glucose Hospital Meter System	Candidate Device StatStrip Xpress 2 Glucose Hospital Meter System	Implied Acceptance Criteria (based on device specs)	Reported Device Performance (as stated in document, no new study performance data presented)
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 throughout all hospital and all professional healthcare settings, including patients receiving intensive medical intervention/therapy.	Same	Device successfully determines glucose in specified samples and settings.	Stated to be the same and previously cleared. No new performance data provided in this document.
Operating Principle	Electrochemical biosensor	Same	Operates as an electrochemical biosensor.	Achieved (by identity to predicate).
Measuring Technology	Enzyme, Amperometric Glucose Enzyme (Aspergillus sp., >1.0 IU)	Same	Uses specified enzyme and amperometric technology.	Achieved (by identity to predicate).
Sample type	Capillary whole blood (finger stick), venous whole blood, arterial whole blood, neonatal heel stick, and neonatal arterial whole blood samples	Same	Compatible with specified sample types.	Achieved (by identity to predicate).
Sample size	1.2 $μ$ L	Same	Requires 1.2 $μ$ L sample.	Achieved (by identity to predicate).
Measuring range	10-600 mg/dL	Same	Accurately measures within 10-600 mg/dL.	Achieved (by identity to predicate).
Hematocrit range	20-65%	Same	Functions correctly within 20-65% hematocrit.	Achieved (by identity to predicate).
Time to Result	~ 6 seconds	Same	Produces result in ~6 seconds.	Achieved (by identity to predicate).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not specified. The document does not describe a new study or test set for this 510(k) submission. It relies on the previous clearance of the predicate device for the expanded indication.

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/Not specified. Since no new human-expert based ground truth for a test set is described, this information is not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not specified. No new test set or adjudication process is described.

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 device is a blood glucose meter, not an AI imaging analysis system that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, implicitly. A blood glucose meter operates as a standalone device, providing a quantitative result without human "interpretation" of a complex output. The "performance" of such a device is typically assessed as an algorithm (meter software) reading a biochemically induced electrical signal. However, the document does not describe the specific standalone performance study from this submission, but rather refers to prior clearances.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For a blood glucose meter, the ground truth would typically be established by a reference method (e.g., a laboratory-grade glucose analyzer, often using enzymatic or hexokinase methods) that is highly accurate and precise. This is implied by the nature of glucose measurement, but not explicitly stated in this document for this submission.

8. The sample size for the training set

Not specified. No details on training sets are provided, as this is not a de novo AI/ML device submission. The device is based on established electrochemical biosensor technology.

9. How the ground truth for the training set was established

Not specified. (See point 8).

Summary

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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

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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.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 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 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 K163490.

Meter:

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:

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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 MeterSystem	Candidate DeviceStatStrip Xpress 2 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 2 Glucose HospitalMeter System is intended for point-of-care,in vitro diagnostic, multiple-patient use forthe quantitative 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 $μ$ L	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 2 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	2 AAA Batteries
OperatingTemp	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.

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.