StatStrip Glucose Hospital Meter System

K232075 · Nova Biomedical Corporation · PZI · Feb 23, 2024 · Clinical Chemistry

Device Facts

• Record ID: K232075
• Device Name: StatStrip Glucose Hospital Meter System
• Applicant: Nova Biomedical Corporation
• Product Code: PZI · Clinical Chemistry
• Decision Date: Feb 23, 2024
• Decision: SESE
• Submission Type: Dual Track
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

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 neonatal 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 neonatal 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.

Device Story

Handheld point-of-care meter for quantitative glucose measurement in hospital settings; operated by healthcare professionals. Inputs: whole blood samples (capillary, venous, arterial, neonatal) applied to test strips via capillary action. Principle: electrochemical biosensor using glucose oxidase enzyme chemistry; electrons generated proportional to glucose concentration; signal converted to plasma-equivalent result. Output: digital glucose concentration displayed on meter. Modifications include relocated test strip port, wireless charging, updated user interface, increased data storage, and validated cleaning/disinfection protocols. Data management: bi-directional transfer via docking station to external systems. Benefits: rapid bedside glucose monitoring for clinical decision-making in intensive care and general hospital settings.

Clinical Evidence

No clinical trials performed. Evidence includes supplementary bench accuracy studies comparing venous whole blood results to YSI 2300 STAT Glucose and L-Lactate analyzer and predicate device. Usability study conducted with CLIA-waived users confirmed ease of use and accurate performance following design modifications. Infection control studies validated disinfection efficacy against HBV and material robustness over 10,950 cycles. Electrical safety and EMC testing confirmed compliance.

Technological Characteristics

Electrochemical biosensor; glucose oxidase enzyme chemistry. Handheld meter with 3.6V Li-Polymer battery. Connectivity: bi-directional data transfer via docking station. Software: Linux-based OS. Sterilization: N/A (disinfection validated for multiple-patient use). Compliant with EN 60601-1-2 (EMC).

Indications for Use

Indicated for quantitative glucose determination in capillary finger stick, venous, arterial, neonatal arterial, and neonatal heel stick whole blood specimens in hospital/professional settings. Not for neonate cord blood, diabetes screening/diagnosis, or Tight Glycemic Control protocols.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• StatStrip Glucose Hospital Meter System (K181043)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 23, 2024

Nova Biomedical Corporation Abhinav Kulkarni Regulatory Affairs Specialist-II 200 Prospect St. Waltham, Massachusetts 02454

# Re: K232075

Trade/Device Name: StatStrip Glucose Hospital Meter System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: PZI Dated: October 26, 2023 Received: October 26, 2023

# Dear Abhinav Kulkarni:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Paula V. Caposino -S

Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known) K232075

Device Name StatStrip Glucose Hospital Meter System

#### Indications for Use (Describe)

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 neonatal 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 neonatal 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.

The StatStrip Glucose Hospital Meter System includes the following components:

- StatStrip Glucose Hospital Meter
- StatStrip Glucose Test Strips

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
|------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
|------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|

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Image /page/4/Picture/0 description: The image shows the logo for Nova Biomedical. The logo is in blue and features the word "nova" in a stylized font on the top line. Below that, the word "biomedical" is written in a smaller, similar font. There is a registered trademark symbol next to the word "nova".

# 510(k) Summary

| 510(K) Number: | K232075 |
|----------------------|--------------------------------------------|
| 510(K) Owner: | Nova Biomedical Corporation |
| Registration Number: | 1219029 |
| Address: | 200 Prospect St.<br>Waltham, MA 02454 USA |

Contact Person: Abhinav Kulkarni Regulatory Affairs Specialist - II 781-894-0080 x 1672 (Office) [e-mail]

Secondary Contact Person: Bobby Zinck Senior Manager, Requlatory Affairs 781-894-0800 x 1705 (Office) [e-mail]

Date Prepared October 26, 2023

Proprietary Name StatStrip Glucose Hospital Meter System

Common or Usual Name

Blood Glucose Meter

#### Classification Name:

| Classification Name | Regulation # | Class | Product Code | Panel |
|------------------------------------------------------------------|--------------|-------|--------------|--------------------|
| Prescription Use Blood Glucose Meter for<br>Near-Patient Testing | 862.1345 | II | PZI | Clinical Chemistry |

#### Predicate Device

The predicate device for this submission is the StatStrip Glucose Hospital Meter System (K181043).

#### Purpose for Submission:

The StatStrip Glucose Hospital Meter System previously cleared under K060345, K063821, K132121, K150281, and K181043 is being modified to a next-generation meter platform to incorporate a new ergonomic design, and a new Operating System (OS).

#### Device Description:

StatStrip Glucose Hospital Meter System:

The StatStrip Glucose Hospital Meter System is a hand-held testing device that works in conjunction with the StatStrip Glucose Test Strips to measure glucose in a whole blood sample. Meter operation is selfprompting using an illuminated color touch-screen Graphical User Interface (GUI).

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#### StatStrip Glucose Test Strips:

The test strips contain a reaction layer that contains a glucose-enzyme (greater than 1.0 IU) and ferricyanide as a mediator. The test strip is touched to a drop of blood to initiate the test process. 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 vials of 25 strips.

#### StatStrip Glucose Control Solutions:

The control solutions are aqueous assayed solutions containing buffered D-Glucose, viscosity-adjusting agent, preservatives and other non-reactive ingredients (dye). They contain no products of human origin. There are three levels of controls, (Level 1, Level 2 and Level 3). These solutions will be offered for sale separately from the meter.

#### StatStrip Glucose Linearity Solutions:

There are 5 levels of Linearity solutions containing buffered D-Glucose, viscosity-adjusting agent, preservatives and other non-reactive ingredients (dve). They contain no products of human origin. These solutions are offered separately from the system for users to verify the performance of the system.

#### Charging (Docking) Station:

The meter charging station is a stationary accessory used to recharge the meter. The charging station has one slot for the meter to be placed and charged wirelessly. The charging station should be located central to the patient care area being served by the meter (e.g., a nursing station). The data charging station must remain plugged in to a wall outlet for power.

The system still allows the charging station to be used to transfer data from the meter to a central workstation and allow meter setup information to be downloaded from the central workstation to the meter.

#### Intended Use:

The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiplepatient 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 Glucose Hospital Meter System includes the following components:

- StatStrip Glucose Hospital Meter
- StatStrip Glucose Test Strips

#### Summary of Performance Testing:

The following testing was completed to demonstrate that the StatStrip Glucose Hospital Meter System is substantially equivalent to the predicate device.

#### ACCURACY

This study validated the performance equivalency between the StatStrip Glucose Hospital Meter System and the predicate device by measuring glucose on deidentified venous whole blood samples from consented donors.

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Three (3) StatStrip Glucose Hospital Meters and three (3) predicate devices were tested side-by-side using three (3) lots of glucose test strips. A total of hundred (100) venous whole blood samples with glucose concentrations ranging from 20-600 mg/dL were tested on all meters, and the results were compared with a reference analyzer.

The Bias or Bias% for each specimen was calculated against the reference value, and the results were also compared to the FDA Guidance for POC Device Acceptance Criteria (Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use, Guidance for Industry and Food and Drug Administration Staff, September 29, 2020).

#### Next Generation StatStrip Glucose Hospital Meter (Proposed Device) Glucose concentrations < 75 mg/dL

| Within ± 5 mg/dL | Within ± 10 mg/dL | Within ± 12 mg/dL | Within ± 15 mg/dL |
|------------------|-------------------|-------------------|-------------------|
| 33/36 (91.7%) | 36/36 (100%) | 36/36 (100%) | 36/36 (100%) |

# Current Production StatStrip Glucose Hospital Meter (Predicate Device) Glucose concentrations < 75 mg/dL

| Within ± 5 mg/dL | Within ± 10 mg/dL | Within ± 12 mg/dL | Within ± 15 mg/dL |
|------------------|-------------------|-------------------|-------------------|
| 32/36 (88.9%) | 36/36 (100%) | 36/36 (100%) | 36/36 (100%) |

# Next Generation StatStrip Glucose Hospital Meter (Proposed Device) Glucose concentrations ≥ 75 mg/dL

| Within ± 5 % | Within ± 10 % | Within ± 12 % | Within ± 15 % |
|-----------------|-----------------|----------------|----------------|
| 205/264 (77.3%) | 263/264 (99.6%) | 264/264 (100%) | 264/264 (100%) |

# Current Production StatStrip Glucose Hospital Meter (Predicate Device) Glucose concentrations ≥ 75 mg/dL

| Within ± 5 % | Within ± 10 % | Within ± 12 % | Within ± 15 % |
|-----------------|-----------------|----------------|----------------|
| 211/264 (80.7%) | 263/264 (99.6%) | 264/264 (100%) | 264/264 (100%) |

# Linear Regression Summary - Slope and Correlation Coefficient (r) Values

| Condition | Slope | Intercept | Correlation<br>Coefficient (r) |
|---------------------------------------|--------|-----------|--------------------------------|
| Proposed Device v<br>YSI | 0.9799 | 5.2357 | 0.9977 |
| Predicate Device v<br>YSI | 0.9848 | 5.2164 | 0.9984 |
| Proposed Device v<br>Predicate Device | 0.9935 | 0.3571 | 0.9978 |

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In conclusion, the results of this study demonstrated that the correlation and performance of the StatStrip Glucose Hospital Meter System is equivalent to the predicate device and the reference analyzer for glucose measurements, exhibiting good overall clinical agreement between the systems.

# METHOD COMPARISON AND PRECISION

This study was conducted to verify and validate the Method Comparison and Precision performance equivalency between the StatStrip Glucose Hospital Meter System and the predicate device.

In this study, three (3) lots of glucose test strips, five (5) StatStrip Glucose Hospital Meters and five (5) predicate devices were used. Seven (7) levels of deidentified venous whole blood samples from consented donors and five (5) levels of linearity solutions were tested on all meters in the test results were compared to whole blood glucose measured on the reference analyzer.

The Mean, SD or CV% were calculated for each linearity level and meter (n =60); the Bias or Bias% (between calculated Means for each meter type) was calculated for each venous whole blood level. In addition, linear regression curves were plotted for venous whole blood, comparing the StatStrip Glucose Hospital Meter System and the predicate device.

Precision:

| Linearity<br>Levels | N | Predicate Device | | Proposed Device | |
|---------------------|----|------------------|--------|-----------------|--------|
| | | Mean | SD/%CV | Mean | SD/%CV |
| Level 1 | 60 | 20.2 | 0.96 | 20.4 | 0.85 |
| Level 2 | 60 | 62.2 | 1.61 | 62.4 | 1.76 |
| Level 3 | 60 | 116.4 | 2.43 | 116 | 2.58 |
| Level 4 | 60 | 300.8 | 2.71 | 301.5 | 2.40 |
| Level 5 | 60 | 505.6 | 3.04 | 508.1 | 3.78 |

# Linearity Solutions/Samples

# Venous Whole Blood Samples

| YSI | | Predicate Device | | Proposed Device | |
|------|----|------------------|--------|-----------------|--------|
| Mean | N | Mean | SD/%CV | Mean | SD/%CV |
| 49 | 60 | 49.7 | 2.75 | 49.1 | 2.32 |
| 88 | 60 | 90.1 | 2.79 | 88.8 | 3.36 |
| 156 | 60 | 154.4 | 3.66 | 156.1 | 3.23 |
| 263 | 60 | 263.9 | 3.05 | 265.9 | 3.09 |
| 371 | 60 | 364.0 | 3.04 | 363.0 | 2.69 |
| 458 | 60 | 456.5 | 2.80 | 453.0 | 2.01 |
| 531 | 60 | 535.9 | 2.37 | 532.1 | 1.73 |

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# Method Comparison/Accuracy:

| YSI | Lot 0322311249 | | | Lot 0322325249 | | | Lot 0322346249 | | |
|---------|----------------|-----------|--------|----------------|-----------|-------|----------------|-----------|--------|
| Blood | Proposed | Predicate | Bias*/ | Proposed | Predicate | Bias% | Proposed | Predicate | Bias*/ |
| Glucose | Device | Device | Bias% | Device | Device | | Device | Device | Bias% |
| (mg/dL) | Mean | Mean | | Mean | Mean | | Mean | Mean | |
| 49 | 49.4 | 50.5 | -1.2* | 49.5 | 47.8 | -0.3* | 50.5 | 50.9 | -0.4* |
| 88 | 89.2 | 90.8 | -1.6* | 89.0 | 90.3 | -1.3* | 88.3 | 89.4 | -1.1* |
| 156 | 154.2 | 152.6 | 1.0% | 156.1 | 153.8 | 1.5% | 157.9 | 157.0 | 0.6% |
| 263 | 264.0 | 260.3 | 1.4% | 266.1 | 263.7 | 0.9% | 267.7 | 267.6 | 0.0% |
| 371 | 363.0 | 356.4 | 1.9% | 362.4 | 366.0 | -1.0% | 363.6 | 369.7 | -1.7% |
| 458 | 453.0 | 456.4 | -0.7% | 450.5 | 453.4 | -0.6% | 455.6 | 459.6 | -0.9% |
| 531 | 533.5 | 536.5 | -0.5% | 529.9 | 533.9 | -0.7% | 533.1 | 537.4 | -0.8% |

# Accuracy Data Summary (Venous Whole Blood Samples)

# Linear Regression:

# Linear Regression Summary - Slope and Correlation Coefficient (r) Values

| Condition | Slope | Intercept | Correlation<br>Coefficient (r) |
|---------------------------------------|--------|-----------|--------------------------------|
| Predicate Device v<br>YSI | 0.9996 | 0.0936 | 0.9985 |
| Proposed Device v<br>YSI | 0.9922 | 0.9900 | 0.9989 |
| Proposed Device v<br>Predicate Device | 0.9902 | 1.755 | 0.9980 |

In conclusion, all the measurements passed the acceptance criteria, and the testing results confirmed that the performance of the StatStrip Glucose Hospital Meter System is substantially equivalent to that of the predicate device.

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# Substantial Equivalence Information:

The StatStrip Glucose Hospital Meter System (K232075) is substantially equivalent in terms of intended use/indications for use, fundamental scientific technology, principle of operation, reagents used,
predicate device.

The table below provides a comparison between the currently released (predicate device) and the proposed device.

| Characteristic | Predicate: StatStrip Glucose Hospital<br>Meter System (K181043) | Proposed: StatStrip Glucose Hospital<br>Meter System (K232075) |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Intended Use | The StatStrip Glucose Hospital Meter System is<br>intended for point-of-care, in vitro diagnostic,<br>multiple-patient use for the quantitative<br>determination of glucose in capillary finger stick,<br>venous whole blood, arterial whole blood, neonate<br>arterial whole blood, and neonate heel stick<br>specimens throughout all hospital and all<br>professional healthcare settings, including critical<br>care settings.<br>The system should only be used with single-use,<br>auto-disabling lancing devices when performing a<br>capillary finger stick or neonate heel stick.<br>It is not intended for use with neonate cord blood<br>specimens.<br>It is not intended for the screening or diagnosis of<br>diabetes mellitus but is indicated for use in<br>determining dysglycemia. | Same as Predicate |
| Environment Used | Hospital and all Professional healthcare settings,<br>including critical care; Point-of-care settings | Same as Predicate |
| Measuring Range | 10 - 600 mg/dL (or) 0.6 - 33.3 mmol/L | Same as Predicate |
| Hematocrit Range | 20-70%* | Same as Predicate |
| Operating Principle | Electrochemical biosensor | Same as Predicate |
| Sample Type | Capillary whole blood (finger stick),<br>venous whole blood, arterial whole blood,<br>neonatal arterial whole blood samples, neonatal<br>heel stick throughout all hospital and all<br>professional healthcare settings, including critical<br>care settings | Same as Predicate |
| Sample Size | 1.2 μL | Same as Predicate |
| Sample Application | Test Strip capillary draw | Same as Predicate |
| Overall Design | Handheld Meter | Same as Predicate |
| Meter Calibration | Automatic, no calibration code | Same as Predicate |
| Data Storage | 1500 patient tests, 4000 operator records | 1500 patient tests, 8000 operator records<br>200 QC test results |
| Test Time | 6 seconds | Same as Predicate |
| Test Strips - Active | Glucose oxidase | Same as Predicate |
| Characteristic | Predicate: StatStrip Glucose Hospital<br>Meter System (K181043) | Proposed: StatStrip Glucose Hospital<br>Meter System (K232075) |
| Measurement<br>Technology | Enzyme, Amperometric Glucose Enzyme<br>(Aspergillus sp., >1.0 IU) | Same as Predicate |
| Quality Controls | Liquid, 3 levels | Same as Predicate |
| Linearity | Liquid, 5 levels | Same as Predicate |
| Docking Station | Yes | Same as Predicate |
| Wireless Charging | No | Yes |
| Battery | Yes, 3.7V Li Polymer Battery (rechargeable)<br>1250 mAh | Yes, 3.6V Li Polymer Battery (rechargeable)<br>2200 mAh |
| Barcode Scanner | Yes | Same as Predicate |
| Wi-Fi Connectivity | Yes (802.11 for wireless communication) | Same as Predicate |
| Software Operating<br>System (OS) | Windows CE | Linux |
| Dimensions | 146 mm (5.8 in) x 79 mm (3.1 in)<br>x 30 mm (1.18 in) | 158 mm (6.23 in) x 77 mm (3.04 in)<br>x 28 mm (1.11 in) |
| Weight | 220 grams (0.49 lb) | 215 grams (0.47 Ib) |
| Temperature range | 59°F - 104°F (15°C - 40°C) | Same as Predicate |
| Altitude | Up to 15,000 feet | Same as Predicate |
| Relative Humidity | Up to 90% (non-condensing) | Same as Predicate |

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*The Hematocrit Range for the StatStrip Glucose Hospital Meter System was established as 20-70% in K132121 and K181043 with the FDA.

# Conclusion

The performance testing study data results confirmed that the StatStrip Glucose Hospital Meter System (K232075) is safe and effective for its intended purpose. The StatStrip Glucose Hospital Meter System is substantially equivalent to the predicate StatStrip Glucose Hospital Meter System (K181043).