Nova StatSensor Creatinine Hospital Meter System

K171059 · Nova Biomedical Corporation · CGL · May 26, 2017 · Clinical Chemistry

Device Facts

• Record ID: K171059
• Device Name: Nova StatSensor Creatinine Hospital Meter System
• Applicant: Nova Biomedical Corporation
• Product Code: CGL · Clinical Chemistry
• Decision Date: May 26, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1225
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Nova StatSensor Creatinine Hospital Meter System is intended for the quantitative determination of creatinine in whole blood. The Nova StatSensor Creatinine Hospital Meter System is intended for use by healthcare professionals in a clinical setting. It is an in vitro diagnostic device intended to aid in the assessment of renal function.

Device Story

Nova StatSensor Creatinine Hospital Meter System; handheld point-of-care device for whole blood creatinine measurement. Input: whole blood sample applied to test strip. Operation: electrochemical biosensor technology; meter measures current proportional to creatinine concentration. Output: quantitative creatinine result displayed on screen. Used by healthcare professionals in clinical settings. Modifications include ergonomic housing redesign, larger display font, flat surface design, addition of mechanical test strip eject button, relocation of test strip port and barcode scanner, and keypad simplification. Device provides rapid renal function assessment to support clinical decision-making.

Clinical Evidence

Bench testing only. Verification and validation activities performed based on risk analysis to confirm that ergonomic and physical modifications did not impact device performance or fundamental scientific technology.

Technological Characteristics

Electrochemical biosensor; whole blood creatinine measurement. Physical modifications: plastic housing, flat top surface, relocated test strip port and barcode scanner, mechanical test strip eject button, simplified keypad. Connectivity: 2D barcode scanner added. System remains unchanged in fundamental scientific technology (electrochemical sensing).

Indications for Use

Indicated for healthcare professionals in clinical settings for quantitative determination of creatinine in whole blood to aid in assessment of renal function.

Regulatory Classification

Identification

A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Predicate Devices

• Nova StatSensor Creatinine Hospital Meter (K070068)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 26, 2017

NOVA BIOMEDICAL CORPORATION PAUL MACDONALD SENIOR DIRECTOR OF REGULATORY AFFAIRS 200 PROSPECT STREET WALTHAM MA 02454

Re: K171059

Trade/Device Name: Nova StatSensor Creatinine Hospital Meter System Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: II Product Code: CGL Dated: April 26, 2017 Received: April 27, 2017

Dear Paul MacDonald:

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

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

510(k) Number (if known) K171059

#### Device Name

Nova StatSensor Creatinine Hospital Meter System

### Indications for Use (Describe)

The Nova StatSensor Creatinine Hospital Meter System consists of the StatSensor Creatinine Hospital Meter and the Stat-Sensor Creatinine Test Strips. The Nova StatSensor Creatinine Hospital Meter System is intended for in vitro diagnostic use by healthcare professionals and for Point-Of-Care usage for the quantitative measurement of creatinine in capillary. venous, and arterial whole blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis. Not for use in neonates.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|------------------|
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter |

er Use (21 CFR 801 Subpart C)

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

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# 510(k) Summary

| 510(K) Owner: | Nova Biomedical Corporation |
|----------------------|---------------------------------------|
| Registration Number: | 1219029 |
| Address: | 200 Prospect St.<br>Waltham, MA 02454 |
| Phone: | 781-894-0800 |
| Fax Number: | 784-891-4806 |
| Contact Person: | Adam Heroux |
| Date Prepared: | May 26, 2017 |

Proprietary Name: Nova StatSensor Creatinine Hospital Meter System

Common or Usual Name: Electrode, Ion Based, Enzymatic, Creatinine

## Device Classification:

| Classification Names: | Class No. | Reg. No. | Class | Review Panel |
|------------------------|-----------|----------|-------|--------------------|
| Creatinine test system | CGL(75) | 862.1225 | II | Clinical Chemistry |

## Product Codes: CGL, Electrode, Ion Based, Enzymatic, Creatinine

## Predicate Device: K070068 Nova StatSensor Creatinine Hospital Meter

## Device Description:

The Nova StatSensor Creatinine Hospital Meter System consists of a hand held meter, test strips, control solutions, and linearity solutions. The Nova StatSensor Creatinine Hospital Meter System is a hand-held, battery-powered, in vitro diagnostic laboratory instrument that works in conjunction with Nova Biomedical creatinine electrochemical test strips to measure creatinine in a whole blood sample, a Quality Control (QC) solution, linearity, or proficiency solutions. In addition to measuring creatinine, the meter stores patient test data, QC test data, and other information relating to patient sample, operator, reagents, and the meter. A user interface provides a self-prompting environment via a color LCD. The Charging Station recharges the batteries of the meter.

## Mechanism of Action:

A test strip is inserted into the meter, and the sample is applied to the sample entry end of the strip. The test strip contains a reaction layer that contains creatinine amidohydrolase, creatinine amidinohydrolase and sarcosine oxidase that reacts with the test sample. When enough sample has been added to the test strip (sample is drawn into strip though capillary action) the meter begins its analysis. A digital readout is displayed on the meter in 30 seconds.

## Test Strips:

The test strips contain a reaction layer that contains creatinine amidohydrolase, creatinine amidinohydrolase and sarcosine oxidase. The test strip is touched to a drop of blood to initiate the test process. The test strip is designed such that when a drop of blood is touched to the end of the test strip, the blood is drawn into the reaction space via capillary action. A simple one-step process provides a blood creatinine result. Test strips are sold in vials of 25 strips.

The Nova StatSensor Creatinine Test Strips that are intended for use with the StatSensor Creatinine Hospital Meter are identical in form, fit, function and packaging, to the Nova StatSensor Creatinine Test Strips previously cleared for use with the Nova StatSensor Creatinine Hospital Meter System (K070088).

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No changes have been made to Nova StatSensor Creatinine Test Strips and they are not a subject of this submission.

# Control and Linearity Solutions:

The control solutions contain aqueous assayed solutions, creatining creatinine, preservative, viscosityadjusting agent, 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 are offered for sale separately from the meter.

The linearity solutions contain creatinine, viscosity agent, preservatives and other non-reactive ingredients (dye). They contain no products of human origin. These solutions are offered to users to verify the performance of the system. There are five levels of linearity solutions (Level 1, Level 3, Level 3, Level 3, Level 3, Level 4. Level 5). These solutions are offered for sale separately from the meter.

The Nova StatSensor Creatinine Control and Linearity Solutions that are intended for use with the StatSensor Creatinine Hospital Meter are identical in formulation and packaging, to the Control and Linearity Solutions originally cleared for use with the Nova StatSensor Creatinine Hospital Meter System (K070068). No changes have been made to Nova StatSensor Creatinine Control and Linearity Solutions and they are not a subject of this submission.

# Docking/Charging 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 for charging and a slot for an extra battery to be charged. 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. Replacement batteries are offered separately.

# Intended Use:

The Nova StatSensor Creatinine Hospital Meter System consists of the StatSensor Creatinine Hospital Meter and the StatSensor Creatinine Test Strips. The Nova StatSensor Creatinine Hospital Meter System is intended for in vitro diagnostic use by healthcare professionals and for Point-Of-Care usage for the quantitative measurement of capillary, venous, and arterial whole blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis. Not for use in neonates.

# Summary of the Technological Characteristics:

The Nova StatSensor Creatinine Hospital Meter System that is the subject of this submission uses the exact same technology, functionality, analytical and operational performance characteristics, as the predicate. The Main CPU and the Primary Strip Board Electronics are identical in both the meters. The only difference is the change in ergonomic design.

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| Characteristic | Predicate: Nova StatSensor Creatinine Hospital<br>Meter (K070068) | Proposed: Nova<br>StatSensor<br>Creatinine Hospital<br>Meter |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Intended Use | Is intended for in vitro diagnostic use by healthcare<br>professionals and for Point- Of-Care usage for the<br>quantitative measurement of creatinine in capillary,<br>venous, and arterial whole blood. Creatinine<br>measurements are used in the diagnosis and treatment<br>of renal diseases and in monitoring renal dialysis. Not for<br>use in neonates. | Same as Predicate |
| Measuring Range | 0.30 - 12.0 mg/dL or 27-1056 µmol/L | Same as Predicate |
| Acceptable Samples | Whole blood: Capillary, Arterial, Venous | Same as Predicate |
| Measuring<br>Technology | Enzyme, Amperometric | Same as Predicate |
| Operating Principle | Electrochemical biosensor test strip | Same as Predicate |
| Analysis Time | 30 seconds | Same as Predicate |
| Sample Volume | 1.2 µL | 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 |
| Docking/Charging<br>Station | Desk mount | Same as Predicate |
| Meter Memory | 1000 patient tests, 200 QC tests, 4000 Operators | Same as Predicate |
| Power source | 3.7V Li Polymer battery (Rechargeable/Replaceable) | Same as Predicate |
| Controls: | Liquid, 3 levels | Same as Predicate |
| Linearity Solutions | Liquid, 5 levels | Same as Predicate |
| Test Strips -<br>Active reagent: | creatinine amidohydrolase, creatine amidinohydrolase<br>and sarcosine oxidase | Same as Predicate |
| Screen Display | Small Font Size | Large Font Size |
| Keypad | Hard buttons | Soft Buttons |
| Dimensions | Height:153 mm (6.0 in)<br>Width: 82.5 mm (3.25 in)<br>Depth 46 mm (1.8 in) | Height: 146 mm (5.8<br>in)<br>Width:79 mm (3.1<br>in)<br>Depth:30 mm (1.18<br>in) |
| Weight | 360 grams (0.8 lb) | 220 g (0.49 lb) |
| Bar code scanner | Bottom of the Meter (1D: Symbol 965, 2D: Symbol<br>SE4400, 2D: Symbol SE4500) | Top of the Meter<br>(2D: Opticon<br>MDI3100) |
| Housing Material | Aluminum | Lighter Plastic |
| Location of Strip Port | Top of Meter | Bottom of the Meter |

Table 1: Comparison of Predicate and Proposed Devices