Stat Profile Prime Plus Analyzer System

K180428 · Nova Biomedical Corporation · JGS · Aug 15, 2018 · Clinical Chemistry

Device Facts

• Record ID: K180428
• Device Name: Stat Profile Prime Plus Analyzer System
• Applicant: Nova Biomedical Corporation
• Product Code: JGS · Clinical Chemistry
• Decision Date: Aug 15, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1665
• Device Class: Class 2

Intended Use

The Stat Profile® Prime Plus Analyzer System is intended for use by healthcare professionals in clinical laboratory settings for the quantitative determination of sodium, potassium, chloride, ionized calcium, and ionized magnesium in heparinized arterial and venous whole blood. Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison’s disease, dehydration, or diseases involving electrolyte imbalance. Potassium measurements are used in the diagnosis and treatment of disease conditions characterized by low or high potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. Ionized calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). Ionized magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium).

Device Story

Stat Profile Prime Plus Analyzer System; clinical laboratory use; quantitative electrolyte analysis. Inputs: heparinized arterial/venous whole blood (135 μL). Principle: ion-selective electrode (ISE) potentiometry; potential proportional to logarithm of ionic activity (Nernst equation). Output: concentration values for Na, K, Cl, iCa, iMg (plus optional CO-Oximeter parameters depending on sensor card). Operation: barcode scan or manual touchscreen entry; automated processing via sensor cartridges/calibrator packs. Healthcare providers use output for diagnosis/treatment of electrolyte/metabolic disorders. Benefits: rapid, accurate electrolyte monitoring in clinical settings.

Clinical Evidence

Bench testing only. Precision/reproducibility evaluated using QC materials and whole blood (n=20 replicates; 20-day run-to-run studies). Linearity confirmed across claimed ranges (r > 0.99). Analytical specificity tested against common interferents; interference thresholds defined. Method comparison against predicate (n=214-222 samples) showed high correlation (slopes 0.997-1.015; r=0.975-0.999).

Technological Characteristics

Ion-selective electrode (ISE) sensing; potentiometric measurement. 10.1" WXGA 1280x800 color touch screen. Analyte ranges: Na (80-200 mmol/L), K (1.0-20.0 mmol/L), Cl (50-200 mmol/L), iCa (0.1-2.7 mmol/L), iMg (0.1-1.5 mmol/L). Traceable to NIST SRM standards. Complies with IEC 61010-1 and IEC 61010-2-101.

Indications for Use

Indicated for healthcare professionals in clinical laboratory settings for quantitative measurement of sodium, potassium, chloride, ionized calcium, and ionized magnesium in heparinized arterial and venous whole blood.

Regulatory Classification

Identification

A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

Predicate Devices

• Stat Profile pHOx Ultra Analyzer System (k110648)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.

August 15, 2018

Nova Biomedical Corporation Cesidio Tempesta Sr. Regulatory Affairs Specialist 200 Prospect St. Waltham, MA 02454

Re: K180428

Trade/Device Name: Stat Profile Prime® Plus Analyzer System Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium test system Regulatory Class: Class II Product Code: JGS, CEM, CGZ, JFP, CFA Dated: July 2, 2018 Received: July 3, 2018

Dear Cesidio Tempesta:

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

{1}------------------------------------------------

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.html; 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 medical devices and radiation-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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

K180428

#### Device Name

#### Stat Profile® Prime Plus Analyzer System

#### Indications for Use (Describe)

The Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings for quantitative determination of sodium, chloride, ionized calcium, and ionized magnesium in heparinized arterial and venous whole blood.

| Sodium (Na) | measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus,<br>adrenal hypertension, Addison's disease, dehydration, or diseases involving electrolyte imbalance. |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Potassium (K) | measurements are used in the diagnosis and treatment of disease conditions characterized by low<br>or high potassium levels. |
| Chloride (CI) | measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders<br>such as cystic fibrosis and diabetic acidosis. |
| lonized Calcium (iCa) | measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone<br>diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). |
| lonized Magnesium (iMg) | measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low<br>levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium). |

| 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:

Department of Health and Human Services

Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) Summary K180428

| 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: | Cesidio Tempesta, Regulatory Affairs Specialist |
| Date Prepared: | August 9, 2018 |

Proprietary Name: Stat Profile Prime Plus Analyzer System

#### Common or Usual Name: Blood Gas Analyzer

#### Classification Name: Multiple

| Classification Name | Regulation # | Class | Product<br>Code | Panel |
|-----------------------|--------------|----------|-----------------|-------------------|
| Sodium Test System | 862.1665 | II | JGS | Chemistry<br>(75) |
| Potassium Test System | 862.1600 | II | CEM | |
| Chloride Test System | 862.1170 | II | CGZ | |
| Calcium Test System | 862.1145 | II | JFP | |
| Magnesium Test System | 862.1495 | I, | CFA | |
| | | reserved | | |

Predicate Device: K110648 - Stat Profile pHOx Ultra Analyzer System

#### Device Description:

The Stat Profile Prime Plus Analyzer System is designed to be a low cost, low maintenance analyzer for the hospital laboratory setting. It consists of the analyzer, sensor cartridges, and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets).

The system architecture and user interface for this proposed device is based on the previously cleared Stat Profile Prime CCS Analyzer System (K131703). The primary predicate for this proposed device is the Stat Profile pHOx Ultra Analyzer System (K110648).

The Stat Profile Prime Plus Analyzer has slots to accommodate two sensor cartridges (Primary and Auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed.

# Primary Sensor Card Port:

There are two options for the primary sensor card:

- . Primary Sensor Card 1 shall enable and report the following listed analytes: o sodium, potassium, chloride, ionized calcium, and ionized magnesium
- . Primary Sensor Card 2 shall enable and report the following listed analytes:
- sodium, potassium, chloride, ionized calcium, and ionized magnesium o

{4}------------------------------------------------

Similar to the primary predicate device, the Stat Profile Prime Plus Analyzer is a blood qas/cooximetry/electrolyte/chemistry and hematology analyzer with an enhanced test menu and multiple quality control options. Both traditional internal and external quality control will be used, as well as an on-board Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly at all times.

The Stat Profile Prime Plus Analyzer accepts samples from syringes, open tubes, and small cups. The minimum sample size for analysis is 135 µL.

Sample collection, preparation and application to the analyzer are the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.

#### Stat Profile Prime Plus Analyzer System Components:

The Stat Profile Prime Plus Analyzer System is comprised of the following components.

- Stat Profile Prime Plus Analyzer System .
- Primary Sensor Cartridge
- Auxiliary Sensor Cartridge ●
- Stat Profile Prime Plus Auto-Cartridge Quality Control Pack ●
- Stat Profile Prime Plus Calibrator Cartridge ●
- Stat Profile Prime Plus External Ampuled Control ●
- IFU/Labeling .

#### Sample Types:

The Stat Profile Prime Plus Analyzer System accepts lithium heparinized arterial and venous whole blood.

#### Measured Parameters:

The Stat Profile Prime Plus Analyzer measures:

- . Sodium
- Potassium ●
- Chloride
- lonized Calcium ●
- Ionized Magnesium ●

#### Calculated Parameters:

The following parameters are calculated by the Prime Plus Analyzer based on results of the directly measured parameters.

- nCA to nMg Ratio (nCa/nMg)
- Normalized Calcium (nCa) ●
- Normalized Magnesium (nMq) .

#### Intended Use:

The Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings for quantitative determination of sodium, chloride, ionized calcium, and ionized magnesium in heparinized arterial and venous whole blood.

Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, or diseases involving electrolyte imbalance.

Potassium measurements are used in the diagnosis and treatment of disease conditions characterized by low or high potassium levels.

Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

lonized calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

{5}------------------------------------------------

lonized magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium),

## Summary of the Technological Characteristics:

The Stat Profile Prime Plus Analyzer is substantially equivalent to the previously cleared for market Stat Profile pHOx Ultra Analyzer System (K110648) in intended use. It uses the same sensor technology and measurement algorithms, and the formulations of the internal controls and the calibration cartridge are the same for the tested parameters. The External Control solutions for use with the Stat Profile Prime Plus Analyzer are substantially equivalent to those cleared for use with the predicate Stat Profile pHOx Ultra Analyzer System (K110648). See Table 1 for comparison of the predicate and proposed devices.

## Principles of Measurement:

Sodium, Potassium, Chloride, ionized Magnesium, and ionized Calcium

The parameters are measured by an lon-Selective Electrode (ISE) that selectively measures the activity of ionic species. When the ISE is contacted with a sample, potential is developed. The potential is proportional to the logarithm of the ionic activity and is measured versus a reference electrode.

## Method Comparison Studies:

A study was performed to compare the Stat Profile Prime Plus to the Nova Stat Profile pHOx Ultra analyzer to assess the equivalence of the analyzers in the measurement of sodium, potassium, chloride, ionized calcium, and ionized magnesium in heparinized whole blood in a clinical laboratory setting.

The blood comparison data for sodium, potassium, chloride, ionized calcium, and ionized magnesium for the Stat Profile Prime Plus analyzers meet the acceptance criteria.

# Precision/Reproducibility - Within Run and Run to Run Studies:

Within Run and Run to Run precision was evaluated by replication studies performed on three Stat Profile Prime Plus analyzers.

Within Run Precision testing consisted of one run of each of the following sample types and levels was performed, 20 replicates per run:

- . Stat Profile Prime Plus Internal Controls: Levels 4 - 5
- Stat Profile Prime Plus Ampuled Controls: Levels 4 5 ●
- Three whole bloods, sampled from syringes ●

To assess Run to Run Precision for whole blood, triplicate analyses were performed on four whole blood sample in ten separate runs during a single day. The systems were recalibrated before each triplicate run.

The precision data for all parameters meet the within run imprecision specifications for the Stat Profile Prime Plus analyzers.

The precision data for all parameters meet the between analyzer run to run imprecision specifications for the Stat Profile Prime Plus analyzers.

# Linearity Testing:

The study assessed the linearity of all parameters to establish and/or verify the Analytical Measurement Range (AMR) for the Stat Profile Prime Plus Analyzer on whole blood. The linearity was measured using method comparison. The evaluation of the linear range included lower and upper limits of the AMR and various medical decision limits.

All Stat Profile Prime Plus results were compared to the reference analyzer and/or the product specifications.

The linearity comparison data for all parameters for the Stat Profile Prime Plus analyzers shows good correlation and linearity to the reference analyzers across the claimed measurement range for all parameters and met the acceptance criteria.

{6}------------------------------------------------

# Specificity / Interference Testing:

The purpose of this study was to identify substances that may interfere with the Stat Profile Prime Plus sensors. If interference was identified, a dose response study was performed to determine the concentration where the interfering substance may alter results.

This Interference Testing study was performed using whole blood collected in lithium heparin vacutainers. The possible interfering substances were tested at two analyte concentrations.

Many substances were screened as potential interferents through analysis on the Prime Plus analyzers. Substance screening was completed according to the CLSI EP7-A2 guideline. The interfering substances identified during the screening process are listed in the table below:

| Parameter | Interfering Substance | Concentration of<br>interfering<br>substance | Interference |
|----------------------|-----------------------|----------------------------------------------|--------------------------|
| Chloride | Bromide | 2.5 mmol/L | No interference observed |
| | | 5.0 mmol/L | Bias of 12.5% |
| | Thiocyanate | 3.4 mmol/L | No interference observed |
| | | 5.1 mmol/L | Bias of 18.5% |
| Ionized Calcium | MgCl2 | 3.75 mmol/L | No interference observed |
| | | 7.50 mmol/L | Bias of 11.97% |
| Ionized<br>Magnesium | Perchlorate | 0.06 mmol/L | No interference observed |
| | | 0.13 mmol/L | Bias of -19.14% |
| | Thiocyanate | 0.4 mmol/L | No interference observed |
| | | 0.9 mmol/L | Bias of -17.28% |
| | ZnCl2 | 0.163 mg/dL | No interference observed |
| | | 0.325 mg/dL | Bias of 11.11% |

#### Conclusion:

The results of software validation and performance verification testing confirmed that the Stat Profile Prime Plus Analyzer is safe and effective for its intended purpose and that the Stat Profile Prime Plus Analyzer System is substantially equivalent to that of the predicate Stat Profile pHOx Ultra Analyzer System (K110648).

{7}------------------------------------------------

# Table 1: Comparison of Predicate and Proposed devices

| Characteristic | Predicate: K110648 - Stat Profile pHOx Ultra Analyzer | Proposed: Stat Profile Prime Plus Analyzer |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication For Use | The Stat Profile pHOx Ultra Analyzer without CO-Oximeter is intended for in<br>vitro diagnostic use by health care professionals and/or point-of-care usage in the<br>quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct),<br>Hemoglobin (Hb) in heparinized whole blood; Na+, K'-, Cl-, Ca++, Mg++, Glucose<br>(Glu), Lactate (Lac), BUN (Urea), and Creatinine (Great) in heparinized whole<br>blood, serum, or plasma.<br><br>The Stat Profile pHOx Ultra Analyzer with CO-Oximeter is intended for in vitro<br>diagnostic use by health care professionals and for point-of-care usage in the<br>quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), total<br>Hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb),<br>Methemoglobin (MetHb), Deoxyhemoglobin (HHb), and total bilirubin (tBil) in heparinized whole blood; Nat, K'-, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac),<br>BUN (Urea), and Creatinine (Creat) in Heparinized whole blood, serum, or plasma. Total Bilirubin (tBil) was not evaluated on neonatal samples. | The Stat Profile Prime Plus Analyzer System is indicated for use by<br>healthcare professionals in clinical laboratory settings for quantitative<br>determination of sodium, potassium, chloride, ionized calcium, and ionized<br>magnesium in heparinized arterial and venous whole blood. |
| Acceptable Samples | | |
| Sample Types | Sodium or lithium heparinized whole blood, serum, or plasma samples from<br>syringes, open tubes, small cups, and capillary tubes. | Lithium heparin whole blood from syringes, open tubes, small cups, and<br>capillary tubes. |
| Sample Volumes | 60-200µL (dependent on panel selected) | 135µL |
| Measurement Range | | |
| Sodium | 80 - 200 mmol/L | 80 - 200 mmol/L |
| Potassium | 1.0 - 20.0 mmol/L | 1.0 - 20.0 mmol/L |
| Chloride | 50 - 200 mmol/L | 50 - 200 mmol/L |
| Ionized Calcium | 0.1 - 2.7 mmol/L | 0.4 - 10.8 mg/dL |
| Ionized Magnesium | 0.1 - 1.5 mmol/L | 0.24 - 3.65 mg/dL |
| Principles of<br>Measurement | | |
| Sodium | Ion-Selective Electrode | Same |
| Potassium | Ion-Selective Electrode | Same |
| Chloride | Ion-Selective Electrode | Same |
| Ionized Calcium | Ion-Selective Electrode | Same |
| Ionized Magnesium | Ion-Selective Electrode | Same |
| Sodium | | |
| Touch Screen | 12.1" LCD, 1024x768 pixel, Resistive Touch | 10.1" WXGA 1280 x 800 color touch screen |
| Menu | Fully configurable test menu based on available sensors | Same |
| Bar Code Scanner | Internal Integrated 1D/2D | Same |
| Printer | 2" Roll, Thermal Transfer | Same |
| Pump | Peristaltic Pump w/ Pressure Plate, TPE Tubing (Pharmed BPT) | Same |
| Analog Board | Precision low level analog front end w/ amperometric and potentiometric<br>amplifiers, air detector circuitry and temperature control circuitry | Same |