NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM

K131703 · Nova Biomedical Corporation · CHL · Mar 25, 2014 · Clinical Chemistry

Device Facts

• Record ID: K131703
• Device Name: NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM
• Applicant: Nova Biomedical Corporation
• Product Code: CHL · Clinical Chemistry
• Decision Date: Mar 25, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Intended Use

The Stat Profile Prime CCS Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, and Glu (Glucose), in heparinized whole blood. PCO2, PO2, pH: Whole blood measurement of certain gases in whole blood, or pH of whole blood, is used in the diagnosis and treatment of life-threatening acid-base disturbances. Hct: Whole blood measurements of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells). Na+: Sodium measurement is used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison’s disease, dehydration, or diseases involving electrolyte imbalance. K+: Potassium Measurement is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels. Cl-: Chloride measurement is used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. iCa: 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). Glu: Glucose measurement is used in the diagnosis and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. The Stat Profile Prime Auto QC Cartridge CCS is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of the Stat Profile Prime CCS Analyzer. The Stat Profile Prime Ampuled Control ABG/CCS is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Stat Profile Prime CCS Analyzer. The Stat Profile Prime Calibrator Cartridge CCS is intended for the calibration of pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, and Glucose using the Stat Profile Prime CCS Analyzer. Linearity Standard Set A is intended for in vitro diagnostic use with Stat Profile Prime CCS Analyzers to verify calibration, analytical linearity, estimate test imprecision, and detect systematic analytical deviations that may arise from calibrator cartridge or analytical instrument variation.

Device Story

Stat Profile Prime CCS Analyzer is a microprocessor-based, automated blood gas, metabolite, and electrolyte analyzer for clinical laboratory use. It processes heparinized whole blood samples (syringes, tubes, capillary devices) aspirated via peristaltic pump into a disposable, integrated micro-sensor card. The card contains all sensors: hydrogen ion-selective membrane (pH); Severinghaus-type (pCO2); Clark-type polarographic (pO2); impedance (Hct); ion-selective electrodes (Na+, K+, Cl-, iCa); and enzyme/amperometric (glucose). After analysis, samples are flushed into a waste bag within the calibrator cartridge. The system performs automated 1-point and 2-point calibrations using internal aqueous standards. Quality control is managed via on-board Auto QC cartridges or external ampules. Healthcare providers use the quantitative results to diagnose and monitor life-threatening acid-base disturbances, electrolyte imbalances, and metabolic disorders like diabetes. The device benefits patients by providing rapid, accurate diagnostic data for critical care decision-making.

Clinical Evidence

Bench testing only. Studies included method comparison, within-run and run-to-run precision/reproducibility, linearity, specificity/interference, and detection limit verification. Results confirmed performance is substantially equivalent to the predicate device.

Technological Characteristics

Microprocessor-based analyzer using replaceable microsensor cards. Sensors: Hydrogen ion-selective (pH), Severinghaus (PCO2), Polarographic Clark-type (PO2), Impedance (Hct), Ion-selective electrodes (Na+, K+, Cl-, iCa), and Enzyme/Amperometric (Glucose). Features 5.7" VGA touch display, internal 1D/2D barcode scanner, and thermal printer. Peristaltic pump with TPE tubing. Automated calibration and QC via internal cartridges or external ampules. Standalone operation.

Indications for Use

Indicated for healthcare professionals in clinical laboratory settings to quantitatively measure pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, and Glucose in heparinized whole blood for the diagnosis and treatment of acid-base disturbances, electrolyte imbalances, metabolic disorders, and carbohydrate metabolism disturbances.

Regulatory Classification

Identification

A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Predicate Devices

• Nova Stat Profile pHOx Ultra Analyzer System (k110648)

Submission Summary (Full Text)

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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: | Paul W. MacDonald |
| Date Prepared: | 21 March 2014 |

Proprietary Name: Stat Profile® Prime CCS Analyzer System, Stat Profile Prime Auto QC Cartridge CCS, Stat Profile Prime Ampuled Control ABG/CCS, Stat Profile Prime Calibrator Cartridge CCS/CCS Comp and Linearity Standard Set A

Common or Usual Name: Blood Gas/Electrolyte/Metabolite/CO-Oximetry Analyzer

Classification Name: Multiple

| Classification Names: | Class No. | Reg. No. | Class |
|-----------------------------------|-----------|----------|-------|
| Blood Gases and Blood pH system | 75CHL | 862.1120 | II |
| Sodium Test System | 75JGS | 862.1665 | II |
| Potassium Test System | 75CEM | 862.1600 | II |
| Calcium Test System | 75JFP | 862.1145 | II |
| Chloride Test System | 75CGZ | 862.1170 | II |
| Glucose Test System | 75CGA | 862.1345 | II |
| Instrument, Hematocrit, Automated | 81GKF | 864.5600 | II |
| Calibrators | 75JIX | 862.1150 | II |
| Quality Control Materials | 75JJS | 862.1660 | II |

Product Codes: CHL, JGS, CEM, JFP, CGZ, CGA, GKF, JIX, JJS

Predicate Device: K110648 - Nova Stat Profile pHOx Ultra Analyzer System (including controls, calibrators and Linearity Standards)

## Device Description:

The Stat Profile Prime CCS Analyzer is a small, low cost blood gas, metabolite and electrolyte analyzer for laboratory use. The sensors and flow path have been integrated into one replaceable microsensor card, which is replaced periodically according to usage. The product, consumables, installation instructions and packaging are designed for easy customer installation.

Whole blood specimens are aspirated into the analyzer's microsensor card from syringes, tubes, or capillary blood collection devices using a peristaltic pump and a sampling probe. The disposable microsensor card contains the analytical flowpath and all of the measurement sensors (pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, and Glu (Glucose). Once the analysis measurement is complete, the whole blood specimen is automatically flushed out of the microsensor card flowpath and into a self contained waste collection bag contained within the disposable calibrator carridge.

The Stat Profile Prime CCS Analyzer will have an enhanced test menu and multiple quality control options. Both traditional Internal and External liquid QC shall be offered, as well as an onboard Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly.

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As with the predicate, the Stat Profile Prime CCS Analyzer is microprocessor-based and incorporates:

- . traditional sensor technology to measure blood pO2
- ion selective electrode technology to measure pH, pCO₂, blood sodium, potassium, . chloride, and ionized calcium
- enzyme/Amperometric technology for glucose measurements .

Liquid quality control materials are available as internal auto-cartridge quality control packs and as external ampules. The sampling, calibration and quality control functions are fully automated.

Internal Calibration standards with dissolved gases are provided in sealed pouches eliminating the need for users to calibrate the blood gas electrodes using external compressed gas cylinders. The Calibration Cartridges contain aqueous solutions within individual flexible bags housed in a cardboard box and a flexible waste bag. Each bag includes a fitment with a septa that is pierced during the insertion of the cartridge into the analyzer. The Calibration Cartridge aqueous solutions allow for 2 point calibration of each parameter as follows.

- Calibrator A pH, PCO2, Na, K, Cl, iCa, and Glu (Volume > 500 mL) .
- Calibrator B pH, PO2, Na, K, Cl, iCa, and Glu (Volume > 250 mL) .
- . Calibrator F - PCO2, PO2 (Volume > 720 mL)
- Reference Solution KCI (Volume > 300 mL) .

The external glass ampule controls contain a buffered bicarbonate solution with a known pH and known levels of Na, K, CI, iCa, and Glu. The solutions are equilibrated with known levels of O2, CO2, and N2. Each ampule contains 1.7 ml volume.

The internal auto QC cartridge consists of 3 flexible bags within a cardboard carton. Each bag contains an aqueous quality control material for monitoring the measurement of pH, PCO2, PO2, hematocrit (Hct) Na, K, Cl, iCa, and Glucose (Glu). The aqueous quality control materials are composed of a buffered bicarbonate solution, each with a known pH and known level of Na, K, Cl, iCa, and Glu. Solutions are equilibrated with known levels of O2, CO2, and N2. Each bag contains a minimum volume of 100 mL. The aqueous quality control materials are formulated at three levels:

- . Control 1: Acidosis, with High Electrolyte, Low Normal Glu
- . Control 2: Normal pH, Low-Normal Hct, Normal Electrolyte, High Glu
- Control 3: Alkalosis, High Hct, Low Electrolyte, High Abnormal Glu, .

Linearity Standard Set A consists of ampuled buffered solutions containing Ca++, Glu, K+, and Cl-. Each ampule contains 1.8 ml volume.

The Stat Profile Analyzer accepts Lithium heparin whole blood sample from syringes, open tubes, small cups, and capillary tubes. The minimum sample size for both syringe and capillary samples analysis is 100 µL.

### Measured Parameters:

The Stat Profile Prime CCS Analyzer measures pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, and Glu (Note: Glucose is optional).

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## Calculated Parameters:

- . pH, PCO2, PO2 (corrected to patient temperature)
- . Bicarbonate level (HCO3-)
- Total Carbon Dioxide (TCO2) .
- Base Excess of the blood (BE-b) .
- Base Excess of extracellular fluid (BE-ecf) .
- Standard Bicarbonate Concentration (SBC) .
- . Oxygen Content (O2Ct)
- . Oxygen Capacity (O2Cap)
- Alveolar Oxygen (A) .
- Arterial Alveolar Oxygen Tension Gradient (AaDO2) .
- Arterial Alveolar Oxygen Tension Ratio (a/A) .
- Respiratory Index (RI) .
- P50 .
- PO2/FIO2 ratio .
- Oxygen Saturation (SO2%) .
- Hemoglobin .
- Anion Gap .
- Normalized Calcium, nCa ●

## Intended Use:

The Stat Profile Prime CCS Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, and Glu (Glucose), in heparinized whole blood.

| PCO2,<br>PO2,<br>pH | Whole blood measurement of certain gases in whole blood, or pH of whole blood, is used in the<br>diagnosis and treatment of life-threatening acid-base disturbances. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Hct | Whole blood measurements of the packed red cell volume of a blood sample are used to<br>distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the<br>number of red cells). |
| Na+ | Sodium measurement is used in the diagnosis and treatment of aldosteronism, diabetes<br>insipidus, adrenal hypertension, Addison's disease, dehydration, or diseases involving<br>electrolyte imbalance. |
| K+ | Potassium Measurement is used to monitor electrolyte balance in the diagnosis and treatment of<br>disease conditions characterized by low or high potassium levels. |
| Cl- | Chloride measurement is used in the diagnosis and treatment of electrolyte and metabolic<br>disorders such as cystic fibrosis and diabetic acidosis. |
| iCa | Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a<br>variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or<br>spasms). |
| Glu | Glucose measurement is used in the diagnosis and treatment of carbohydrate metabolism<br>disturbances including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia,<br>and of pancreatic islet cell carcinoma. |

Stat Profile Prime Auto QC Cartridge CCS is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of the Stat Profile Prime CCS Analyzer.

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Stat Profile Prime Ampuled Control ABG/CCS is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Stat Profile Prime CCS Analyzer.

Stat Profile Prime Calibrator Cartridge CCS is intended for the calibration of pH, PCO2, PO2, Hct, Na*, K*, Cl , iCa, and Glucose, using the Stat Profile Prime CCS Analyzer.

Linearity Standard Set A is intended for in vitro diagnostic use with Stat Profile Prime CCS Analyzers to verify calibration, analytical linearity, estimate test imprecision, and detect systematic analytical deviations that may arise from calibrator cartridge or analytical instrument variation.

## Summary of the Technological Characteristics:

The Stat Profile Prime CCS Analyzer is substantially equivalent to the previously cleared for market Nova Stat Profile pHOx Ultra Analyzer System in intended use. It uses the same sensor technology and measurement algorithms, and the formulations of the internal and external controls and the calibration cartridge are the same for the tested parameters. The Linearity Standard Set A for use with the Stat Profile Prime CCS Analyzer is identical to those cleared for use with the predicate Nova Stat Profile pHOx Ultra Analyzer System.

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| Characteristic | Table 1: Comparison of Predicate and Proposed devices<br>Predicate: K110648 Stat Profile pHOx Proposed: Stat Profile Prime CCS Analyzer<br>Ultra Analyzer | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication For Use | The STP pHOx Ultra Analyzer without CO-Oximeter is intended for <i>in vitro</i> diagnostic use by health care professionals and/or point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Hemoglobin (Hb) in heparinized whole blood; Na+, K+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma. | The Stat Profile Prime CCS Analyzer System is intended for <i>in vitro</i> diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, and Glu (Glucose), in heparinized whole blood. |
| | | PCO2, Whole blood measurement of blood gases is used in the diagnosis and treatment of life-threatening acid-base disturbances in critically ill patients with numerous metabolic and pulmonary diseases. |
| | | PO2,<br>pH |
| | | Hct |
| | | Whole blood measurements of hematocrit are used to estimate that red blood cells are present in sufficient quantity to carry oxygen and carbon dioxide. |
| | | Na+ |
| | | Sodium measurement is used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, or diseases involving electrolyte imbalance. |
| | | K+ |
| | | Potassium Measurement is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels. |
| | | Cl- |
| | | Chloride measurement is used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. |
| | | iCa |
| | | Ionized Calcium measurement is used in the diagnosis and treatment of hypertension, renal disease, and vitamin D related disorders. Also useful in the diagnosis and treatment of patients with increased total protein and/or albumin levels, as in dehydration. |
| | | Glu |
| | | Glucose measurement is used in the diagnosis and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. |
| Acceptable Samples | Sodium or lithium heparinized whole | Lithium heparinized whole blood from syringes, open tubes, small cups, and |
| Characteristic | Predicate: K110648 Stat Profile PHOx<br>Ultra Analyzer | Proposed: Stat Profile Prime CCS Analyzer |
| | blood, serum, or plasma samples from<br>syringes, open tubes, small cups, and<br>capillary tubes. | capillary tubes. |
| Sample Volumes | 100µL (syringe and capillary) | 100µL (syringe and capillary) |
| Measurement Range | | |
| pH | 6.500-8.000 | Same |
| PCO2 | 3.0 -200 mmHg | Same |
| PO2 | 0-800 mmHg | 5-765 mmHg |
| Hct | 12%-70% | Same |
| Na+ | 80-200 mmol/L | Same |
| K+ | 1.0-20.0 mmol/L | Same |
| Cl- | 50-200 mmol/L | Same |
| Ca (Ca++) | 0.10-2.70 mmol/L | 0.20-2.70 mmol/L |
| Glu | 15-500 mg/dL | Same |
| Principles of<br>Measurement | | |
| pH | Hydrogen ion-selective sensor | Same |
| PCO2 | Severinghaus-type sensor | Same |
| PO2 | Polarographic Clark-type sensor | Same |
| Hct | Impedance sensor | Same |
| Na+ | Sodium ion-selective sensor | Same |
| K+ | Potassium ion-selective sensor | Same |
| Cl- | Chloride ion-selective sensor | Same |
| Ca (Ca++) | Calcium ion-selective sensor | Same |
| Characteristic | Predicate: K110648 Stat Profile pHOx Ultra Analyzer | Proposed: Stat Profile Prime CCS Analyzer |
| Glu | Glucose Oxidase Enzymatic sensor | Same |
| Touch Screen | 12.1" LCD, 1024x768 pixel, Resistive Touch | 5.7" VGA full color display with LED backlight and integrated touch panel |
| Menu | Fully configurable test menu based on above sensors | Same |
| Bar Code Scanner | External (optional) 1D | Internal Integrated 1D/2D |
| 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 amplifiers, air detector circuitry and temperature control circuitry | Same |
| Characteristic | Predicate: K110648 Stat Profile pHOx Ultra Calibrator Cartridge | Proposed: Stat Profile Prime Calibrator Cartridge CCS |
| Indication For Use | The intended use of the Nova STP pHOx Ultra Calibrator Cartridge is for the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Hemoglobin (Hb) in heparinized whole blood; Na+, K+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma. | The Stat Profile Prime Calibrator Cartridge CCS is intended for the calibration of pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, and Glucose using the Stat Profile Prime CCS Analyzer. |
| Configuration | 2 level calibration standards per analyte, and reference solution | Same |
| Packaging | Liquid in Mylar bags inside cardboard container. Includes a waste collection bag. Self-contained, disposable packaging. | Same |
| Characteristic | Predicate: K110648 Stat Profile pHOx Ultra/CCX ABG and CO-Oximeter Controls | Proposed: Stat Profile Prime Auto QC Cartridge CCS |
| Indication For Use | | |
| Nova STP pHOx Ultra/CCX ABG and CO-Oximeter Controls and<br>Autocartridge QC are intended for in vitro diagnostic use by<br>healthcare professionals for monitoring the performance of Nova<br>STP pHOx Ultra/CCX Analyzers. | The Stat Profile Prime Auto QC Cartridge CCS is a<br>quality control material intended for in vitro diagnostic<br>use by healthcare professionals for monitoring the<br>performance of the Stat Profile Prime CCS Analyzer. | |
| Configuration | 3 level aqueous electrolyte, metabolite and gas solutions. | Same |
| Packaging | Cartridge: Solution in Mylar bags inside cardboard container.<br>Includes a waste collection bag. Self-contained, disposable<br>packaging. | Same |
| Characteristic | Predicate: K110648 Stat Profile pHOx Ultra/CCX ABG and CO-Oximeter Controls | Proposed: Stat Profile Prime Ampuled Control ABG/CCS |
| Indication For Use | Nova STP pHOx Ultra/CCX ABG and CO-Oximeter Controls and Autocartridge QC are intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Nova STP PHOx Ultra/CCX Analyzers. | The Stat Profile Prime Ampuled Control ABG/CCS is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Stat Profile Prime CCS Analyzer. |
| Configuration | 3 level aqueous electrolyte, metabolite and gas solutions. | Same |
| Packaging | Ampules: Each glass ampule contains 1.7 ml volume. | Same |

Table 1: Comparison of Predicate and Proposed device

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| Characteristic | Predicate: K110648 Stat Profile pHOx Ultra Linearity Standards | Proposed: Linearity Standard Set A |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication For Use | For in vitro diagnostic use with NOVA, Stat Profile/Ultra, Stat Profile pHOx Plus/L/C/M, Stat Profile pHOx<br>Ultra, Stat Profile Prime CCS, and Stat Profile CCX Analyzers to verify calibration, analytical linearity,<br>estimate test imprecision, and detect systematic analytical deviations that may arise from calibrator cartridge or analytical instrument variation. | The Linearity Standard Set A is intended for in vitro diagnostic use with Stat Profile Prime CCS Analyzers<br>to verify calibration, analytical linearity, estimate test imprecision, and detect systematic analytical deviations that may arise from calibrator cartridge or analytical instrument variation. |
| Configuration | 4 level aqueous solutions in glass ampules. Contain electrolyte, metabolite and gas solutions. | Same |
| Packaging | Ampules: Each glass ampule contains 1.8 ml volume | Same |

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## Summary of Performance Testing:

Bench testing was completed to demonstrate that the Stat Profile Prime CCS Analyzer is substantially equivalent in performance, safety and efficacy to the Stat Profile pHOx Ultra Analyzer System.

The bench testing included:

- . Method Comparison Studies
- Precision/Reproducibility Studies .
- Run to Run Precision .
- Within Run Precision .
- . Linearity Testing
- Specificity / Interference Testing .
- Detection Limit ●

The results of the testing confirmed that the performance of the Stat Profile Prime CCS Analyzer System is substantially equivalent to that of the Nova Stat Profile pHOx Ultra Analyzer System (predicate device).

### Conclusion:

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

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Image /page/9/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

March 25, 2014

NOVA BIOMEDICAL CORPORATION PAUL MACDONALD CHIEF OFFICER, QA & REG. AFFAIRS 200 PROSPECT ST WALTHAM MA 02454

Re: K131703

Trade/Device Name: Nova Stat Profile Prime CCS Analyzer System, Stat Profile Prime Auto QC Cartridge CCS, Stat Profile Prime Ampuled Control ABG/CCS, Stat Profile Prime Ampuled Control ABG/CCS, Stat Profile Prime Calibrator Cartridge CCS/CCS Comp, Nova Linearity Standard Set A Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (PCO2, PO2) and blood pH test system Regulatory Class: II Product Code: CHL, JGS, CEM, JFP, CGZ, CGA, GKF, JIX, JJS Dated: February 19, 2014 Received: February 20, 2014

Dear Mr. 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. Iisting 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 (2) CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements

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Page 2-Mr. MacDonald

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.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 80) and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Courtney H. Lias -S

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 on last page.

### 510(k) Number (if known)

## K131703

Device Name

Stat Profile® Prime CCS Analyzer System, Stat Profile Prime Auto QC Cartridge CCS, Stat Profile Prime Ampuled Control ABG/CCS, Stat Profile Prime Calibrator Cartridge CCS/CCS Comp and Linearity Standard Set A

#### Indications for Use (Describe)

The Stat Profile Prime CCS Analyzer System is intended for in vitro diagnostic use by health care professionals in cilnical faboratory settings for the quantitative determination of pH, PCO2, PO2, Hct, Na+, K+, Cl-, ICa, and Glu (Glucose), In heparinized whole blood.

PCO2, PO2, pH: Whole blood measurement of certain gases in whole blood, or pH of whole blood, is used in the diagnosis and treatment of life-threatening acid-base disturbances.

Hct: Whole blood measurements of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).

Na +: Sodium measurement is used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, or diseases involving electrolyte imbalance.

K+: Potassium Measurement is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels.

Cl-: Chloride measurement is used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

ICa: 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).

Glu: Glucose measurement is used in the diagnosis and treatment of carbohydrate metabollsm disturbances Including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The Stat Profile Prime Auto QC Cartridge CCS is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of the Stat Profile Prime CCS Analyzer.

The Stat Profile Prime Ampuled Control ABG/CCS is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Stat Profile Prime CCS Analyzer.

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510(k) Number (if known)

## K131703

Device Name

Stat Profile® Prime CCS Analyzer System, Stat Profile Prime Auto QC Cartridge CCS, Stat Profile Prime Ampuled Control ABG/CCS, Stat Profile Prime Calibrator Cartridge CCS/CCS Comp and Linearity Standard Set A

The Stat Profile Prime Calibrator Cartridge CCS is intended for the callbration of pH, PCO2, PO2, Hct, Na+, K+, C-, ICa, and Glucose using the Stat Profile Prime CCS Analyzer.

Linearity Standard Set A is intended for in vitro diagnostic use with Stat Profile Prime CCS Analyzers to verify calibration, analytical linearity, estimate test imprecision, and detect systematic analytical deviations that may arise from callbrator cartridge or analytical instrument variation.

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

8 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Yung W. Chan -S

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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…