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

Indications for 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) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY AND INSTRUMENT COMBINATION TEMPLATE

A. 510(k) Number:
k131703

B. Purpose for Submission:
New device

C. Measurand:
pH, pCO2, pO2, Hematocrit (Hct), Sodium (Na+), Potassium (K+), Chloride (Cl-), Ionized calcium (iCa), and Glucose (Glu)

D. Type of Test:
Quantitative: Traditional electrode technology to measure blood pH, pCO2, pO2;
Ion selective electrode technology to measure blood Na+, K+, Cl-, iCa;
Enzyme/Amperometric technology for glucose measurement;
Conductivity method for hematocrit measurement

E. Applicant:
Nova Biomedical Corporation

F. Proprietary and Established Names:
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
Nova Linearity Standard Set A

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G. Regulatory Information:

| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| CHL | II | 862.1120, Blood Gases (pCO2, pO2) and Blood pH system | 75-Chemistry |
| JGS | II | 862.1665, Sodium Test System | 75-Chemistry |
| CEM | II | 862.1600, Potassium Test System | 75-Chemistry |
| JFP | II | 862.1145, Calcium Test System | 75-Chemistry |
| CGZ | II | 862.1170, Chloride Test System | 75-Chemistry |
| CGA | II | 862.1345, Glucose Test System | 75-Chemistry |
| GKF | II | 864.5600, Automated hematocrit instrument | 81-Hematology |
| JIX | II | 862.1150, Calibrators | 75- Chemistry |
| JJS | I | 862.1660, Quality Control Materials | 75-Chemistry |

H. Intended Use:

1. Intended use(s):

See indications for use below.

2. Indication(s) for 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

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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 Ampuiled 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.

3. Special conditions for use statement(s):

For prescription use only.

Not for point of care use.

4. Special instrument requirements:

Stat Profile Prime CCS Analyzer

I. Device Description:

1. Stat Profile Prime CCS Analyzer

The Stat Profile Prime CCS Analyze is a small, automatic blood gas, metabolite and electrolyte analyzer. The sensors and flow path have been integrated into one replaceable micro-sensor card, which is replaced periodically according to usage. Whole blood specimens are aspirated into the analyzer's micro-sensor card from syringes, tubes, or capillary blood collection devices using a peristaltic pump and a sampling probe. The disposable micro-sensor card contains the analytical flow-path and all of the

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measurement sensors (pH, pCO2, pO2, Hct, Na+, K+, Cl-, iCa, and Glu). Once the analysis measurement is complete, the whole blood specimen is automatically flushed out of the micro-sensor card flow-path and into a self-contained waste collection bag contained within the disposable calibrator cartridge.

The Stat Profile Prime CCS Analyzer is microprocessor-based and incorporates: Traditional electrode technology to measure blood pH, pCO2, pO2; Ion selective electrode technology to measure blood sodium, potassium, chloride, ionized calcium; Enzyme/Amperometric technology for glucose measurement; Conductivity method for Hematocrit. The Stat Profile Prime CCS Analyzer has multiple quality control options. Both traditional internal and external liquid QC shall be offered, as well as an onboard Quality Management System (QMS). The Stat Profile Prime CCS Analyzer has two primary sample modes: syringe and capillary mode. The minimum sample size for both analysis modes is 100 μL.

2. Stat Profile Prime Auto QC cartridge CCS

This 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

Control Ranges:

| Stat Profile Prime Auto QC Cartridge CCS | | | | |
| --- | --- | --- | --- | --- |
| Analyte | Units of measure | Control 1 min - max | Control 2 min - max | Control 3 min - max |
| pH | | 7.130 - 7.180 | 7.347 - 7.397 | 7.558 - 7.608 |
| H+ | nmol/L | 74.13 - 66.07 | 44.98 - 40.09 | 27.67 - 24.66 |
| PCO2 | mmHg | 61.9 - 71.9 | 39.7 - 45.7 | 19.7 - 25.7 |
| PO2 | mmHg | 52.4 - 64.4 | 95.0 - 107.0 | 135.0 - 155.0 |
| HCT | % | 33 - 37 | 49 - 55 | 63 - 69 |
| Na | mmol/L | 159.7 - 167.7 | 137.5 - 145.5 | 115.0 - 123.0 |
| K | mmol/L | 5.48 - 6.08 | 3.54 - 4.04 | 1.67 - 2.07 |
| Cl | mmol/L | 124.1 - 133.1 | 97.2 - 106.2 | 80.6 - 90.6 |
| iCa | mmol/L | 1.48 - 1.68 | .94 - 1.10 | .50 - .62 |
| Glu | mg/dL | 76 - 90 | 196 - 226 | 300 - 350 |

3. Stat Profile Prime Ampuled Control ABG/CCS

The composition of this liquid control is the same as Stat Profile Prime Auto QC

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cartridge. The packaging is different; it is offered as external ampules each contains 1.7 ml volume.

## 4. Stat Profile Prime Calibrator Cartridge CCS/CCS Comp

These 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 cartridge contains aqueous solutions within individual flexible bags housed in a cardboard box and a flexible waste bag. Each bag includes a fitment with septa that is pierced during the insertion of the cartridge into the analyzer. The calibrator aqueous solutions are:

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)

Target Values:

| Stat Profile Prime Calibrator Cartridge CCS/CCS Comp | | | | | |
| --- | --- | --- | --- | --- | --- |
| Analyte | Units of measure | Cal A ≥ 500 mL | Cal B ≥ 250 mL | Cal F ≥ 720 | R Solution ≥ 300 mL |
| pH | | 7.348 | 6.840 | -- | -- |
| pCO2 | mmHg | 24.5 | -- | 49.5 | -- |
| pO2 | mmHg | -- | -- | 99.7 | -- |
| Na | mmol/L | 133.0 | 72.0 | -- | -- |
| K | mmol/L | 4.0 | 10.0 | -- | -- |
| Cl | mmol/L | 106.0 | 46.0 | -- | -- |
| iCa | mmol/L | 1.10 | 2.20 | -- | -- |
| Glu | mg/dL | 80 | 200 | -- | -- |

## 5. Nova Linearity Standard Set A

There are four levels of standards (1, 2, 3, and 4). Each ampule contains 1.8 ml buffered solutions containing the following analytes.

Linearity Standard Set A ranges:

| Nova Linearity Standards Set A | | | | | |
| --- | --- | --- | --- | --- | --- |
| Analyte | Units of measure | Level 1 min - max | Level 2 min - max | Level 3 min - max | Level 4 min - max |
| pH | | 7.113 - 7.173 | 7.260 - 7.340 | 7.392 - 7.472 | 7.509 - 7.589 |
| H+ | nmol/L | 77.09 - 67.14 | 54.95 - 45.71 | 40.55 - 33.73 | 30.97 - 25.76 |
| Na+ | mmol/L | 95.0 - 103.0 | 105.0 - 113.0 | 133.0 - 141.0 | 183.8 - 193.8 |
| K+ | mmol/L | 1.79 - 2.39 | 3.61 - 4.21 | 5.38 - 6.18 | 7.41 - 8.21 |
| Cl- | mmol/L | 67.3 - 75.3 | 85.5 - 95.5 | 101.9 - 111.9 | 143.0 - 153.0 |
| Ca++ | mmol/L | 0.43 - 0.73 | 0.99 - 1.29 | 1.79 - 2.19 | 2.09 - 2.59 |
| Glu | mg/dL | 475 - 555 | 285 - 335 | 91 - 107 | 31 - 45 |

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J. Substantial Equivalence Information:

1. Predicate device name(s):
Nova Stat Profile pHOx Ultra Analyzer System

2. Predicate 510(k) number(s):
k110648

3. Comparison to predicate

| Items | Stat Profile pHOx Ultra Analyzer (Predicate Device, k110648) | Stat Profile Prime CCS (Proposed Device) |
| --- | --- | --- |
| Similarity/Differences | | |
| Intended Use | For the quantitative determination of pH, pCO2, pO2, Hct, Na+, K+, Cl-, iCa, and Glu in heparinized whole blood samples | Same |
| | Clinical laboratory and POC use | Clinical laboratory use only |
| Sample modes | Syringe mode or capillary mode | Same |
| Sample volumes | 100 μL for both syringe and capillary modes | Same |
| Measuring 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 |
| iCa | 0.10-2.70 mmol/L | 0.20-2.70 mmol/L |
| Glu | 15-500 mg/dL | Same |
| Principles of Measurement | | |
| | Hydrogen ion-selective glass sensor | Same |
| | Severinghaus-type sensor | Same |
| | Polarographic Clark-type sensor | Same |
| | Impedance sensor | Same |
| | Sodium ion-selective glass sensor | Same |

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| Items | Predicate device: Stat Profile pHOx Ultra Cartridge K110648 | Proposed device: Stat Profile Prime Calibrator Cartridge CCS/CCS Comp |
| --- | --- | --- |
| Intended Use | 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 |

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| Items | Predicate device: Stat Profile pHOx Ultra/CCX ABG and CO-Oximeter Controls (K110648) | Proposed device: Stat Profile Prime Auto QC Cartridge CCS |
| --- | --- | --- |
| Intended 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 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. |
| Configuration | 3 level aqueous electrolyte, metabolite and gas solutions. | Same |
| Packaging | Cartridge: Solution in Mylar bags inside cardboard container. Includes a waste collection bag. Self-contained, disposable packaging. | Same |
| Items | Predicate device: K110648 Stat Profile pHOx Ultra/CCX ABG and CO-Oximeter Controls | Proposed device: Stat Profile Prime Ampuled Control ABG/CCS |
| --- | --- | --- |
| Intended 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 |

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| Item | Predicate device: K110648 Stat Profile pHOx Ultra Linearity Standards | Proposed device: Linearity Standard Set A |
| --- | --- | --- |
| Indication For Use | For in vitro diagnostic use to verify calibration, analytical linearity, estimate test imprecision, and detect systematic analytical deviations that may arise from calibrator cartridge or analytical instrument variation. | Same |
| 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 |

# K. Standard/Guidance Document Referenced (if applicable):

CLSI EP5-A2: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition

CLSI EP6-A: Evaluation of Linearity of Quantitative Measurement Procedures, A Statistical Approach; Approved Guideline

CLSI EP7-A2: Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition

CLSI EP9-A2-IR: Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline-Second Edition

CLSI EP17-A: Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline

CLSI EP25-A: Evaluation of In Vitro Diagnostic Reagents; Approved Guideline - CLSI EP25-A

# L. Test Principle:

$\mathbf{pH}$ is measured using a hydrogen ion selective membrane. One side of the membrane is in contact with a solution of constant $\mathsf{pH}$ . The other side is in contact with a solution of unknown $\mathsf{pH}$ . A change in potential develops which is proportional to the $\mathsf{pH}$ difference of these solutions. This change in potential is measured against a reference electrode of constant potential.

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pCO2 is measured with a modified pH sensor. Carbon dioxide in the unknown solution makes contact with a hydrogen ion selective membrane CO2 diffuses across the membrane into a thin layer of bicarbonate buffer in response to partial pressure difference. This solution then becomes equilibrated with the external gas pressure of the fluid in contact with the outer surface of the membrane. CO2 in the solution becomes hydrated producing carbonic acid which results in a change in hydrogen ion activity. The measured potential is related to the logarithm of $P\mathrm{CO}2$ content of the sample after compensation of the measured potential of the pH sensor.

pO2 is measured amperometrically by the generation of a current at the sensor surface. As oxygen diffuses through a gas permeable membrane, the oxygen molecules are reduced at the cathode, consuming 4 electrons for every molecule of oxygen reduced. This flow of electrons is then measured by the sensor and is directly proportional to the partial pressure of oxygen.

Hematocrit is defined as the percentage of red blood cells to the total blood volume and can be obtained by measuring electrical resistance of the blood sample. Two standard solutions are used to calibrate the hematocrit sensor and to obtain the slope. The analyzer then measures the electrical resistance of the blood sample to obtain the hematocrit value. The hematocrit value obtained is corrected for the concentration of the sodium ion.

Glucose measurement is based on the level of $\mathrm{H}_2\mathrm{O}_2$ produced during the enzymatic reaction between glucose and oxygen molecules in the presence of the glucose oxidase enzyme. The current generated by the flow of electrons at the surface of the platinum sensor is proportional to the glucose concentration of the sample.

$\mathrm{Na+}$, $\mathrm{K+}$, $\mathrm{Cl}^{-}$, $\mathrm{iCa}$ are measured by ion selective electrodes. An electrical potential is developed according the Nernst Equation for a specific ion. When compared to a reference, this electrical potential is translated into voltage and then in to the ion concentration of the sample.

## M. Performance Characteristics (if/when applicable):

### 1. Analytical performance:

#### a. Precision/Reproducibility:

**Quality Control Within Run Precision Performance**

The protocol consisted of 20 replicates per run for each of 3 different quality control materials on each of 3 Stat Profile Prime CCS Analyzers. The average, SD, CV%, and N for each analyzer, for each QC level and parameter was calculated. All 3 analyzers yielded similar results. The results of one representative analyzer are summarized in the table below.

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Quality Control within-run results:

| Within Run Precision | | | | |
| --- | --- | --- | --- | --- |
| Parameter | n = 20 | QC# 1 | QC # 2 | QC# 3 |
| pH | Mean | 7.165 | 7.361 | 7.596 |
| pH units | SD | 0.001 | 0.002 | 0.002 |
| pCO2 | Mean | 56.7 | 41.6 | 23.6 |
| mmHg | SD | 0.2 | 0.3 | 0.3 |
| | CV% | 0.4 | 0.7 | 1.2 |
| pO2 | Mean | 70.1 | 108.8 | 142.2 |
| mmHg | SD | 0.3 | 0.6 | 0.7 |
| | CV% | 0.5 | 0.5 | 0.5 |
| Hct | Mean | 38 | 55 | 69 |
| % | SD | 0.5 | 0.5 | 0.5 |
| | CV% | 1.32 | 1.05 | 0.79 |
| Na | Mean | 158.1 | 140.2 | 120.4 |
| mmol/L | SD | 0.1 | 0.1 | 0.1 |
| | CV% | 0.1 | 0.1 | 0.1 |
| K | Mean | 5.80 | 3.84 | 1.88 |
| mmol/L | SD | 0.00 | 0.02 | 0.01 |
| | CV% | 0.08 | 0.43 | 0.64 |
| iCa | Mean | 1.51 | 0.97 | 0.52 |
| mmol/L | SD | 0.01 | 0.01 | 0.00 |
| | CV% | 0.33 | 0.92 | 0.90 |
| Cl | Mean | 131.0 | 102.3 | 84.7 |
| mmol/L | SD | 0.1 | 0.5 | 0.5 |
| | CV% | 0.1 | 0.4 | 0.6 |
| Glu | Mean | 74 | 200 | 320 |
| mg/dL | SD | 0.0 | 1.1 | 1.0 |
| | CV% | 0.0 | 0.5 | 0.3 |

Whole Blood Within Run Precision Performance

Estimates of the whole blood within run precision were evaluated in syringe mode and capillary mode using lithium heparinized whole blood samples. For each run, tonometered whole blood was analyzed 20 times on 3 Stat Profile Prime Analyzers for a total of 20 results per analyzer. Statistical analysis for each analyzer for both syringe mode and capillary mode was calculated. All 3 analyzers yielded similar results. The results of one representative analyzer are summarized in the table below.

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Within-Run Precision Summary - Whole Blood - Capillary

| Within Run Precision | | |
| --- | --- | --- |
| Parameter | n = 20 | Analyzer # 1 |
| pH | Mean | 7.388 |
| pH units | SD | 0.004 |
| pCO2 | Mean | 34.5 |
| mmHg | SD | 0.5 |
| | CV% | 1.6 |
| pO2 | Mean | 119.0 |
| mmHg | SD | 0.9 |
| | CV% | 0.8 |
| Hct | Mean | 47 |
| % | SD | 0.6 |
| | CV | 1.28 |
| Na | Mean | 146.7 |
| mmol/L | SD | 0.9 |
| | CV% | 0.6 |
| K | Mean | 3.84 |
| mmol/L | SD | 0.07 |
| | CV% | 1.73 |
| iCa | Mean | 1.06 |
| mmol/L | SD | 0.02 |
| | CV% | 2.05 |
| Cl | Mean | 109.8 |
| mmol/L | SD | 0.3 |
| | CV% | 0.3 |
| Glu | Mean | 81 |
| mg/dL | SD | 1.4 |
| | CV% | 1.7 |

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Within-Run Precision Summary - Whole Blood - Syringe

| Within Run Precision | | |
| --- | --- | --- |
| Parameter | n = 20 | Analyzer # 1 |
| pH | Mean | 7.285 |
| pH units | SD | 0.003 |
| pCO2 | Mean | 48.1 |
| mmHg | SD | 0.8 |
| | CV% | 1.6 |
| pO2 | Mean | 68.9 |
| mmHg | SD | 0.3 |
| | CV% | 0.5 |
| Hct | Mean | 42 |
| % | SD | 0.8 |
| | CV% | 1.9 |
| Na | Mean | 140.5 |
| mmol/L | SD | 0.3 |
| | CV% | 0.2 |
| K | Mean | 3.75 |
| mmol/L | SD | 0.02 |
| | CV% | 0.59 |
| iCa | Mean | 1.21 |
| mmol/L | SD | 0.00 |
| | CV% | 0.38 |
| Cl | Mean | 104.3 |
| mmol/L | SD | 0.6 |
| | CV% | 0.6 |
| Glu | Mean | 63 |
| mg/dL | SD | 0.9 |
| | CV% | 1.4 |

# QC Total Precision Performance

Estimates of the total precision were evaluated for the Stat Profile Prime CCS analyzers by analyzing 3 levels of QC materials in duplicate over a period of 20 days; 2 runs per day for a total of 40 runs.

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QC Total Precision Results are summarized in the below tables.

| pH Precision Data | | | | |
| --- | --- | --- | --- | --- |
| Sample | Mean (pH unit) | N | Within run SD (Sr) | Total imprecision SD (St) |
| QC Level 1 | 7.164 | 240 | 0.002 | 0.002 |
| QC Level 2 | 7.362 | 240 | 0.000 | 0.001 |
| QC Level 3 | 7.596 | 240 | 0.000 | 0.002 |
| pCO2 Precision Data | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Sample | Mean (mmHg) | N | Within run SD (Sr) | Within run % CV | Total imprecision SD (St) | Total imprecision %CV |
| QC Level 1 | 58.4 | 240 | 0.58 | 1.00 | 1.33 | 2.28 |
| QC Level 2 | 41.9 | 240 | 0.06 | 0.13 | 0.53 | 1.26 |
| QC Level 3 | 23.0 | 240 | 0.07 | 0.29 | 0.42 | 1.83 |
| pO2 Precision Data | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Sample | Mean (mmHg) | N | Within run SD (Sr) | Within run % CV | Total imprecision SD (St) | Total imprecision %CV |
| QC Level 1 | 70.2 | 240 | 0.84 | 1.19 | 2.02 | 2.88 |
| QC Level 2 | 110.1 | 240 | 0.55 | 0.50 | 1.16 | 1.05 |
| QC Level 3 | 143.8 | 240 | 0.39 | 0.27 | 1.21 | 0.84 |
| Hct Precision Data | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Sample | Mean (%) | N | Within run SD (Sr) | Within run % CV | Total imprecision SD (St) | Total imprecision %CV |
| QC Level 1 | 37.9 | 240 | 0.44 | 1.15 | 0.81 | 2.15 |
| QC Level 2 | 55.0 | 240 | 0.20 | 0.37 | 0.32 | 0.58 |
| QC Level 3 | 68.6 | 240 | 0.18 | 0.26 | 0.43 | 0.63 |

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| Na Precision Data | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Sample | Mean (mmol/L) | N | Within run SD (Sr) | Within run % CV | Total imprecision SD (St) | Total imprecision % CV |
| QC Level 1 | 158.3 | 240 | 0.56 | 0.35 | 0.68 | 0.43 |
| QC Level 2 | 140.1 | 240 | 0.12 | 0.09 | 0.25 | 0.18 |
| QC Level 3 | 120.2 | 240 | 0.08 | 0.07 | 0.18 | 0.15 |
| K Precision Data | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Sample | Mean (mmol/L) | N | Within run SD (Sr) | Within run % CV | Total imprecision SD (St) | Total imprecision % CV |
| QC Level 1 | 5.81 | 240 | 0.020 | 0.34 | 0.03 | 0.48 |
| QC Level 2 | 3.81 | 240 | 0.005 | 0.14 | 0.01 | 0.36 |
| QC Level 3 | 1.87 | 240 | 0.002 | 0.13 | 0.02 | 0.97 |
| iCa Precision Data | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Sample | Mean (mmol/L) | N | Within run SD (Sr) | Within run % CV | Total imprecision SD (St) | Total imprecision % CV |
| QC Level 1 | 1.51 | 240 | 0.007 | 0.45 | 0.02 | 1.13 |
| QC Level 2 | 0.97 | 240 | 0.002 | 0.22 | 0.00 | 0.43 |
| QC Level 3 | 0.53 | 240 | 0.001 | 0.23 | 0.01 | 1.85 |
| Cl Precision Data | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Sample | Mean (mmol/L) | N | Within run SD (Sr) | Within run % CV | Total imprecision SD (St) | Total imprecision % CV |
| QC Level 1 | 131.5 | 240 | 0.57 | 0.43 | 2.30 | 1.75 |
| QC Level 2 | 103.0 | 240 | 0.72 | 0.70 | 1.52 | 1.48 |
| QC Level 3 | 86.1 | 240 | 0.27 | 0.32 | 1.38 | 1.60 |

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16

| Glucose Precision Data | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Sample | Mean (mg/dL) | N | Within run SD (Sr) | Within run % CV | Total imprecision SD (St) | Total imprecision % CV |
| QC Level 1 | 71.3 | 240 | 1.28 | 1.79 | 1.69 | 2.37 |
| QC Level 2 | 196.9 | 240 | 0.81 | 0.41 | 1.33 | 0.67 |
| QC Level 3 | 318.6 | 240 | 2.32 | 0.73 | 3.31 | 1.04 |

## Whole Blood Run-to-Run Precision Performance

Estimates of the whole blood run-to-run precision were evaluated in syringe mode and capillary mode using lithium heparinized whole blood samples. For each run, tonometered whole blood was analyzed in triplicate on 3 Stat Profile Prime analyzers over 10 separate runs for a total of 30 results per analyzer. Statistical analysis for each analyzer for both syringe mode and capillary mode was calculated.

## Run-to-Run Precision Summary - Whole Blood - syringe

| Run-to-Run Precision | | |
| --- | --- | --- |
| Parameter | n = 30 | Analyzer # 1 |
| pH | Mean | 7.406 |
| pH units | SD | 0.006 |
| PCO2 | Mean | 43.7 |
| mmHg | SD | 1.4 |
| | CV% | 3.1 |
| PO2 | Mean | 27.6 |
| mmHg | SD | 0.5 |
| | CV% | 1.9 |
| Hct | Mean | 48 |
| % | SD | 0.7 |
| | CV% | 1.46 |
| Na | Mean | 140.2 |
| mmol/L | SD | 0.4 |
| | CV% | 0.3 |
| K | Mean | 4.15 |
| mmol/L | SD | 0.03 |
| | CV% | 0.80 |

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| Run-to-Run Precision | | |
| --- | --- | --- |
| Parameter | n = 30 | Analyzer # 1 |
| iCa | Mean | 1.22 |
| mmol/L | SD | 0.01 |
| | CV% | 0.60 |
| Cl | Mean | 107.5 |
| mmol/L | SD | 0.3 |
| | CV% | 0.3 |
| Glu | Mean | 106 |
| mg/dL | SD | 3.1 |
| | CV% | 2.9 |

Run-to-Run Precision Summary -Whole Blood - capillary

| Run-to-Run Precision | | |
| --- | --- | --- |
| Parameter | n = 30 | Analyzer # 1 |
| pH | Mean | 7.385 |
| pH units | SD | 0.010 |
| pCO2 | Mean | 32.5 |
| mmHg | SD | 0.8 |
| | CV% | 2.5 |
| pO2 | Mean | 97.8 |
| mmHg | SD | 1.3 |
| | CV% | 1.4 |
| Hct | Mean | 49 |
| % | SD | 1.3 |
| | CV% | 2.65 |
| Na | Mean | 144.0 |
| mmol/L | SD | 0.8 |
| | CV% | 0.6 |
| K | Mean | 4.15 |
| mmol/L | SD | 0.02 |
| | CV% | 0.58 |
| iCa | Mean | 1.12 |
| mmol/L | SD | 0.01 |
| | CV% | 1.11 |

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| Run-to-Run Precision | | |
| --- | --- | --- |
| Parameter | n = 30 | Analyzer # 1 |
| Cl | Mean | 110.5 |
| mmol/L | SD | 0.3 |
| | CV% | 0.3 |
| Glu | Mean | 82 |
| mg/dL | SD | 2.5 |
| | CV% | 3.0 |

b. Linearity/assay reportable range:

A linearity study was performed using lithium heparin whole blood samples. For each parameter, 10 – 14 levels were prepared by tonometering, spiking or diluting whole blood to span the analytical measurement range for each parameter. Each blood level was analyzed in triplicate on each of the three Stat Profile Prime CCS analyzers and on the predicate, the pHOx Ultra analyzers. The pHOx Ultra analyzers were used to establish the target value of each blood level for each parameter. Results of linear regression using one representative analyzer are presented in the below table.

Stat Profile Prime Whole Blood Linearity

| Parameter | total # levels | Sample range | Claimed measuring range | Slope | Intercept | r |
| --- | --- | --- | --- | --- | --- | --- |
| pH | 12 | 6.542 - 8.060 pH units | 6.5-8.0 pH units | 0.9968 | 0.0295 | 0.9998 |
| pCO2 | 14 | 0.6 - 220.1 mmHg | 3.0-200 mmHg | 1.0115 | 0.3674 | 0.9993 |
| pO2 | 11 | 5.0 - 767.6 mmHg | 5.0-765 mmHg | 0.9809 | -0.1638 | 0.9992 |
| Hct | 13 | 8 – 70% | 12%-70% | 1.0073 | -1.2711 | 0.9991 |
| Na | 11 | 63.2 – 200.0 mmol/L | 80-200 mmol/L | 1.0125 | -1.1031 | 0.9998 |
| K | 11 | 0.85 - 21.9 mmol/L | 1.0-20.0 mmol/L | 1.0021 | 0.0595 | 0.9999 |

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| iCa | 13 | 0.17 - 3.06 mmol/L | 0.20-2.70 mmol/L | 1.0146 | 0.0105 | 0.9993 |
| --- | --- | --- | --- | --- | --- | --- |
| Cl | 10 | 44.3 - 221.6 mmol/L | 50-200 mmol/L | 1.0160 | 0.0024 | 0.9994 |
| Glu | 11 | 8 – 520 mg/dL | 15-500 mg/dL | 1.0211 | -1.5856 | 0.9995 |

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Traceability

pH

The pH standards and reagents used for Nova’s products are traceable to NIST primary pH reference material SRM 2186I and 2186II. Nova’s standards and reagents are measured versus the NIST primary pH buffers using a pH glass electrode and a flowing 2M KC1 Ag/AgCl reference electrode. The measurement is done at 37°C.

PCO2/PO2 Gases

Nova’s CO2/O2 gases are gravimetrically prepared and are traceable to NIST SRM 1700a, (PCO2) and 1702a (PCO2 and PO2)

PCO2/PO2 Reagents

Nova’s PCO2/PO2 controls and reagents are measured against Nova’s CO2/O2 gases traceable to NIST SRMs. The Severinghaus PCO2 electrode is used to measure these reagents versus the Nova CO2/O2 gases. These reagents are stored either in a glass ampoule or a gas-impermeable laminated foil pouch.

Na+

The reagents and standards containing sodium ion are derived from analytical reagent grade sodium chloride. This reagent is then validated using NIST SRM 2201. The validation is accomplished by using a sodium glass electrode with a 2M KC1 flowing reference electrode or a Na/K/Li flame photometer.

K+

The reagents and standards containing potassium ion are derived from analytical reagent grade potassium chloride. This reagent is then validated using NIST SRM 2202. The validation is accomplished by using a valinomycin potassium electrode

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with a 2M KC1 flowing reference electrode or a Na/K/Li flame photometer.

## Cl-

The reagents and standards containing chloride ion are derived from analytical grade sodium chloride. The reagent is then validated using NIST SRM 2201. The validation is accomplished by using a Nova analyzer employing a neutral carrier membrane electrode with a 2 M KC1 flowing reference electrode.

## Ca++

The reagents and standards containing calcium ion are derived from analytical reagent grade calcium carbonate. The reagent is then validated using NIST SRM 915a. The validation is accomplished by using a Nova analyzer employing a neutral carrier membrane electrode with a 2 M KC1 flowing reference electrode.

## Glucose

Reagents containing Glucose are traceable to NIST SRM 917a. Nova Biomedical Glucose standards and reagents are measured versus the NIST primary reference using a membrane covered Amperometric electrode at 37°C.

## Hct

Traceable to a commercially available reference method, which is a microhematocrit method.

## Shelf-life Stability

The real time stability study protocol and acceptance criteria was reviewed and found acceptable. The results support 18 month of shelf life for the Stat Profile Prime Calibrator Cartridge CCS, Stat Profile Prime Auto QC Cartridge CCS, Stat Profile Prime Ampuled Control ABG/CCS, when stored at 2-8°C.

Nova 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 (K110648). The packaging and formulation are unchanged.

## On-board stability

Real time stability study support up to 300 quality control tests for the Stat Profile prime CCS Auto-QC Cartridge; and up to 600 tests for the Stat Profile prime CCS Auto-calibrator Cartridge.

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# Value assignment:

The Stat Profile Prime Calibrator Cartridge CCS (Calibrators)-

Values are assigned by analyzing 12 samples from the test lot and 6 samples from the reference lot on three calibrated analyzers. Each sample was assayed in triplicate. The calculated calibrator value=reference lot assigned value+ (test lot mean-reference lot mean).

The Stat Profile Prime Auto QC Cartridge CCS and Stat Profile Prime Ampuled Control ABG/CCS (Controls)-

Values are assigned by analyzing 8 samples from the test lot and 8 samples of the reference lot over 2 days on two calibrated analyzers. Each sample was assayed in triplicate. The calculated control value=reference lot assigned value+ (test lot mean-reference lot mean).

## d. Detection limit:

Refer to the linearity study data above in M. 2.b. for the measuring range claim of all analytes. In addition, the sponsor conducted a Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ) for iCa, and Glucose according to the CLSI EP-17A guideline using whole blood samples.

Limit of Blank (LoB) – 100 replicates of zero level samples were measured on multiple test analyzers.

Limit of Detection (LoD) – Three blood samples with low analyte concentration were measured in 100 replicates each on multiple test analyzers. LoD=LoB+1.6494 SD

Limit of Quantitation (LoQ) – was defined according to the following criteria.

iCa: Lowest concentration where the absolute error (bias) is less than 0.10 mmol/L. Glucose: Lowest concentration where the absolute error (bias) is less than 5.0 mg/dL.

Summary: Detection limit for iCa and Glu

| | LoB | LoD | LoQ | Claimed Measurement Range |
| --- | --- | --- | --- | --- |
| Ca | 0.18 mmol/L | 0.20 mmol/L | 0.20 mmol/L | 0.2 - 2.7 mmol/L |
| Glu | 8.0 mg/dL | 10.4 mg/dL | 10.4 mg/dL | 15.0 - 500.0 mg/dL |

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# e. Analytical specificity:

Li-heparin whole blood samples were used in the interference study. For the initial testing, each interferent was spiked at 20 times the recommended concentration by CLSI EP-7 A2. Each sample containing interferent was evaluated against the same whole blood sample without the interferent. If interference was observed, a dose response study was performed at two analytes concentrations (low and high) to determine the highest substance concentration where no interference was observed. The sponsor's definition of significant interference is $\pm 10\%$ bias for pH, pO2, pCO2, Na, K, Ca, Cl, glucose, and Hct, +/- 0.020 for pH. The following table represents substances that were tested without demonstrating a significant interference on test results:

| Interfering Substance | Highest Concentration Tested | Analyte(s) Tested |
| --- | --- | --- |
| Acetaminophen | 20.0 mg/dL | Glu |
| Acetoacetate | 2.0 mmol/L | pH, Na, K, iCa, Cl, Glu, |
| Acetylsalicylic acid | 3.62 mmol/L | Na, K, Cl, Glu |
| Ammonium Chloride | 107.0 μmol/L | Na, K, Cl, iCa, Glu |
| Ascorbic Acid | 50 mg/dL | Cl, Glu |
| Benzylkonium Chloride | 10.0 mg/L | pH, Na, K, Cl, iCa, Glu |
| Beta-Hydroxybutyrate | 2.0 mmol/L | Glu |
| Bilirubin | 20.0 mg/dL | Hct, pH, PCO2, PO2, Na, K, Cl, iCa, Glu |
| Calcium Chloride | 2.0 mmol/L | pH, PCO2, PO2, Na, K |
| D-Galactose | 1.0 mmol/L | Glu |
| Dobutamine | 2.0 mg/dL | pH, Na, K, iCa, Glu |
| Dopamine Hydrochloride | 5.87 μmol/L | Glu |
| EDTA | 3.4 umol/L | Glu |
| Ethanol | 86.8 mmol/L | Glu, pH, PCO2, PO2 |
| Fluorescein | 1.0 mmol/L | PCO2, PO2 |
| Fluoride | 105 μmol/L | Glu |
| Fluoride | 100 μmol/L | Glu |
| Fluoride | 1000 μmol/L | Glu |

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| Interfering Substance | Highest Concentration Tested | Analyte(s) Tested |
| --- | --- | --- |
| Glycolic Acid | 1 mmol/L | Glu |
| Glucosamine | 30.0 μmol/L | Glu |
| Hemoglobin | 2.0 g/L | Hct, pH, PCO2, PO2, Na, K, Cl, iCa, Glu |
| Heparin | 100 IU/mL | Glu, Hct |
| Ibuprofen | 2.4 mmol/L | Na, K, iCa, Cl, Glu |
| Intralipid | 1000 mg/dL | Hct, pH, PCO2, PO2, Na, K, Cl, iCa, Glu |
| Lithium Lactate | 6.6 mmol/L | Na, K, iCa, Glu |
| Magnesium Chloride | 15.0 mmol/L | Na, Cl |
| Maltose | 13.0 mmol/L | Glu |
| Mannose | 1.0 mmol/L | Glu |
| Perchlorate | 1.0 mmol/L | iCa |
| Potassium Chloride | 5.0 mmol/L | pH, PCO2, PO2, iCa |
| Potassium Thiocyanate | 2,064 μmol/L | Cl, Glu |
| Pyruvate | 309 μmol/L | Glu |
| Salicylic Acid | 4.34 mmol/L | Na, K, Cl, Glu |
| Sodium Bromide | 37.5 mmol/L | pH, K, iCa |
| Sodium Chloride | 10.0 mmol/L | pH, PCO2, PO2, iCa |
| Sodium Citrate | 12.0 mmol/L | Cl, Glu |
| Sodium Oxalate | 500 mg/dL | Cl, Glu |
| Sodium Salicylate | 50.0 mg/dL | Glu |
| Xylose | 25.0 mg/dL | Glu |
| Zinc Chloride | 1.3 mg/dL | Na, K, iCa, |

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The following table represents substances that were tested that demonstrated a significant interference on test results:

| Parameter | Interfering Substance | Concentration of interfering substance | Interference |
| --- | --- | --- | --- |
| Chloride | Bromide | 2.5 mmol/L | No interference observed |
| | | 5.0 mmol/L | Bias of 12.7% |
| | Thiocyanate | 3.4 mmol/L | No interference observed |
| | | 5.1 mmol/L | Bias of 15.2% |
| Ionized Calcium | MgCl2 | 3.75 mmol/L | No interference observed |
| | | 7.50 mmol/L | Bias of 13.5% |
| Glucose | Hydroxyurea | 0.2 mg/dL | No interference observed |
| | | 0.4 mg/dL | Bias of 19.2% |
| | Oxalate | 125 mg/dL | No interference observed |
| | | 250 mg/dL | Bias of -10.9% |
| | Thiocyanate | 1.7 mmol/L | No interference observed |
| | | 3.4 mmol/L | Bias of 10.0% |
| Hct | Albumin | 2.8 g/dL | No interference observed |
| | | 5.7 g/dL | Bias of 12.7% |
| | Hemolysis | 5% | No interference observed |
| | | 10% | Bias of -10.7% |
| | Triglycerides | 986.4 mg/dL | No interference observed |
| | | 1233 mg/dL | Bias of 12.9% |

Because of the known limitations, the sponsor has the following limitation statements in the labeling:

For Potassium: Correct sample handling is critical to ensure whole blood potassium values obtained accurately reflect the in vivo state. For example, a hemolyzed specimen of 50 mg/dL hemoglobin will increase the potassium blood concentration by 3%.

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For the calculated hemoglobin: The hemoglobin calculation is an estimation based on a normal mean corpuscular hemoglobin concentration of $33.3\%$ and a nominal male Hct of 39 to $49\%$ or female Hct of 35 to $45\%$ . Hemoglobin estimations made from samples with red cell dyscrasia or hemoglobinopathies may vary significantly from hemoglobin measured by cyanmethemoglobin method. The estimated hemoglobin may vary significantly in cases of abnormal blood composition or disease states such as anemia in which abnormal values may not be reported. These conditions should warrant repeat testing by conventional laboratory methods

For hematocrit: White Blood Count (WBC) greater than 50,000 WBC/μL may increase the hematocrit value.

Burtis, Carl A. and Ashwood, Edward R., ed. 1999. Tietz Textbook of Clinical Chemistry, 3rd Edition. Philadelphia, PA: W.B. Saunders Co. p.1058.

f. Assay cut-off:

Not applicable.

# 2. Comparison studies:

a. Method comparison with predicate device:

Method comparison studies were performed internally. A minimum of 150 whole blood specimens were analyzed for each parameter in syringe collection devices. Some samples were altered in order to achieve the hard-to-find sample range. The samples were analyzed on each of the Stat Profile Prime CCS analyzers and on each of the pHOx Ultra analyzers. The Stat Profile Prime CCS results for each analyzer were compared to the average of the 2 results from the pHOx Ultra comparative method.

Syringe method comparison study results vs. the predicate device (Stat Profile pHOx Ultra)

| Test Parameter | Total # samples | Sample range tested | Slope | Intercept | r |
| --- | --- | --- | --- | --- | --- |
| pH | 172 | 6.523 - 7.862 pH units | 0.9976 | 0.0099 | 0.9985 |
| pCO2 | 179 | 3.4 - 200.0 mmHg | 0.9854 | 0.9344 | 0.9977 |
| pO2 | 167 | 29.5 - 593.2 mmHg | 0.9897 | 1.4508 | 0.9988 |
| Hct | 174 | 12 - 70% | 1.0445 | -1.9271 | 0.9889 |
| Na | 180 | 85.5 - 195.7 mmol/L | 1.0189 | -2.2841 | 0.9955 |
| K | 179 | 1.11 - 19.75 mmol/L | 1.0163 | -0.0371 | 0.9996 |
| iCa | 181 | 0.25 - 2.48 mmol/L | 0.9880 | 0.0457 | 0.9974 |

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| Test Parameter | Total # samples | Sample range tested | Slope | Intercept | r |
| --- | --- | --- | --- | --- | --- |
| Cl | 186 | 52.8 - 189.3 mmol/L | 1.0003 | 1.0158 | 0.9955 |
| Glu | 185 | 39 - 474 mg/dL | 1.0007 | -2.6844 | 0.9892 |

Whole blood patient samples were evaluated to demonstrate that syringe sample mode and capillary sample mode are equivalent. The syringe sample was analyzed directly using the syringe mode. After the measurement, samples were transferred from the syringe into the capillary tube and then analyzed using the capillary mode. Approximately 100 whole blood samples were analyzed for each parameter. The capillary test result was compared to the syringe test result and linear regression analysis was performed. Results are summarized in the table below.

| Parameter | total # samples | sample range tested | Slope | Intercept | r |
| --- | --- | --- | --- | --- | --- |
| pH | 100 | 6.787 - 7.683 | 1.0094 | -0.0721 | 0.9988 |
| pH units | | | | | |
| pCO2 | 100 | 17.7 - 111.0 | 1.0026 | -0.4347 | 0.9989 |
| mmHg | | | | | |
| pO2 | 100 | 25.5 - 435.2 | 0.9942 | 2.1791 | 0.9996 |
| mmHg | | | | | |
| Hct % | 100 | 14 - 69 | 1.0013 | 0.0485 | 0.9963 |
| Na mmol/L | 100 | 85.0 - 198.1 | 0.9995 | -0.1711 | 0.9978 |
| K mmol/L | 100 | 2.70 - 19.37 | 0.9966 | 0.0934 | 0.9996 |
| iCa mmol/L | 98 | 0.33 - 2.51 | 1.0228 | -0.0603 | 0.9855 |
| Cl mmol/L | 100 | 55.8 - 197.1 | 0.9897 | 0.1776 | 0.9997 |
| Glu mg/dL | 100 | 17 - 488 | 0.9855 | -0.4734 | 0.9998 |

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b. Matrix Comparison:

Not applicable. The only sample type acceptable for this device is lithium heparin whole blood.

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable

b. Clinical specificity:

Not applicable

c. Other clinical supportive data (when a. and b. are not applicable):

Not applicable

4. Clinical cut-off:

Not applicable.

5. Expected values/Reference range:

The sponsor has provided the following Expected Values in the Manual:

pH^{1, 2, 4}: 7.35 - 7.45

PCO2^{1, 2, 4}: 35 - 45 mmHg

PO2^{1, 2, 4}: 83 - 108 mmHg

Hematocrit (Hct)^{1, 2, 4}

(Male) 39 - 49%

(Female) 35 - 45%

Sodium^{2}: 136 - 146 mmol/L

Potassium^{2}: 3.5 - 5.1 mmol/L

Chloride^{2}: 98 - 106 mmol/L

Glucose^{2}: 65 - 95 mg/dL

Ionized Calcium^{3}: 1.09 - 1.30 mmol/L

References:

1. Statland, Bernard. 1987. Clinical Decisions Levels for Lab Tests, Medical Economics Books.

2. Burtis, Carl A. and Ashwood, Edward R., ed. 1994. Tietz Textbook of Clinical Chemistry. Philadelphia, PA: W. B. Saunders Co.

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3. Kost, G.T. 1993. The Significance of Ionized Calcium in Cardiac and Critical Care. Arch. Pathol. Lab Med. Vol. 117: pp 890-896.
4. Burtis, Carl A. Ashwood, Edward R., Burns, David R., 2011. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 5th ed, Philadelphia, PA: W. B. Saunders Co.

N. Instrument Name:

Stat Profile Prime CCS Analyzer

O. System Descriptions:

1. Modes of Operation:

Fully automated

2. Software:

FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:

Yes ☐ x ☐ or No ☐

3. Specimen Identification:

Bar code

4. Specimen Sampling and Handling:

Lithium heparinized whole blood from syringes, open tubes, small cups, and capillary tubes.

Analyzer will accept 3 sample types, namely, heparinized syringe, heparinized capillary tube, and heparinized blood collection tube (open tube). In addition, small cups (for quality control testing) will also be acceptable.

5. Calibration:

The Stat Profile Prime CCS analyzer performs a 2-point calibration 30 minutes after being powered on and regularly thereafter to maintain optimal micro sensor card and air detector performance. A 1-point calibration is performed at regular intervals to monitor the Micro Sensor Card’s performance between each 2-point calibration. A manually initiated 2-point calibration can be performed whenever the analyzer displays Ready or Not Ready on the header bar. A Not Ready (Not Calibrated) status is displayed after powering the analyzer on, after replacing some consumable items or as a result of a system error.

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6. Quality Control:

QC consists of the following materials:

Stat Profile Prime Auto QC Cartridge CCS (on-board internal control), and Stat Profile Prime Ampuled Control ABG/CCS (external control, same composition as the on-board internal control)

Nova Linearity Standard Set A

User should follow federal, state and local guidelines for testing quality control materials.

P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:

Not Applicable

Q. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10, and 21 CFR 801.109(b)(1) to indicate For In Vitro Diagnostic Use and Prescription use Only.

R. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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