EPOC BLOOD ANALYSIS SYSTEM

K061597 · Epocal, Inc. · JGS · Sep 27, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061597
• Device Name: EPOC BLOOD ANALYSIS SYSTEM
• Applicant: Epocal, Inc.
• Product Code: JGS · Clinical Chemistry
• Decision Date: Sep 27, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1665
• Device Class: Class 2

Intended Use

The EPOC Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of whole blood in the laboratory or at the point of care in hospitals, nursing homes or other clinical care institutions. The Blood Gas Electrolyte (BGE) test card panel configuration includes sensors for Sodium - Na, Potassium - K, ionized Calcium - iCa, pH, pCO2, pO2 and Hematocrit - Hct. Measurement of Sodium and Potassium are used in diagnosis and treatment diseases involving electrolyte imbalance. Measurement of Ionized Calcium is used in diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. Measurement of pH pCO2, pO2 (blood gases) is used in the diagnosis and treatment of life-threatening acid-base disturbances. Measurement Hct distinguish normal from abnormal states of blood volume, such as anemia and erythrocytosis.

Device Story

System comprises single-use test card, card reader, and PDA host. Card contains sensor array (potentiometric, amperometric, conductimetric) and sealed calibrator reservoir. User introduces whole blood sample into card; reader heats card to 37°C, performs mechanical engagement to rupture calibrator, and digitizes raw sensor signals. Reader transmits data via Bluetooth to PDA host. Host software processes signals, calculates analytical values, and displays results. Used in clinical settings by trained professionals (nurses, RTs, assistants) for rapid point-of-care diagnostics. Output enables immediate clinical decision-making for critical care patients.

Clinical Evidence

Clinical performance was evaluated via method comparison studies at hospital point-of-care sites (ICU, cardiac ICU, hematology/oncology, central lab). 142-156 patient samples (arterial, venous, mixed) were tested against the i-STAT predicate. Results showed high correlation (R=0.953-0.993) across all parameters (pH, pCO2, pO2, K, Na, iCa, Hct). Precision studies (20-day in-house and field trials with 7 operators) demonstrated acceptable CVs. Bench testing confirmed linearity (R2=0.998-0.999) and analytical specificity against various endogenous and exogenous interferences.

Technological Characteristics

System uses electrochemical multi-sensor array (PVC ion-selective electrodes for pH, Na, K, iCa; Severinghaus-type for pCO2; membrane-coated gold cathode for pO2; conductivity for Hct). Reader includes thermal subsystem (37°C), Bluetooth connectivity, and PDA host. Operates on unit-use test cards with on-board calibrator. Software performs signal processing and calculation of analytical values.

Indications for Use

Indicated for trained medical professionals to perform quantitative whole blood testing in labs, hospitals, nursing homes, or clinical institutions. Used for diagnosing/treating electrolyte imbalances, parathyroid/bone/renal diseases, tetany, acid-base disturbances, anemia, and erythrocytosis.

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

• i-Stat™ Model 300 Portable Clinical Analyzer (K001387)

Submission Summary (Full Text)

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## APPENDIX 9

K061597

# e pocal

SEP 27 2006

2935 Conroy Road Ottawa Ontario, Canada K1G 6C6

# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

Summary Prepared: June 7, 2006

| Submitted by: | Epocal Inc. |
|---------------|-------------------------------------------------------------------------------------------------------|
| | 2935 Conroy Road, Ottawa, Ontario, Canada K1G 6C6<br>Telephone: [phone]<br>Fax: [phone] |

Contact: Roy Layer Director of Quality Assurance and Regulatory Affairs.

#### Identification of the Device 5.1

| Device Name: | EPOC™ Blood Analysis System |
|---------------------------|-----------------------------|
| Proprietary / Trade Name: | EPOC Blood Analysis System |
| Common Name: | Portable Blood Analyzer |
| Classification Name: | See Tables Below |
| Device Classification: | See Tables Below |
| Regulation Number: | See Tables Below |
| Panel: | See Tables Below |
| Product Code: | See Tables Below |

| Name | Class | Regulation<br>Number | Panel | Product<br>Code |
|-----------------------------------------------------------------|-------|----------------------|-----------------------|-----------------|
| Electrode, Ion Specific, Sodium | II | 862.1665 | Clinical<br>Chemistry | JGS |
| Electrode, Ion Specific, Potassium | II | 862.1600 | Clinical<br>Chemistry | CEM |
| Hematocrit | II | 864.6400 | Hematology | JPI |
| Electrode, Ion Specific, Calcium | II | 862.1145 | Clinical<br>Chemistry | JFP |
| Electrode Measurement, Blood-<br>Gases (PCO2, PO2) and Blood pH | II | 862.1120 | Clinical<br>Chemistry | CHL |

Figure 5.1 – Table - EPOC™ Blood Analysis System with Blood Gas Electrolyte (BGE) Test Card

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#### 5.2 Identification of the Predicate Device

i-Stat™ Model 300 Portable Clinical Analyzer

#### 5.3 Description of the New Device

The EPOC system is a new device that has never been marketed in the United States of America. There are no previous related 510k submissions for this device.

The EPOC Blood Analysis System consists of three (3) components:

- 1. EPOC Test Card
The single use blood test card comprises a port for introduction of a blood sample to an array of sensors on a sensor module. The sensor module is mounted proximal to a fluidic channel contained in a credit-card sized housing. The card has an on-board calibrator contained in a sealed reservoir fluidically connected to the senor array through a valve.

- 2. EPOC Card Reader
The reader is a minimally featured raw-signal acquisition peripheral. The reader comprises a card orifice for accepting a test card, and a mechanical actuation assembly for engaging the test card after it is inserted into the card orifice. Within the reader's card orifice there is a bar code scanner, an electrical contact array for contacting the card's sensor module, and a thermal subsystem for heating the card's measurement region to 37°C during the test. The reader also comprises circuits for amplifying, digitizing and converting the raw sensor signals to a wireless transmittable Bluetooth™ format,

- 3. EPOC Host
The host is a dedicated use Personal Digital Assistant (PDA) computing device with custom software that displays the test results. The reader and host computer together constitute all of the subsystems generally found in a traditional analyzer that operates on unit-use sensors and reagents

#### 5.4 Intended Use of the Device

The EPOC Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of whole blood in the laboratory or at the point of care in hospitals, nursing homes or other clinical care institutions.

The BGE test card panel configuration includes sensors for Sodium Na, Potassium K, Ionized Calcium iCa, pH, pCO2, pO2 and Hematocrit Hct.

Measurement of sodium and potassium are used in diagnosis and treatment of diseases involving electrolyte imbalance. Measurement of ionized calcium ismused in diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. Measurement of pH, pCO2 and pO2 (blood gases) is used in the diagnosis and treatment of life-threatening acid-base disturbances. Maasurement of hematocrit distinguishes normal from abnormal states of blood red cell volume, such as in anemia and erythrocytosis

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| | EPOC Blood Analysis System | | | | i-STAT Model 300<br>K001387 | | Same /<br>Different |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|----------|-----------------------------------------------------------|
| 510(k) #<br>Item | Device | | | Predicate | | | |
| Intended<br>use | The EPOC Blood Analysis System is<br>intended for use by trained medical<br>professionals as an in vitro diagnostic<br>device for the quantitative testing of<br>samples of whole blood using the BGE<br>(Blood Gas Electrolyte) and ABG<br>(Arterial Blood Gas) test card panels. | | | The i-STAT Model 300 Portable Clinical<br>Analyzer is intended to be used by<br>trained medical professionals for use<br>with i-STAT test cartridges and<br>MediSense blood glucose test strips.<br>i-STAT cartridges comprise a variety<br>of clinical chemistry tests and test<br>panels. | | | same |
| Where used | hospital | | | hospital | | | same |
| Measured<br>parameters | pH, pCO2, pO2, Na, K, iCa, Hct | | | pH, pCO2, pO2, Na, K, iCa, Hct | | | same |
| Calculated<br>parameters | TCO2, HCO3, BE, SO2, Hgb | | | TCO2, HCO3, BE, SO2, Hgb | | | same |
| Sample type | Venous, arterial whole blood | | | Venous, arterial and skin puncture<br>whole blood | | | same |
| Reportable<br>ranges | pH | 6.5 - 8.0 | pH units | pH | 6.5 - 8.2 | pH units | different |
| | pCO2 | 5 - 250 | mm Hg | pCO2 | 5 - 130 | mm Hg | different |
| | pO2 | 5 - 750 | mm Hg | pO2 | 5 - 800 | mm Hg | same |
| | Na | 85 - 180 | mmol/L | Na | 100 - 180 | mmol/L | different |
| | K | 1.5 - 12 | mmol/L | K | 2.0 - 9.0 | mmol/L | different |
| | iCa | 0.25 - 4 | mmol/L | iCa | 0.25 - 2.5 | mmol/L | different |
| | Hct | 10 - 75 | %PCV | Hct | 10 - 75 | %PCV | same |
| | TCO2 | 1 - 85 | mmol/L | TCO2 | 5 - 50 | mmol/L | different |
| | HCO3 | 1 - 85 | mmol/L | HCO3 | 1 - 85 | mmol/L | same |
| | BEecf | -30 - +30 | mmol/L | BEecf | -30 - +30 | mmol/L | same |
| | BEb | -30 - +30 | mmol/L | BEb | -30 - +30 | mmol/L | same |
| | SO2 | 0 - 100 | % | SO2 | 0 - 100 | % | same |
| | Hb | 3.3 - 25 | g/dL | Hb | 3 - 26 | g/dL | same |
| Sample<br>volume | 95-125 μL | | | 100μL | | | same |
| Test card | Unit-use card with<br>- on-board calibrator in sealed<br>reservoir<br>- an electrochemical multi-sensor<br>array<br>- port for sample introduction<br>- fluid waste chamber | | | Unit-use cartridge with<br>- on-board calibrator in sealed<br>reservoir<br>- an electrochemical multi-sensor<br>array<br>- port for sample introduction<br>- fluid waste chamber | | | same |
| Test card<br>storage | Room temperature until expiry date | | | Fridge storage until expiry date<br>including max 2 weeks at room<br>temperature | | | different |
| Sensor array<br>Tests/sensor<br>components | A laminated foil sensor module<br>pH - PVC ion selective electrode<br>pCO2 - QH modified Severinghaus<br>type<br>pO2 - membrane coated gold cathode<br>Na - PVC ion selective electrode<br>K - PVC ion selective electrode<br>iCa - PVC ion selective electrode<br>Hct - conductivity, gold electrodes | | | A micro-fabricated chip-set<br>pH - PVC ion selective electrode<br>pCO2 - QH modified Severinghaus<br>type<br>pO2 - membrane coated gold cathode<br>Na - PVC ion selective electrode<br>K - PVC ion selective electrode<br>iCa - PVC ion selective electrode<br>Hct - conductivity, gold electrodes | | | different<br>same<br>same<br>same<br>same<br>same<br>same |
| Analyzer<br>components | Two housings:<br>1 - The reader comprising<br>- Orifice for test card introduction<br>- electrical connector to card<br>- heater for 37°C operation<br>- mechanical card engagement<br>device for | | | A single housing comprising<br>- Orifice for test card introduction<br>- electrical connector to card<br>- heater for 37°C operation<br>- mechanical card engagement<br>device for | | | different<br>same<br>same<br>same |

## Comparison of Technological Characteristics To Predicate 5.5 Device

Epocal EPOC System 510(k) Submission Appendix 9

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| | making electrical contact to card's sensors for rupture of calibrator reservoir moving calibrator to sensors engaging heaters with card -<br>op-amp sensor signal detectors<br>IQC monitoring devices<br>Thermal controllers<br>MUX<br>A/D<br>Bluetooth stack for wireless transmission of digitized raw sensor signals to computing device<br>bar code scanner for acquiring card info<br>internal electronic reader self-test circuit<br>2 - The computing device comprising a PDA<br>microprocessor<br>memory<br>color LCD display<br>keyboard<br>i/o for communicating test results to other devices<br>software to control the test and calculate analytical values from raw sensor signals<br>battery operated with rechargeable batteries via plug in plug-in power supply | making electrical contact to card's sensors for rupture of calibrator reservoir moving calibrator to sensors engaging heaters with card -<br>op-amp sensor signal detectors<br>IQC monitoring devices<br>Thermal controllers<br>MUX<br>A/D<br>wire transmission of digitized raw sensor signals to computing subsystem in same housing<br>n/a<br>internal and external electronic reader self-test circuit<br>microprocessor<br>memory<br>monochrome LCD display<br>keyboard<br>i/o for communicating test results to other devices<br>software to control the test and calculate analytical values from raw sensor signals<br>battery operated with rechargeable batteries via external power supply in downloader cradle | same<br>same<br>same<br>same<br>same<br>same<br>same<br>same<br>different<br>different<br>different<br>same<br>same<br>different<br>same<br>same<br>same |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Measurement<br>temperature | 37°C | 37°C | same |
| Measurement<br>sequence | Calibrate test card-introduce sample- measure | Introduce sample-calibrate test cartridge-measure | different |
| Measurement<br>time | 30sec from sample introduction | 200 sec from sample introduction | different |
| Error<br>detection | iQC system to detect user errors<br>IQC system for reader self-check<br>IQC system to detect card non- conformance | iQC system to detect user errors<br>IQC system for reader self-check<br>IQC system to detect card non- conformance | same<br>same<br>same |

## Figure 5.2 – Table Comparing EPOC Device Performance Characteristics With Predicate Device

The EPOC System has the same intended use and utilizes the same test methodologies as the predicate device. Most of the system components are very similar to the predicate device. Differences between the EPOC device and the predicate device have no significant effect on the safety or effectiveness of the system.

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## Summary of Non-Clinical Test Performance in Support of 5.6 Substantial Equivalence

#### Precision 5.6.1

Experiments were performed in-house to demonstrate the precision of the EPOC test methods. The table below shows the results of a twenty day precision study using aqueous controls at two levels L1 and L3 for the blood gases and electrolytes, and two levels of aqueous controls for Hematocrit, level A, level B.

| | | L1 | | | | | | |
|-------|-------|-------|-------|-------|-------|-------|-------|--|
| | pH | pCO2 | pO2 | Na | K | iCa | Hct | |
| Mean | 6.986 | 80.6 | 78.4 | 114.5 | 2.15 | 2.2 | -16.9 | |
| SWR | 0.006 | 1.94 | 1.94 | 0.57 | 0.021 | 0.023 | 0.35 | |
| %CVWR | 0.09% | 2.40% | 2.47% | 0.50% | 0.97% | 1.02% | | |
| SDD | 0.004 | 1.31 | 1.96 | 0.67 | 0.011 | 0.017 | 0.42 | |
| %CVDD | 0.05% | 1.63% | 2.50% | 0.59% | 0.51% | 0.76% | | |
| ST | 0.008 | 2.36 | 2.57 | 0.80 | 0.025 | 0.028 | 0.49 | |
| %CVT | 0.11% | 2.92% | 3.28% | 0.70% | 1.15% | 1.26% | | |
| | L3 | | | | | | | |
| | pH | pCO2 | pO2 | Na | K | iCa | Hct | |
| Mean | 7.676 | 22.5 | 141.2 | 153.2 | 6.58 | 0.67 | -14.5 | |
| SWR | 0.005 | 0.36 | 1.78 | 0.71 | 0.053 | 0.009 | 0.36 | |
| %CVWR | 0.06% | 1.61% | 1.26% | 0.47% | 0.80% | 1.29% | | |
| SDD | 0.004 | 0.55 | 1.44 | 0.77 | 0.037 | 0.010 | 0.33 | |
| %CVDD | 0.05% | 2.44% | 1.02% | 0.50% | 0.56% | 1.43% | | |
| ST | 0.006 | 0.56 | 2.24 | 0.97 | 0.064 | 0.012 | 0.46 | |
| %CVT | 0.08% | 2.50% | 1.58% | 0.63% | 0.98% | 1.77% | | |

| | Level A | Level B |
|------|---------|---------|
| | Hct | Hct |
| Mean | 25.3 | 46.1 |
| SWR | 0.370 | 0.68 |
| %CVT | 1.46% | 1.48% |
| SDD | 0.160 | 0.00 |
| %CVT | 0.63% | 0.00% |
| ST | 0.400 | 0.68 |
| %CVT | 1.58% | 1.48% |

Figure 5.3A – Table – 20 Day Precision Study Data

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Experiments were performed at three point of care sites with 7 point of care operators performing n=10 replicates on whole blood

In field trials, 10 replicates of different whole blood patient samples were run by different operators of the EPOC system at different point-of-care sites. Each precision study employed 5 different EPOC readers.

| Na | | mean | SD | % CV |
|--------------|-------------------|-------|-------|------|
| Site 1 | operator 1 | 142 | 0.5 | 0.3 |
| | operator 2 | 143 | 1.5 | 1.0 |
| Site 2 | operator 3 | 142 | 1.2 | 0.8 |
| | operator 4 | 143 | 0.8 | 0.6 |
| | operator 5 | 143 | 0.7 | 0.5 |
| Site 3 | operator 6 | 141 | 0.7 | 0.5 |
| | operator 7 | 140 | 1.0 | 0.7 |
| K | | mean | SD | % CV |
| Site 1 | operator 1 | 4.0 | 0.05 | 1.3 |
| | operator 2 | 4.0 | 0.00 | 0.0 |
| Site 2 | operator 3 | 3.7 | 0.00 | 0.0 |
| | operator 4 | 3.8 | 0.03 | 0.8 |
| | operator 5 | 3.7 | 0.03 | 0.9 |
| Site 3 | operator 6 | 3.6 | 0.03 | 0.9 |
| | operator 7 | 4.1 | 0.05 | 1.2 |
| iCa | | mean | SD | % CV |
| Site 1 | operator 1 | 1.20 | 0.02 | 1.5 |
| | operator 2 | 1.21 | 0.02 | 1.9 |
| Site 2 | operator 3 | 1.19 | 0.02 | 1.7 |
| | operator 4 | 1.21 | 0.03 | 2.1 |
| | operator 5 | 1.20 | 0.02 | 1.6 |
| Site 3 | operator 6 | 1.23 | 0.02 | 1.8 |
| | operator 7 | 1.24 | 0.02 | 1.9 |
| Hct | | mean | SD | % CV |
| Site 1 | operator 1 | 40 | 0.6 | 1.4 |
| | operator 2 | 40 | 0.5 | 1.3 |
| Site 2 | operator 3 | 39 | 0.6 | 1.6 |
| | operator 4 | 41 | 0.5 | 1.2 |
| | operator 5 | 40 | 0.6 | 1.4 |
| Site 3 | operator 6 | 40 | 0.8 | 2.0 |
| | operator 7 | 38 | 0.7 | 1.9 |
| pH | | mean | SD | % CV |
| Site 1 | operator 1 | 7.365 | 0.006 | 0.08 |
| | operator 2 | 7.368 | 0.005 | 0.07 |
| Site 2 | operator 3 | 7.322 | 0.005 | 0.07 |
| | operator 4 | 7.335 | 0.006 | 0.08 |
| | operator 5 | 7.303 | 0.009 | 0.12 |
| Site 3 | operator 6 | 7.266 | 0.006 | 0.08 |
| | operator 7 | 7.381 | 0.004 | 0.05 |
| <i>p</i> CO2 | | mean | SD | % CV |
| | Site 1 operator 1 | 52.3 | 2.0 | 3.8 |
| | operator 2 | 49.9 | 0.9 | 1.9 |
| | Site 2 operator 3 | 56.9 | 0.9 | 1.5 |
| | operator 4 | 55.4 | 1.4 | 2.5 |
| | operator 5 | 58.9 | 1.1 | 1.9 |
| | Site 3 operator 6 | 61.7 | 1.8 | 2.9 |
| | operator 7 | 41.5 | 0.9 | 2.1 |
| <i>p</i> O2 | | mean | SD | % CV |
| | Site 1 operator 1 | 28.6 | 1.7 | 6.0 |
| | operator 2 | 32.9 | 1.8 | 5.5 |
| | Site 2 operator 3 | 33.9 | 1.2 | 3.5 |
| | operator 4 | 30.0 | 1.5 | 5.0 |
| | operator 5 | 40.1 | 1.2 | 3.1 |
| | Site 3 operator 6 | 61.8 | 3.5 | 5.6 |

Epocal EPOC System 510(k) Submission Appendix 9

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Figure 5.3B Field trial whole blood precision at point of care sites

#### 5.6.2 Linearity/Reportable Range

74.6

2.9

This study was performed in-house to demonstrate linearity on whole blood versus an in-house standard method with traceability to NIST standards.

3.9

| | Test range | Units | Slope | Intercept | R2 |
|------|------------|----------|-------|-----------|-------|
| pH | 6.4-7.9 | pH units | 1.021 | -0.15 | 0.998 |
| pCO2 | 10-230 | mm Hg | 1.058 | -3.6 | 0.998 |
| pO2 | 10-750 | mm Hg | 1.022 | -3.9 | 0.999 |
| K | 1.5-12 | mmol/L | 1.006 | 0.03 | 0.999 |
| Na | 80-190 | mmol/L | 0.973 | 3.8 | 0.999 |
| iCa | 0.6-3.7 | mmol/L | 1.017 | -0.01 | 0.998 |
| Hct | 0-75 | % PCV | 1.005 | -0.58 | 0.999 |

Figure 5.4 – Table - In House Whole Blood Linearity

#### 5.6.3 Traceability

operator 7

The EPOC System is calibrated is against methods traceable to NIST standards.

The EPOC System's test card comprises an on-board calibration material, prepared gravimetrically and assayed on reference systems calibrated with traceability to WITST standards.

Calibration verification uses commercially available calibration verification fluids whose concentration values are traceable to NIST standards.

Quality control materials are commercially available fluids with concentrations traceable to NIST standards.

#### 5.6.4 Detection Limit

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Detection limits for the EPOC measurements are those determined by the limits of the reportable range.

#### 5.6.5 Analytical Specificity

The following tables summarize data from interference studies performed on the EPOC device. The data are presented as interference bias (test result minus control) expressed as a fraction of TE, the total allowable error (or as a % bias where indicated).

| Exogenous<br>Interference | Level | Mean(Test result - blank control)/TE | | | | | | |
|---------------------------|-------------|--------------------------------------|---------|--------|------|------|------|------|
| | | pH | $pCO_2$ | $pO_2$ | K | Na | iCa | Hct |
| Ethanol | 447 mg/dL | -0.4 | -0.2 | 0.0 | +0.1 | +0.1 | 0.0 | +0.3 |
| Sodium pentothal | 1 mmol/L | 0.0 | +0.1 | -0.2 | +0.1 | +0.2 | -0.4 | +0.1 |
| Acetyl salicylate | 4.3 mmol/L | 0.0 | -0.1 | -0.1 | 0.0 | 0.0 | -0.4 | +0.2 |
| Ascorbate | 0.4 mmol/L | +0.1 | -0.3 | +0.2 | 0.0 | 0.0 | 0.0 | +0.1 |
| Salycilate | 4.3 mmol/L | +0.3 | 0.0 | -0.2 | +0.1 | 0.0 | -0.4 | -0.1 |
| Bromide | 18 mmol/L | -0.6 | +7% | +0.3 | +0.1 | +0.3 | +0.3 | -0.3 |
| Bromide | 37.5 mmol/L | -1.2 | +13% | +0.0 | +0.2 | +0.6 | +0.9 | X |
| Iodide | 1 mmol/L | -0.5 | 5% | -0.1 | +0.0 | +0.1 | +0.3 | -0.1 |
| Iodide | 3 mmol/L | -1.2 | 11% | -0.2 | +0.2 | +0.0 | +0.3 | X |
| Ibuprofen | 2.2 mmol/L | -0.3 | +0.1 | -0.1 | 0.0 | -0.1 | -0.3 | +0.1 |
| Tylenol | 1.66 mmol/L | 0.0 | -0.1 | 0.0 | 0.0 | 0.0 | 0.0 | X |
| Ammonium | 2 mmol/L | +0.1 | -0.2 | -0.1 | 0.0 | 0.0 | -0.1 | X |
| Lithium | 4 mmol/L | -0.1 | -0.1 | 0.0 | +0.1 | 0.0 | +0.1 | -0.1 |
| Halothane | 2.7% | X | X | 0.0 | X | X | X | X |

Figure 5.5 – Table Of Interference Test Data Expressed As Fraction Of Total Allowable Error (TE); Exogenous Interferences

| Endogenous<br>interference | Level | Mean(Test result - blank control)/TE | | | | | | |
|----------------------------|-------------|--------------------------------------|------|------|------|------|--------|------|
| | | pH | pCO2 | pO2 | K | Na | iCa | Hct |
| NaCl | 20 mmol/L | -0.3 | +0.1 | -0.1 | +0.1 | X | +0.1 | X |
| KCl | 8 mmol/L | +0.2 | 0.0 | 0.0 | X | +0.1 | -0.4 | X |
| CaCl2 | 3 mmol/L | +0.1 | +0.3 | -0.3 | +0.1 | +0.4 | X | X |
| pH | +/-0.4 pH | X | X | 0.0 | 0.0 | +0.1 | -/+0.3 | X |
| pCO2 | -/+60 mm Hg | | | | | | | |
| Bicarbonate | 20 mmol/L | +0.5 | +0.3 | -0.3 | 0.1 | +0.1 | +0.1 | X |
| Lactate | 10 mmol/L | +0.2 | +0.1 | +0.0 | -0.1 | -0.3 | -0.3 | X |
| Hct | +20% PCV | | -0.1 | +0.1 | 0.0 | -0.5 | -0.5 | X |
| Total Protein | +3 g/dL | -0.1 | -0.1 | +0.1 | -0.1 | -0.5 | -0.5 | +0.8 |
| Lipids | 0.8% | +0.0 | +0.2 | +0.1 | +0.1 | +0.0 | +0.2 | +0.1 |
| Cholesterol | 9.1 mmol/L | 0.0 | +0.1 | 0.0 | 0.0 | 0.0 | 0.0 | +0.3 |
| Hydroxy butyrate | 20 mmol/L | +0.4 | -0.2 | +0.1 | -0.1 | -0.7 | -0.6 | -0.7 |
| Cysteine | 1 mmol/L | -0.2 | +0.2 | 0.0 | 0.0 | 0.0 | 0.0 | -0.1 |
| Bilirubin | 0.26 mmol/L | +0.1 | +0.2 | -0.1 | 0.0 | +0.1 | -0.2 | +0.1 |
| NH4 | 2 mmol/L | -0.3 | -0.3 | +0.5 | -0.1 | 0.0 | -0.1 | -0.1 |
| Phosphate | 2 mmol/L | X | X | X | -0.1 | 0.0 | -0.1 | -0.3 |

Figure 5.6 – Table Of Interference Test Data Expressed As Fraction Of Total Allowable Error (TE); Endogenous Interferences

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## 5.7 Summary of Clinical Tests Submitted in Support of Substantial Equivalence

#### 5.7.1 Method comparison with predicate device

The method comparison studies were performed in a field trial at a hospital on patient sample of whole blood at the point of care in the intensive care unit, the cardiac intensive care unit, the hematology/oncology department and in the central lab. Patient specimens were arterial, venous and mixed venous/arterial. The method comparison was against the predicate device.

| | N | Slope | Intercept | Syx | R | X min | X max |
|------|-----|-------|-----------|-------|-------|-------|-------|
| pH | 149 | 0.966 | 0.251 | 0.02 | 0.991 | 6.770 | 7.982 |
| pCO2 | 143 | 1.041 | -0.9 | 2.4 | 0.990 | 19.7 | 112.2 |
| pO2 | 142 | 1.053 | -1.7 | 6.6 | 0.978 | 26.0 | 226.5 |
| K | 146 | 1.013 | -0.02 | 0.09 | 0.993 | 2.5 | 7.8 |
| Na | 156 | 1.077 | -9.6 | 2.2 | 0.953 | 123 | 179 |
| iCa | 156 | 1.021 | -0.03 | 0.031 | 0.985 | 0.8 | 2.2 |
| Hct | 142 | 1.066 | -1.1 | 1.36 | 0.987 | 19 | 73 |

Figure 5.7 - Table - Method Comparison Summary

### Summary of Conclusions Drawn from Non Clinical and 5.8 Clinical Tests

We conclude from the data presented in section 5.6 that the device performs effectively. We conclude from the data section 5.7 that the clinical performance of the device is equivalent to the predicate device: i-Stat Model 300 Portable Clinical Analyzer.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# SEP 2 7 2006

Mr. Roy Layer Director of Quality Assurance and Regulatory Affairs Epocal, Inc. 2935 Conroy Road Ottawa, Canada K1G 6C6

Re: k061597

> Frade Device Name: EPOCTM Blood Analysis System Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (pCO2, pO2) and blood pH test system Regulatory Class: Class II Product Code: CHL, CEM, JFP, JPI, JGS Dated: August 19, 2006 Received: August 22 , 2006

Dear Mr. Layer:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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## Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Gutz

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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APPENDIX 10

## Indications for Use

510(k) Number (if known): K061597

Device Name: EPOC™ Blood Analysis System

Indications For Use:

The EPOC Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of whole blood in the laboratory or at the point of care in hospitals, nursing homes or other clinical care institutions.

The Blood Gas Electrolyte (BGE) test card panel configuration includes sensors for Sodium - Na, Potassium - K. ionized Calcium - iCa, pH, pCO2, pO2 and Hematocrit -Hct.

Measurement of Sodium and Potassium are used in diagnosis and treatment diseases involving electrolyte imbalance. Measurement of lonized Calcium is used in diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. Measurement of ph pCO2, p02 (blood gases) is used in the diagnosis and treatment of life-threatening acid-base disturbances. Measurement Hct distinguish normal from abnormal states of blood volume, such as anemia and erythrocvtosis.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C. Bauer
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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