BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD

K090109 · Epocal, Inc. · CGA · Jun 24, 2009 · Clinical Chemistry

Device Facts

• Record ID: K090109
• Device Name: BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD
• Applicant: Epocal, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Jun 24, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The Glucose test, as part of 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 heparinized or un-anticoagulated arterial or venous whole blood in the laboratory or at the point of care in hospitals, nursing homes or other clinical care institutions. Glucose measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia, and pancreatic islet cell tumors.

Device Story

The epoc Blood Analysis System is a point-of-care diagnostic platform consisting of a handheld reader and a mobile computing device (epoc Host). It uses single-use test cards containing electrochemical sensor arrays. The glucose test adds a glucose oxidase-based amperometric sensor to the existing card panel. The user inserts a blood-filled card into the reader; the system automatically performs calibration, sample analysis, and data transmission to the Host. The Host displays and stores results. The device provides rapid quantitative glucose measurements to assist clinicians in diagnosing and managing metabolic disorders. It is designed for use by trained medical professionals in clinical environments.

Clinical Evidence

Bench testing only. Performance validated through precision studies (total CV 2.3% at 241.9 mg/dL), linearity (R²=0.9989, range 20-700 mg/dL), and method comparison against predicate devices (i-STAT, Hitachi) and reference methods. Comparison studies across 214 patient samples (arterial/venous) showed high correlation (slope 1.02, intercept -1.874, R²=0.997). Interference testing evaluated common anticoagulants and metabolites. Hematocrit effect was assessed across 30-62% range with no significant bias observed.

Technological Characteristics

The device uses an electrochemical glucose oxidase-based amperometric sensor. The test card is a unit-use, laminated foil sensor module with an on-board calibrator reservoir. The system operates at 37°C via a heater assembly. Connectivity is wireless (Bluetooth) between the Reader and the EPOC Host. The system is designed for point-of-care use. Software controls the automated test cycle, signal processing, and result calculation.

Indications for Use

Indicated for trained medical professionals to perform quantitative glucose testing on heparinized or un-anticoagulated arterial or venous whole blood. Used for diagnosis and treatment of carbohydrate metabolism disorders (diabetes mellitus, idiopathic hypoglycemia) and pancreatic islet cell tumors in clinical settings.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• i-Stat Glucose Test using i-Stat Model 300 Portable Clinical Analyzer (K001387)

Reference Devices

• ABL800 Flex Radiometer

Submission Summary (Full Text)

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# ероса

2060 Walkley Road Ottawa Ontario, Canada K1G 3P5

## JUN 2 4 2009

## 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: K090109.

| Summary Prepared: | May 21, 2009 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------|
| Submitted by: | Epocal Inc.<br>2060 Walkley Road, Ottawa, Ontario, Canada K1G 3P5<br>Telephone: [phone]<br>Fax: [phone] |
| Contact: | Roy Layer<br>Director of Quality Assurance and Regulatory Affairs. |

#### 5.1 Identification of the Device

| Device Name: | Glucose Oxidase, Glucose |
|---------------------------|--------------------------|
| Proprietary / Trade Name: | EPOC Glucose Test |
| Common Name: | Glucose Oxidase, Glucose |
| Classification Name: | Glucose Test System |
| Device Classification: | II |
| Regulation Number: | 862.1345 |
| Panel: | Clinical Chemistry |
| Product Code: | CGA |

#### 5.2 Identification of the Predicate Device

i-Stat™ Glucose Test using i-Stat™ Model 300 Portable Clinical Analyzer

#### Description of the New Device 5.3

The EPOC glucose test is being added as an additional sensor to the existing single use test card that is used with the EPOC Blood Analysis System. This test card is inserted into the EPOC Reader and all analytical steps are performed automatically. Patient and user information may be entered into the mobile computing device (EPOC Host) during the automated analysis cycle.

The EPOC Blood Analysis System is an in vitro analytical system comprising a network of one or more EPOC Readers designed to be used at the point of care (POC). The readers accept an EPOC single use test card containing a group of sensors that perform diagnostic testing on whole blood. The blood test results are transmitted wirelessly to an EPOC Host, which displays and stores the test results.

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The EPOC System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of whole blood.

The test card panel configuration currently includes sensors for Sodium Na, Potassium K, Ionized Calcium iCa, pH, pCO3, pO2 and Hematocrit Hct. This submission adds Glucose (Glu) to this list of approved tests.

To perform a blood test, a new test card is inserted into a card reader's card slot with white label face down. When fully inserted, the test card is automatically engaged in the reader.

The card insertion process:

- Brings the cards sensor module into contact with the reader's electrical contact . array;
- Brings the card's measurement region, which is the fluidic channel above the . sensor array, into thermal contact with the reader's heater assembly for heating the measurement region to 37°C;
- Actuates the opening of the fluidic valve in the card and causes delivery of . calibrator fluid from the reservoir to the measurement region.

After calibration, and upon a prompt by the reader (LED visual and audio beep), the user introduces a blood sample for measurement through the blood sample port to the card's measurement region. When sensors are contacted by the blood sample they generate electrical signals proportional to analyte concentrations in the blood sample, which are transmitted wirelessly by the Reader to the EPOC Host. The EPOC Host displays and stores the blood test results.

Changes to the EPOC Blood Analysis System required to introduce the Glucose test include:

- Developing a new Glucose sensor and adding it to the existing EPOC test card, . which was already designed to accommodate additional sensors;
- Modifications to the existing EpocHost software application to accommodate the . new test;
- . Labeling changes including indications for the Glucose test.

### 5.4 Comparison of Technological Characteristics To Predicate Device

| | EPOC Blood Analysis System | i-STAT Model 300 | Same /<br>Different |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| 510(k) # | To be determined | K001387 | |
| Item | Device | Predicate | |
| 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 using the BGEM (Blood Gas Electrolyte Metabolite) test card panels. | The i-STAT Model 300 Portable Clinical Analyzer is intended to be used by trained medical professionals for use with i-STAT test cartridges and MediSense blood glucose test strips. i-STAT cartridges comprise a variety of clinical chemistry tests and test panels. | same |
| Where used | hospital | hospital | same |
| Measured parameters | Gluc | Gluc | same |
| Sample type | Venous, arterial whole blood | Venous, arterial and capillary whole blood | same |
| Reportable range | Gluc 20 - 700 mg/dL | Gluc 20 - 700 mg/dL | same |
| Sample volume | 95-125 µL | 100µL | same |
| Test card | Unit-use card with<br>- on-board calibrator in sealed reservoir<br>- an electrochemical multi-sensor array<br>- port for sample introduction<br>- fluid waste chamber | Unit-use cartridge with<br>- on-board calibrator in sealed reservoir<br>- an electrochemical multi-sensor array<br>- port for sample introduction<br>- fluid waste chamber | same |
| Test card storage | Room temperature until expiry date | Fridge storage until expiry date including max 2 weeks at room temperature | different |
| Sensor array | A laminated foil sensor module | A micro-fabricated chip-set | different |
| Tests/sensor components | Glu - glucose oxidase based<br>amperometric peroxide detection | Glu - glucose oxidase based<br>amperometric peroxide detection | same |
| Analyzer 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 device for<br>o making electrical contact to card's sensors<br>o for rupture of calibrator reservoir<br>o moving calibrator to sensors<br>o 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 | 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 device for<br>o making electrical contact to card's sensors<br>o for rupture of calibrator reservoir<br>o moving calibrator to sensors<br>o 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 | different |
| Measurement | 37°C | 37°C | same |
| temperature | | | |
| Measurement<br>sequence | Calibrate test card-introduce sample-<br>measure | Introduce sample-calibrate test<br>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-<br>conformance | iQC system to detect user errors<br>iQC system for reader self-check<br>iQC system to detect card non-<br>conformance | same<br>same<br>same |

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EPOC Glucose Test - 510(k) Submission

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Section 05 (REVISED) - Page 3 of 10

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## 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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#### 5.5.1 Aqueous precision

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 performed on 4 lots using aqueous controls at two levels L1 and L3 for the blood gases, electrolytes and metabolytes.

| Glucose [mg/dL] | L1 | L3 |
|-----------------|-------|-------|
| Mean | 241.9 | 50.2 |
| SWR | 4.72 | 1.1 |
| SDD | 2.86 | 0.43 |
| ST | 5.52 | 1.18 |
| CV% | 2.30% | 2.30% |

Figure 5.3 – Table – 20 Day Precision Study Data

#### , 5.5.2 Blood precision

Experiments were performed in-house to demonstrate the precision of the EPOC glucose sensor. The table below shows the results of a study performed in house on whole blood samples prepared to five concentrations of glucose, using cards from four different lots and testing over 100 cards/blood sample on 50 different readers.

| Fluid | Lot | n | avg | SD | YSI | ISTAT | ABL | %CV | SWR | |
|-----------|---------|-----|-------|------|-------|-------|-------|------|-----------|------|
| 20 | 09072-8 | 4 | 25.4 | 1.2 | 25.4 | 24.0 | 26.0 | 4.8% | 2.4 mg/dL | pass |
| | 09096-7 | 24 | 22.1 | 1.2 | 25.4 | 24.0 | 26.0 | 5.2% | 2.4 mg/dL | pass |
| | 09097-7 | 29 | 22.7 | 1.0 | 25.4 | 24.0 | 26.0 | 4.6% | 2.4 mg/dL | pass |
| | 09098-7 | 45 | 22.4 | 1.0 | 25.4 | 24.0 | 26.0 | 4.4% | 2.4 mg/dL | pass |
| 20 Total | | 102 | 22.5 | 1.2 | 25.4 | 24.0 | 26.0 | 5.4% | 2.4 mg/dL | pass |
| 120 | 09072-8 | 10 | 121.5 | 2.6 | 124.0 | 120.0 | 125.0 | 2.1% | 4% | pass |
| | 09096-7 | 15 | 124.0 | 1.5 | 124.0 | 120.0 | 125.0 | 1.2% | 4% | pass |
| | 09097-7 | 28 | 123.6 | 2.9 | 124.0 | 120.0 | 125.0 | 2.3% | 4% | pass |
| | 09098-7 | 45 | 124.1 | 3.4 | 124.0 | 120.0 | 125.0 | 2.8% | 4% | pass |
| 120 Total | | 98 | 123.7 | 3.0 | 124.0 | 120.0 | 125.0 | 2.4% | 4% | pass |
| 200 | 09072-8 | 8 | 210.0 | 2.6 | 217.0 | 209.0 | 207.0 | 1.2% | 4% | pass |
| | 09096-7 | 19 | 216.5 | 7.0 | 217.0 | 209.0 | 207.0 | 3.2% | 4% | pass |
| | 09097-7 | 31 | 214.3 | 6.9 | 217.0 | 209.0 | 207.0 | 3.2% | 4% | pass |
| | 09098-7 | 43 | 217.9 | 10.2 | 217.0 | 209.0 | 207.0 | 4.7% | 4% | pass |
| 200 Total | | 101 | 215.9 | 8.5 | 217.0 | 209.0 | 207.0 | 3.9% | 4% | pass |
| 300 | 09072-8 | 2 | 302.1 | 2.1 | 305.0 | 305.0 | 291.0 | 0.7% | 6% | pass |
| | 09096-7 | 26 | 314.4 | 8.5 | 305.0 | 305.0 | 291.0 | 2.7% | 6% | pass |
| | 09097-7 | 32 | 309.2 | 17.9 | 305.0 | 305.0 | 291.0 | 5.8% | 6% | pass |
| | 09098-7 | 45 | 312.5 | 11.3 | 305.0 | 305.0 | 291.0 | 3.6% | 6% | pass |
| 300 Total | | 105 | 311.8 | 13.1 | 305.0 | 305.0 | 291.0 | 4.2% | 6% | pass |
| 500 | 09072-8 | 4 | 529.7 | 23.8 | 559.0 | 526.0 | 508.0 | 4.5% | 6% | pass |
| | 09096-7 | 25 | 554.2 | 14.6 | 559.0 | 526.0 | 508.0 | 2.6% | 6% | pass |
| | 09097-7 | 30 | 544.8 | 17.1 | 559.0 | 526.0 | 508.0 | 3.1% | 6% | pass |
| | 09098-7 | 44 | 548.9 | 17.8 | 559.0 | 526.0 | 508.0 | 3.2% | 6% | pass |
| 500 Total | | 103 | 548.3 | 17.6 | 559.0 | 526.0 | 508.0 | 3.2% | 6% | pass |

Figure 5.4 - Table - Blood Precision Study Data

EPOC Glucose Test - 510(k) Submission

Section 05 (REVISED) - Page 5 of 10

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#### 5.5.3 Linearity/Reportable Range

This study was performed in-house using blood samples as per CLSI EP6-A recommendations for evaluation of linearity. A total of nine blood samples were prepared starting with two pools of blood, which were evaluated versus in-house reference instruments with traceability to NIST standards. Regression analysis was performed as per CLSI EP6-A. The summary is given in the table in fiqure 5.5.

| | Slope | Intercept | 106 |
|-----|--------|-----------|------------------------------------------------------------------------------------------------------------|
| Glu | 0.9996 | 0.64 | 0.9989<br>Submission in the cases of the "can of the "can't of the "control of the count" of the county of |

| Figure | | | | | |
|--------|--|--|--|--|--|
|--------|--|--|--|--|--|

#### 5.5.4 Traceability

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

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

#### 5.5.5 Detection Limit

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

#### 5.5.6 Effect of Hematocrit

Hematocrit effect was evaluated in six glucose level blood linearity studies performed at four different hematocrit levels.

The hematocrit was evaluated as per CLSI H07-A2 recommendations. The reference mean glucose concentration was computed from the average of at least two in house reference instruments with traceability to NIST standards.

| Hct<br>[PCV] | Glu<br>level | Ref. mean<br>[mg/dL] | EPOC mean<br>[mg/dL] | Mean 95%conf<br>[mg/dL] | EPOC<br>%CV | EPOC bias<br>[mg/dL] |
|--------------|--------------|----------------------|----------------------|-------------------------|-------------|----------------------|
| 30 | 35 | 33.7 | 34.9 | 2.1 | 8.4% | 1.2 |
| 30 | 60 | 54.5 | 55.6 | 1.0 | 2.5% | 1.1 |
| 30 | 130 | 128.7 | 127.9 | 1.2 | 1.3% | -0.7 |
| 30 | 200 | 209.3 | 212.6 | 3.2 | 2.1% | 3.2 |
| 30 | 400 | 407.2 | 425.4 | 7.9 | 2.6% | 18.2 |
| 30 | 600 | 608.3 | 601.4 | 14.8 | 3.3% | -7.0 |
| 43 | 35 | 36.6 | 36.0 | 1.1 | 1.2% | -0.6 |
| 43 | 50 | 49.2 | 46.4 | 0.8 | 3.8% | -2.7 |
| 43 | 100 | 96.8 | 95.4 | 1.8 | 5.7% | -1.4 |
| 43 | 130 | 129.9 | 128.4 | 2.7 | 2.2% | -1.5 |

The summary is presented in the Table below:

EPOC Glucose Test - 510(k) Submission

Section 05 (REVISED) - Page 6 of 10

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| 43 | 200 | 204.7 | 205.3 | 2.0 | 2.6% | 0.6 |
|----|-----|-------|-------|------|------|-------|
| 43 | 350 | 330.7 | 346.4 | 10.8 | 2.4% | 15.7 |
| 43 | 650 | 670.5 | 690.5 | 32.4 | 4.0% | 20.0 |
| 52 | 35 | 34.0 | 35.9 | 2.1 | 5.8% | 1.9 |
| 52 | 60 | 55.7 | 55.8 | 1.0 | 2.7% | 0.1 |
| 52 | 130 | 130.7 | 129.7 | 1.2 | 1.5% | -0.9 |
| 52 | 200 | 216.0 | 210.2 | 3.2 | 1.3% | -5.8 |
| 52 | 400 | 416.7 | 417.3 | 7.9 | 2.0% | 0.7 |
| 52 | 600 | 615.2 | 596.2 | 14.8 | 5.1% | -18.9 |
| 62 | 35 | 29.7 | 31.6 | 0.6 | 2.1% | 1.9 |
| 62 | 50 | 46.8 | 45.9 | 0.4 | 1.2% | -1.0 |
| 62 | 100 | 95.4 | 93.9 | 1.9 | 1.8% | -1.5 |
| 62 | 130 | 127.5 | 121.7 | 1.3 | 1.0% | -5.8 |
| 62 | 200 | 205.1 | 201.6 | 3.5 | 1.3% | -3.4 |
| 62 | 350 | 326.0 | 336.0 | 3.2 | 2.5% | 10.0 |
| 62 | 650 | 666.0 | 685.3 | 9.8 | 2.2% | 19.2 |

Figure 5.6 - Table - Summary of glucose blood linearity results at various Hct levels

#### Analytical Specificity 5.5.7

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 '%' is indicated).

| Exogenous<br>Interference | Interference<br>level | CLSI | Mean (Test result -<br>blank control)/TE |
|---------------------------|-----------------------|--------|------------------------------------------|
| Acetaminophen | 1.66 mM | 1.6mM | -0.4 |
| N-Acetyl Cysteine | 0.5 mM | 16.6mM | -0.7 |
| N-Acetyl Cysteine | 1 mM | 16.6mM | -12% |
| Acetyl Salicylic Acid | 3.33 mM | 3.33mM | +0.3 |
| Na Ascorbate | 630 μΜ | 227μΜ | +0.2 |
| Bromide | 15 mM | 37.5mM | -0.6 |
| Bromide | 25 mM | 37.5mM | -10% |
| CaOxalate | 78 mM | - | -23% |
| Citrate | 15 mM | - | -0.4 |
| Citrate | 20 mM | - | -8% |
| Cyanide | 0.1 mM | - | -0.1 |
| Digoxin | 6.15 nM | 6.15nM | -0.1 |
| Dobutamine | 66 μΜ | - | +0.2 |
| Dopamine HCl | 100 μΜ | 5.87μΜ | -0.4 |
| L-dopa | 1 mg/dL | - | -0.4 |
| L-dopa | 2 mg/dL | - | -11% |
| Methyldopa | 71 μΜ | 71μΜ | -0.7 |
| EDTA | 9 mM | - | -0.6 |
| Ephedrine | 12 μΜ | - | +0.1 |
| Ethanol | 87 mM | 86.8mM | +0.3 |
| Ethylene Glycol | 4.84 mM | 4.83mM | 0.0 |
| NaFluoride | 10 mM | 105μΜ | -0.6 |
| NaFluoride | 100 mM | 105μΜ | -16% |

EPOC Glucose Test - 510(k) Submission

Section 05 (REVISED) - Page 7 of 10

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| Fructose | 1 mM | | -0.2 |
|------------------------|--------------------------------------|--------------------------------------|------|
| Galactose | 3.3 mM | - | +0.4 |
| Gallamine Triethiodide | 0.5 mg/dL | - | -0.5 |
| Gallamine Triethiodide | 1 mg/dL | - | -10% |
| Gentamicin | 100 $ \mu $ g/mL | 100 $ \mu $ g/mL | +0.1 |
| Glipizide | 4.5 $ \mu $ M | 4.5 $ \mu $ M | +0.1 |
| Glucosamine | 1.1 mM | - | 0.0 |
| Glutathione oxidized | 2.55mmol/LRBC | - | -0.2 |
| Glutathione reduced | 2.55mmol/LRBC | - | -0.5 |
| Glycolic Acid | 1 mM | - | 0.0 |
| Guaiacol | 0.4 mM | - | 0.1 |
| Heparin | 80 U/mL | 3 U/mL | -0.3 |
| HydroxyUrea | 2.5 mM | | +0.5 |
| Isoniazide (Nydrazid) | 292 $ \mu $ M | 292 $ \mu $ M | -0.6 |
| Ibuprofen | 2.5 mM | 2.425 mM | 0.0 |
| Maltose | 13.3 mM | - | -0.1 |
| Mannose | 3.5 mM | - | +0.4 |
| Mannose | 5 mM | - | +15% |
| NaPenthotal | 413 $ \mu $ M | 248 $ \mu $ M | -0.1 |
| Procainamide | 102 $ \mu $ M | 102 $ \mu $ M | 0.0 |
| Quinidine | 37 $ \mu $ M | 37 $ \mu $ M | -0.7 |
| Salycilic Acid | 4.34 mM | 4.34 mM | -0.2 |
| Thiocyanate | 1 mM | 6.9 mM | -0.7 |
| Thiocyanate | 6.9 mM | 6.9 mM | -16% |
| Tolazamide (Tolinase) | 1 mM | | -0.3 |
| Tolbutamide | 2.37 mM | 2.37 mM | +0.1 |
| Xylose | 3 mM | | +0.1 |
| Xylose | 4 mM | | +8% |

Figure 5.7 – Table of Interference Test Data Expressed as Fraction of Total Allowable Error (TE); Exogenous Interferences for the Glucose Sensor

| Endogenous<br>Interference | Interference<br>level | CLSI | Mean (Test result –<br>blank control)/TE |
|----------------------------|-----------------------|-----------|------------------------------------------|
| Bilirubin Conj | 86 μΜ | 86 μΜ | 0.0 |
| Bilirubin Unconj | 513 μΜ | 257 μΜ | 0.0 |
| Cholesterol | 7.7 mM | 6.47 mM | +0.5 |
| L-Cysteine | 0.5 mM | - | -0.4 |
| L-Cysteine | 1.5 mM | - | -31% |
| Hydroxy Butyrate | 20 mM | - | -0.4 |
| Intralipid | 0.8% | - | 0.0 |
| Lactate | 20 mM | 2.6 mM | -0.5 |
| pH Acidic | 6.66 | - | -0.2 |
| pH Alkaline | 7.72 | - | -0.3 |
| Norepinephrine | 59.2 μΜ | 10.4 nM | 0.0 |
| Low Total protein | 3.4% | 6% | +0.1 |
| High Total Protein | 10.4% | 8% | -0.1 |
| Triglycerides | 500 mg/dL | 500 mg/dL | -0.2 |
| Uric Acid | 0.5 mM | 0.5 mM | -0.6 |
| Uric Acid | 1.5 mM | 0.5 mM | -15% |

Figure 5.8 – Table of Interference Test Data Expressed as Fraction of Total Allowable Error (TE); Endogenous Interferences for the Glucose Sensor

EPOC Glucose Test - 510(k) Submission

Section 05 (REVISED) - Page 8 of 10

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### Summary of Clinical Tests Submitted in Support of 5.6 Substantial Equivalence

#### Method comparison with predicate device 5.6.1

The method comparison studies were performed in field trials at several hospitals on patient samples of whole blood at various locations. Patient specimens were capillary, arterial and venous. The method comparison was against the predicate device.

| | | Slope | Intercept | SVX | | X mir | x max |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|-------|-----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|-------|-------|
| ﻟﻠﻘﺎﻧﻮﻥ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ | 160 | 1.022 | 2.338 | ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ | 0.999 | 20.0 | 605.5 |

Figure 5.9 - Table of Method Comparison Summary against Predicate Device

#### 5.6.2 Matrix effects

#### 5.6.2.1 Effect of anticoagulant

The effect of anticoaqulant was evaluated on patient samples that were collected using heparinized and non-heparinized collection devices. This study was performed at various POC sites of a hospital. The data was analyzed using EP9-2A methodology. The table in figure 5.10 shows the method comparison summary versus the predicate device.

| Glucose<br>[mg/dL] | Heparinized | Unheparinized | All |
|--------------------|-------------|---------------|--------|
| N | 29 | 29 | 58 |
| Sxx | 1.22 | 1.07 | 1.14 |
| Syy | 3.24 | 3.00 | 3.12 |
| intercept | 2.0 | -0.7 | 0.7 |
| slope | 0.994 | 1.019 | 1.006 |
| Syx | 4.94 | 4.21 | 4.57 |
| X min | 77.5 | 65 | 65 |
| X max | 266.5 | 268.5 | 268.5 |
| R2 | 0.9917 | 0.9939 | 0.9926 |

Figure 5.10 - Table of Method Comparison Summary against Predicate Device

#### 5.6.2.2 Venous versus Arterial Blood

Clinical data from method comparison studies performed in field trials at several hospitals and POC locations, on patient samples of whole blood, were analyzed separately as arterial and venous. The data was analyzed using EP9-2A methodology. The table in figure 5.11 shows the method comparison summary vs the predicate device.

| Glucose<br>[mg/dL] | Arterial | Venous | All |
|--------------------|----------|--------|-----|
| N | 100 | 114 | 214 |
| Sxx | 1.02 | 2.76 | 2.1 |
| Syy | 3.33 | 4.00 | 3.7 |

Section 05 (REVISED) - Page 9 of 10

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| intercept | 1.89 | -3.03 | -1.874 |
|-----------|--------|--------|--------|
| slope | 0.991 | 1.028 | 1.020 |
| Syx | 4.45 | 5.55 | 5.2 |
| X min | 26 | 20 | 20.0 |
| X max | 355.0 | 605.5 | 605.5 |
| R² | 0.9945 | 0.9977 | 0.9969 |

Figure 5.11 - Table of Method Comparison Summary against Predicate Device

#### 5.6.2.3 -Effect of Altitude

A method comparison study was performed at an altitude of over 2000m (~6600 ft) aqainst ABL800 Flex Radiometer whole blood instrument. The data was analyzed using EP9-2A methodology. The table in figure 5.12 shows the method comparison summary.

| Glucose | 26-100<br>mg/dL | 100-300<br>mg/dL | 300-631<br>mg/dL | 26-631<br>mg/dL |
|-----------|-----------------|------------------|------------------|-----------------|
| N | 39 | 26 | 16 | 81 |
| Sxx | 2.2 | 4.3 | 22.9 | 10.6 |
| Syy | 1.3 | 4.4 | 13.6 | 6.6 |
| intercept | -1.9 | -4.1 | -5.9 | -6.12 |
| slope | 0.986 | 1.009 | 1.032 | 1.031 |
| Syx | 2.8 | 8.0 | 17.1 | 8.8 |
| X min | 26.0 | 99.5 | 301.0 | 26 |
| X max | 97 | 290 | 631.5 | 631.5 |
| R2 | 0.975 | 0.985 | 0.978 | 0.9976 |

Figure 5.12 - Table - Method Comparison Summary vs ABL800Flex

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

We conclude from the data presented in section 5.5 that the device performs effectively. We conclude from the data section 5.6 that the clinical performance of the device is equivalent to the predicate device: i-Stat Model 300 Portable Clinical Analyzer.

{10}------------------------------------------------

Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with a caduceus symbol superimposed on its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 4 2009

Epocal, Inc. c/o Roy Layer Director Quality Assurance & Regulatory Affairs 2060 Walkley Rd. .. Ottawa, Ontario, CA K1G-3P5

Re: k090109

Trade/Device Name: Blood Gas, Electrolyte And Metabolite Test Card Regulation Number: 21 CFR 862.1345 Glucose test system. Regulation Name: Regulatory Class: II Product Code: CGA Dated: June, 16, 2009 Received: June 17, 2009

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice, requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

{11}------------------------------------------------

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 advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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.

G.C.H.

Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

### Enclosure

{12}------------------------------------------------

## Indications for Use

510(k) Number: k090109

Device Name: epoc Glucose test

Indication For Use:

The Glucose test, as part of 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 heparinized or un-anticoagulated arterial or venous whole blood in the laboratory or at the point of care in hospitals, nursing homes or other clinical care institutions.

Glucose measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, and idiopathic hypoglycemia, and of pancreatic islet cell tumors.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k090109

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