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.

Device Description

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.

AI/ML Overview

Here's a detailed breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: EPOC Glucose Test (part of the EPOC Blood Analysis System)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the EPOC Glucose Test are not explicitly stated as quantitative targets in the document. Instead, the studies demonstrate the device's performance characteristics (precision, linearity, hematocrit effect, and analytical specificity) and then conclude equivalence to the predicate device. The performance data itself acts as the evidence to satisfy implicit acceptance criteria generally expected for such a device (i.e., that it performs reliably and comparably to a legally marketed device).

Therefore, the table below summarizes the reported performance characteristics from the provided studies. The acceptance criteria are inferred as demonstrating comparable or acceptable performance for each metric.

Performance Metric	Acceptance Criteria (Inferred)	Reported Device Performance
Aqueous Precision (CV%)	Low variability (e.g., comparable to industry standards)	L1: 2.30% CVL3: 2.30% CV
Blood Precision (CV%) - Glucose 20	≤ 4.8% CV (based on predicate/industry standards)	5.4% CV (Total) at 20 mg/dL (Note: One lot met 4.8% CV)
Blood Precision (CV%) - Glucose 120	≤ 4% CV (based on predicate/industry standards)	2.4% CV (Total) at 120 mg/dL
Blood Precision (CV%) - Glucose 200	≤ 4% CV (based on predicate/industry standards)	3.9% CV (Total) at 200 mg/dL
Blood Precision (CV%) - Glucose 300	≤ 6% CV (based on predicate/industry standards)	4.2% CV (Total) at 300 mg/dL
Blood Precision (CV%) - Glucose 500	≤ 6% CV (based on predicate/industry standards)	3.2% CV (Total) at 500 mg/dL
Linearity (Slope)	Close to 1.0	0.9996
Linearity (Intercept)	Close to 0.0	0.64
R-squared (Method Comparison)	High correlation (e.g., > 0.95 or 0.98)	R2: 0.999 (overall vs. predicate)
Hematocrit Effect (Bias)	Minimal bias across different Hct levels	Varied from -18.9 mg/dL to +20.0 mg/dL, with most biases being smaller than these extremes across different glucose and Hct levels. (Specific criteria for acceptable bias are not explicitly stated, but the values are presented as acceptable by the manufacturer.)
Analytical Specificity (Interference Bias)	Interferent bias < Total Allowable Error (TE)	Most interferents showed a bias as a fraction of TE to be < 1.0, with a few exceptions (e.g., L-Cysteine at 1.5 mM, NaFluoride at 100 mM, Mannose at 5 mM, CaOxalate at 78 mM, Thiocyanate at 6.9 mM, Uric Acid at 1.5 mM) exceeding this threshold. The document presents these results as acceptable.
Method Comparison (vs. Predicate)	Equivalent performance to the i-STAT Model 300	Slope ≈ 1.022, Intercept ≈ 2.338, R² ≈ 0.999 (overall)
Anticoagulant Effect	Similar performance for heparinized vs. unheparinized blood	Slope: 0.994 (heparinized), 1.019 (unheparinized)
Venous vs. Arterial Blood	Similar performance for arterial vs. venous blood	Slope: 0.991 (arterial), 1.028 (venous)
Altitude Effect	Equivalent performance at high altitude	Slope: 1.031, R²: 0.9976 (overall vs. ABL800Flex)

2. Sample Sizes Used for the Test Set and Data Provenance

Aqueous Precision: Not specified for each level, but "a twenty day precision study performed on 4 lots using aqueous controls at two levels L1 and L3."
Blood Precision:
- For each of five glucose concentrations (20, 120, 200, 300, 500 mg/dL): "over 100 cards/blood sample on 50 different readers." (e.g., 102 for 20 mg/dL, 98 for 120 mg/dL, 101 for 200 mg/dL, 105 for 300 mg/dL, 103 for 500 mg/dL).
Linearity/Reportable Range: "A total of nine blood samples were prepared."
Hematocrit Effect: Not explicitly stated for each measurement, but "six glucose level blood linearity studies performed at four different hematocrit levels." These are detailed in a large table.
Analytical Specificity: Not explicitly stated (number of replicates for each interferent tested).
Method Comparison with Predicate Device:
- Overall: N = 160 patient samples.
- Anticoagulant Effect: N = 58 patient samples (29 heparinized, 29 unheparinized).
- Venous versus Arterial Blood: N = 214 patient samples (100 arterial, 114 venous).
- Altitude Effect: N = 81 patient samples.
Data Provenance:
- In-house: Aqueous precision, blood precision, linearity/reportable range, hematocrit effect, analytical specificity.
- Field trials: Method comparison with predicate device, anticoagulant effect, venous versus arterial blood (at several hospitals/POC locations).
- Altitude Effect: Performed at an altitude of over 2000m (~6600 ft).
- Retrospective/Prospective: The text does not explicitly state "retrospective" or "prospective" for the clinical/field trials, but "patient samples" in method comparison studies typically implies prospective collection for the study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of "experts" to establish ground truth in the context of diagnostic interpretation. Instead, for quantitative analytical devices like this, ground truth is established using:

Reference instruments: For precision, linearity, and hematocrit studies, internal reference instruments (e.g., YSI, ISTAT, ABL) with traceability to NIST standards were used.
Predicate device: For method comparison, the i-Stat™ Model 300 Portable Clinical Analyzer served as the reference.
Other reference instrument: For the altitude study, the ABL800 Flex Radiometer whole blood instrument was used as the reference.

Therefore, the "ground truth" is established by these reference methods, not by human experts interpreting results.

4. Adjudication Method for the Test Set

Not applicable. This device is a quantitative diagnostic test for glucose. Ground truth is established by chemical reference methods and comparison to predicate devices, not by interpretation that requires adjudication (e.g., 2+1, 3+1).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a standalone quantitative glucose measurement device, not an AI-assisted diagnostic imaging or interpretation tool. There are no "human readers" in the context of MRMC studies for this type of device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the entire evaluation is for the standalone performance of the EPOC Glucose Test. The studies described (precision, linearity, method comparison, etc.) assess the accuracy and reliability of the device's glucose measurements directly, without involving human interpretation or integration into a diagnostic workflow for performance assessment. The device provides a quantitative numerical result.

7. The Type of Ground Truth Used

The ground truth for the device's performance evaluation was established using:

Reference instruments/systems:
- For in-house studies (precision, linearity, hematocrit), the device measurements were compared against "in-house reference instruments with traceability to NIST standards" (e.g., YSI, ISTAT, ABL).
- For calibration and quality control, the system uses materials with traceability to NIST standards (National Institute of Standards and Technology).
Predicate device: For the primary method comparison studies, the i-Stat™ Model 300 Portable Clinical Analyzer was used as the comparative "ground truth."
Other legally marketed device: For the altitude study, the ABL800 Flex Radiometer was used as the comparison "ground truth."

8. The Sample Size for the Training Set

The document does not explicitly mention a distinct "training set" in the context of an algorithm's development. This device likely relies on established electrochemical principles, sensor design, and calibration algorithms rather than a machine learning model that requires a separate training data set of patient samples. The "training" in this context would refer to the development and refinement of the sensor and software using internal laboratory samples and calibrators, leading to the final product validated in the studies mentioned.

9. How the Ground Truth for the Training Set Was Established

As noted above, a distinct "training set" for an algorithm in the machine learning sense is not mentioned. However, the development and calibration of the EPOC Glucose Test, which could be considered akin to "training" for a traditional analytical device, involved:

On-board calibration material: Prepared gravimetrically and assayed on reference systems calibrated with traceability to NIST standards.
Calibration verification fluids: Commercially available with concentration values traceable to NIST standards.
Quality control materials: Commercially available fluids with concentrations traceable to NIST standards.

These NIST-traceable reference materials and systems would have been crucial for establishing the accuracy and performance characteristics of the glucose sensor and measurement system during its development and manufacturing.

Summary

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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.2060 Walkley Road, Ottawa, Ontario, Canada K1G 3P5Telephone: (613) 738-6192Fax: (613) 738-6195
Contact:	Roy LayerDirector 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

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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 /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- on-board calibrator in sealed reservoir- an electrochemical multi-sensor array- port for sample introduction- fluid waste chamber	Unit-use cartridge with- on-board calibrator in sealed reservoir- an electrochemical multi-sensor array- port for sample introduction- 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 basedamperometric peroxide detection	Glu - glucose oxidase basedamperometric peroxide detection	same
Analyzer components	Two housings;1 - The reader comprising- Orifice for test card introduction- electrical connector to card- heater for 37°C operation- mechanical card engagement device foro making electrical contact to card's sensorso for rupture of calibrator reservoiro moving calibrator to sensorso engaging heaters with card- op-amp sensor signal detectors- iQC monitoring devices- Thermal controllers- MUX- A/D- Bluetooth stack for wireless transmission of digitized raw sensor signals to computing device- bar code scanner for acquiring card info- internal electronic reader self-test circuit2 - The computing device comprising a PDA- microprocessor- memory- color LCD display- keyboard- i/o for communicating test results to other devices- software to control the test and calculate analytical values from raw sensor signals- battery operated with rechargeable batteries via plug in plug-in power supply	A single housing comprising- Orifice for test card introduction- electrical connector to card- heater for 37°C operation- mechanical card engagement device foro making electrical contact to card's sensorso for rupture of calibrator reservoiro moving calibrator to sensorso engaging heaters with card- op-amp sensor signal detectors- iQC monitoring devices- Thermal controllers- MUX- A/D- wire transmission of digitized raw sensor signals to computing subsystem in same housing- n/a- internal and external electronic reader self-test circuit- microprocessor- memory- monochrome LCD display- keyboard- i/o for communicating test results to other devices- software to control the test and calculate analytical values from raw sensor signals- battery operated with rechargeable batteries via external power supply in downloader cradle	different
Measurement	37°C	37°C	same
temperature
Measurementsequence	Calibrate test card-introduce sample-measure	Introduce sample-calibrate testcartridge-measure	different
Measurementtime	30sec from sample introduction	200 sec from sample introduction	different
Errordetection	iQC system to detect user errorsiQC system for reader self-checkiQC system to detect card non-conformance	iQC system to detect user errorsiQC system for reader self-checkiQC system to detect card non-conformance	samesamesame

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EPOC Glucose Test - 510(k) Submission

Section 05 (REVISED) - Page 3 of 10

ﮯ

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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	0.9989Submission 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[PCV]	Glulevel	Ref. mean[mg/dL]	EPOC mean[mg/dL]	Mean 95%conf[mg/dL]	EPOC%CV	EPOC bias[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).

ExogenousInterference	Interferencelevel	CLSI	Mean (Test result -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

EndogenousInterference	Interferencelevel	CLSI	Mean (Test result –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[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[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	26-100mg/dL	100-300mg/dL	300-631mg/dL	26-631mg/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.

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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).

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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 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 (240) 276-0450. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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

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Indications for Use

510(k) Number: K090109

Device Name: epoc Glucose test

Indication For Use:

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

Page 1 of 1

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
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.(b)
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.