Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard in vitro diagnostic device for glucose measurement using electrochemical sensors and automated analysis. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies are standard analytical validation studies for IVD devices.

Therapeutic

No.
The device is an in vitro diagnostic device used to measure glucose levels for diagnosis and treatment, not a therapeutic device that directly treats a condition.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use by trained medical professionals as an in vitro diagnostic device" and that "Glucose measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of carbohydrate metabolism disorders".

SaMD (Software as a Medical Device)

No

The device description clearly states it is an in vitro diagnostic system comprising hardware components (EPOC Readers, single use test cards, EPOC Host) that perform analytical steps on whole blood samples. While software is involved in transmitting and displaying results, the core function relies on physical components and chemical reactions.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The document explicitly states the device 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". This directly aligns with the definition of an IVD, which is used to examine specimens taken from the human body to provide information for diagnosis, treatment, or prevention of disease.
Device Description: The description details a system that performs "diagnostic testing on whole blood", further supporting its IVD classification.
Performance Studies: The document includes detailed descriptions of performance studies, which are a requirement for demonstrating the safety and effectiveness of an IVD.
Predicate Device: The mention of a "Predicate Device(s)" with a K number (K001387) indicates that this device is being compared to a previously cleared IVD, a common practice in the regulatory pathway for IVDs.

The information provided clearly indicates that the epoc Blood Analysis System with the Glucose test is designed and intended for in vitro diagnostic use.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 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.

Product codes (comma separated list FDA assigned to the subject device)

CGA

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained medical professionals / laboratory, point of care in hospitals, nursing homes or other clinical care institutions

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Aqueous precision: Twenty day precision study performed on 4 lots using aqueous controls at two levels L1 and L3 for the blood gases, electrolytes and metabolytes.
Results for Glucose [mg/dL]:
L1: Mean 241.9, SWR 4.72, SDD 2.86, ST 5.52, CV% 2.30%
L3: Mean 50.2, SWR 1.1, SDD 0.43, ST 1.18, CV% 2.30%

Blood precision: 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.
Results for Glucose [mg/dL], sample size (n) for each lot and total:
Fluid 20: Total n=102, avg 22.5, SD 1.2, YSI 25.4, ISTAT 24.0, ABL 26.0, %CV 5.4%, SWR 2.4 mg/dL
Fluid 120: Total n=98, avg 123.7, SD 3.0, YSI 124.0, ISTAT 120.0, ABL 125.0, %CV 2.4%, SWR 4%
Fluid 200: Total n=101, avg 215.9, SD 8.5, YSI 217.0, ISTAT 209.0, ABL 207.0, %CV 3.9%, SWR 4%
Fluid 300: Total n=105, avg 311.8, SD 13.1, YSI 305.0, ISTAT 305.0, ABL 291.0, %CV 4.2%, SWR 6%
Fluid 500: Total n=103, avg 548.3, SD 17.6, YSI 559.0, ISTAT 526.0, ABL 508.0, %CV 3.2%, SWR 6%

Linearity/Reportable Range: Study performed in-house using nine blood samples as per CLSI EP6-A recommendations for evaluation of linearity. Regression analysis performed as per CLSI EP6-A.
Results for Glu: Slope 0.9996, Intercept 0.64, R2 0.9989.

Effect of Hematocrit: Evaluated in six glucose level blood linearity studies performed at four different hematocrit levels (30, 43, 52, 62). Hematocrit evaluated as per CLSI H07-A2 recommendations.
Results show varying bias across different Hct and glucose levels. For example, at Hct 30 and Glue level 400, bias is 18.2 mg/dL. At Hct 62 and Glucose level 650, bias is 19.2 mg/dL.

Analytical Specificity (Interference studies):
Exogenous Interferences (Example results): Acetaminophen (-0.4 TE), N-Acetyl Cysteine (-0.7 TE, -12%), Acetyl Salicylic Acid (+0.3 TE), Na Ascorbate (+0.2 TE), Bromide (-0.6 TE, -10%), CaOxalate (-23%).
Endogenous Interferences (Example results): Bilirubin Conj (0.0 TE), Bilirubin Unconj (0.0 TE), Cholesterol (+0.5 TE), L-Cysteine (-0.4 TE, -31%), Hydroxy Butyrate (-0.4 TE), Intralipid (0.0 TE).

Method comparison with predicate device: Performed in field trials at several hospitals on patient samples of whole blood (capillary, arterial, venous) against the predicate device.
Summary against Predicate Device (Glucose): n=160, Slope 1.022, Intercept 2.338, R2 0.999, X min 20.0, X max 605.5.

Matrix effects - Effect of anticoagulant: Patient samples collected using heparinized and non-heparinized devices at various POC sites of a hospital. Data analyzed using EP9-2A methodology.
Comparison summary versus predicate device:
Heparinized: N=29, intercept 2.0, slope 0.994, R2 0.9917.
Unheparinized: N=29, intercept -0.7, slope 1.019, R2 0.9939.
All: N=58, intercept 0.7, slope 1.006, R2 0.9926.

Matrix effects - Venous versus Arterial Blood: Clinical data from method comparison studies performed in field trials at several hospitals and POC locations. Data analyzed using EP9-2A methodology.
Comparison summary versus predicate device:
Arterial: N=100, intercept 1.89, slope 0.991, R2 0.9945.
Venous: N=114, intercept -3.03, slope 1.028, R2 0.9977.
All: N=214, intercept -1.874, slope 1.020, R2 0.9969.

Matrix effects - Effect of Altitude: Method comparison study performed at an altitude of over 2000m (~6600 ft) against ABL800 Flex Radiometer whole blood instrument. Data analyzed using EP9-2A methodology.
Comparison summary vs ABL800Flex (Glucose):
26-100 mg/dL: N=39, intercept -1.9, slope 0.986, R2 0.975.
100-300 mg/dL: N=26, intercept -4.1, slope 1.009, R2 0.985.
300-631 mg/dL: N=16, intercept -5.9, slope 1.032, R2 0.978.
26-631 mg/dL: N=81, intercept -6.12, slope 1.031, R2 0.9976.

Conclusion: Device performs effectively and clinical performance is equivalent to the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

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

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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 3P5
Telephone: (613) 738-6192
Fax: (613) 738-6195
Contact:	Roy Layer
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.

1

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 based
amperometric peroxide detection | Glu - glucose oxidase based
amperometric 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 for
o making electrical contact to card's sensors
o for rupture of calibrator reservoir
o moving calibrator to sensors
o 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 circuit
2 - 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 for
o making electrical contact to card's sensors
o for rupture of calibrator reservoir
o moving calibrator to sensors
o 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 | | | |
| Measurement
sequence | Calibrate test card-introduce sample-
measure | Introduce sample-calibrate test
cartridge-measure | different |
| Measurement
time | 30sec from sample introduction | 200 sec from sample introduction | different |
| Error
detection | iQC system to detect user errors
iQC system for reader self-check
iQC system to detect card non-
conformance | iQC system to detect user errors
iQC system for reader self-check
iQC system to detect card non-
conformance | same
same
same |

2

EPOC Glucose Test - 510(k) Submission

.

:

.

Section 05 (REVISED) - Page 3 of 10

:

ﮯ

3

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.

4

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

5

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
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
[PCV] | Glu
level | 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

6

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

EPOC Glucose Test - 510(k) Submission

Section 05 (REVISED) - Page 7 of 10

7

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
Interference | Interference
level | 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

8

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

9

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
mg/dL | 100-300
mg/dL | 300-631
mg/dL | 26-631
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 (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

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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