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

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

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

Device Description

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

EPOC Test Card: The single use blood test card comprises a port for introduction of a blood sample to an array of sensors on a sensor module. The sensor module is mounted proximal to a fluidic channel contained in a credit-card sized housing. The card has an on-board calibrator contained in a sealed reservoir fluidically connected to the senor array through a valve.
EPOC Card Reader: The reader is a minimally featured raw-signal acquisition peripheral. The reader comprises a card orifice for accepting a test card, and a mechanical actuation assembly for engaging the test card after it is inserted into the card orifice. Within the reader's card orifice there is a bar code scanner, an electrical contact array for contacting the card's sensor module, and a thermal subsystem for heating the card's measurement region to 37°C during the test. The reader also comprises circuits for amplifying, digitizing and converting the raw sensor signals to a wireless transmittable Bluetooth™ format.
EPOC Host: The host is a dedicated use Personal Digital Assistant (PDA) computing device with custom software that displays the test results. The reader and host computer together constitute all of the subsystems generally found in a traditional analyzer that operates on unit-use sensors and reagents.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the EPOC™ Blood Analysis System:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for each parameter in the same way a regulatory body might define them (e.g., "bias must be less than X," or "CV must be less than Y"). However, the non-clinical and clinical test results implicitly serve as the demonstrated "performance" against which substantial equivalence is claimed to a predicate device. For the purpose of this analysis, I will synthesize the linearity data as a primary indicator of performance across relevant ranges.

Parameter	Accepted Study Performance (Linearity Slope & R²)	Performance against Predicate (Slope & R)
pH	Slope: 1.021, R²: 0.998	Slope: 0.966, R: 0.991
pCO2	Slope: 1.058, R²: 0.998	Slope: 1.041, R: 0.990
pO2	Slope: 1.022, R²: 0.999	Slope: 1.053, R: 0.978
Na	Slope: 0.973, R²: 0.999	Slope: 1.077, R: 0.953
K	Slope: 1.006, R²: 0.999	Slope: 1.013, R: 0.993
iCa	Slope: 1.017, R²: 0.998	Slope: 1.021, R: 0.985
Hct	Slope: 1.005, R²: 0.999	Slope: 1.066, R: 0.987

Note on "Acceptance Criteria": The document claims the device performs effectively based on the non-clinical data and that its clinical performance is equivalent to the predicate device. The strong linearity and high R-squared values for the in-house linearity study (indicating a close fit to a linear model) and the clinical method comparison study (comparing the device to the predicate) would be the basis for these conclusions. Specific numerical acceptance cutoffs are not provided in this summary.

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

Non-Clinical (Precision Study - Aqueous Controls):
- Sample Size: Not explicitly stated as a number of unique samples, but refers to "n=20 replicates on each of 2 controls per day over 20 days" for the 20-day precision study with aqueous controls. This implies 800 measurements for blood gases and electrolytes (20 days * 2 controls * 20 replicates) and 400 measurements for hematocrit (20 days * 2 controls * 10 replicates for each level A and B, assuming 10 replicates per control per day).
- Data Provenance: In-house laboratory.
Non-Clinical (Precision Study - Whole Blood Field Trials):
- Sample Size: 10 replicates of different whole blood patient samples for each operator at each site. There were 7 operators across 3 sites.
- Data Provenance: Three point-of-care sites (hospitals, nursing homes, or other clinical care institutions), located in Canada (judging by the company address).
Non-Clinical (Linearity Study):
- Sample Size: Not explicitly stated, but performed "in-house." The results are presented for a "Test range" rather than a number of distinct samples.
- Data Provenance: In-house laboratory.
Non-Clinical (Interference Studies):
- Sample Size: Not explicitly stated.
- Data Provenance: Not explicitly stated, but implied to be in-house.
Clinical (Method Comparison Study):
- Sample Size:
  - pH: 149
  - pCO2: 143
  - pO2: 142
  - K: 146
  - Na: 156
  - iCa: 156
  - Hct: 142
- Data Provenance: Patient samples of whole blood from a hospital in a field trial. Locations included the intensive care unit, cardiac intensive care unit, hematology/oncology department, and the central lab. Sample types included arterial, venous, and mixed venous/arterial. The country of origin is not explicitly stated in this section, but the company is Canadian, suggesting Canadian sites.

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

This information is not provided in the document. For device performance studies like these, the "ground truth" is typically established by measurements from a reference method (often a central lab analyzer or a predicate device, as used here). The expertise would lie in the operation and validation of these reference methods, rather than clinical consensus.

4. Adjudication Method for the Test Set

This concept is not directly applicable to the type of device performance studies described (analytical accuracy and precision studies). Adjudication usually pertains to human expert review of clinical cases, particularly in imaging or diagnostic accuracy studies where there's subjectivity. In this case, results are quantitative measurements compared to a reference standard or predicate device.

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

No, an MRMC comparative effectiveness study was not done. This type of study applies to diagnostic devices where human interpretation is involved, often with AI assistance. The EPOC Blood Analysis System is an in vitro diagnostic device providing quantitative measurements, not an interpretive aid for human readers.

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

Yes, the performance studies presented (precision, linearity, interference, and method comparison) are essentially standalone performance studies of the device's ability to accurately measure the target analytes. The device generates quantitative results without requiring human interpretation of raw signals; human-in-the-loop performance is not a relevant concept for this type of automated analyzer. The "operators" in the field trial precision study are performing the sample introduction and use of the device, not interpreting results in a subjective manner.

7. The Type of Ground Truth Used

Non-Clinical (Precision, Linearity, Interference): The ground truth was established using in-house standard methods with traceability to NIST standards (for linearity) and aqueous controls or prepared samples with known concentrations.
Clinical (Method Comparison): The ground truth was established by comparing the EPOC system's measurements to those obtained from the predicate device, the i-Stat™ Model 300 Portable Clinical Analyzer. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices.

8. The Sample Size for the Training Set

Not explicitly stated. The document describes performance testing, but there is no explicit mention of a "training set" in the context of machine learning or AI models. This device is an automated sensor-based system, not a machine learning algorithm that requires a distinct training phase in the same way. The development and calibration would involve internal testing, but not a formally defined "training set" as understood in AI studies. The "calibration materials" and "quality control materials" mentioned contribute to the device's operational robustnes and accuracy.

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

As noted above, a "training set" as in machine learning is not applicable here. However, the reference materials used for calibration (which could be considered analogous in a broad sense to establishing a "truth" for the device's internal algorithms) are:
- On-board calibration material: Prepared gravimetrically and assayed on reference systems calibrated with traceability to NIST standards.
- Calibration verification fluids: Commercially available, traceable to NIST standards.
- Quality control materials: Commercially available, traceable to NIST standards.

Summary

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APPENDIX 9

K061597

e pocal

SEP 27 2006

2935 Conroy Road Ottawa Ontario, Canada K1G 6C6

510(k) SUMMARY

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

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

Summary Prepared: June 7, 2006

Submitted by:	Epocal Inc.
	2935 Conroy Road, Ottawa, Ontario, Canada K1G 6C6Telephone: (613) 738-6192Fax: (613) 738-6195

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

Identification of the Device 5.1

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

Name	Class	RegulationNumber	Panel	ProductCode
Electrode, Ion Specific, Sodium	II	862.1665	ClinicalChemistry	JGS
Electrode, Ion Specific, Potassium	II	862.1600	ClinicalChemistry	CEM
Hematocrit	II	864.6400	Hematology	JPI
Electrode, Ion Specific, Calcium	II	862.1145	ClinicalChemistry	JFP
Electrode Measurement, Blood-Gases (PCO2, PO2) and Blood pH	II	862.1120	ClinicalChemistry	CHL

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

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5.2 Identification of the Predicate Device

i-Stat™ Model 300 Portable Clinical Analyzer

5.3 Description of the New Device

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

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

1. EPOC Test Card
  The single use blood test card comprises a port for introduction of a blood sample to an array of sensors on a sensor module. The sensor module is mounted proximal to a fluidic channel contained in a credit-card sized housing. The card has an on-board calibrator contained in a sealed reservoir fluidically connected to the senor array through a valve.
1. EPOC Card Reader
  The reader is a minimally featured raw-signal acquisition peripheral. The reader comprises a card orifice for accepting a test card, and a mechanical actuation assembly for engaging the test card after it is inserted into the card orifice. Within the reader's card orifice there is a bar code scanner, an electrical contact array for contacting the card's sensor module, and a thermal subsystem for heating the card's measurement region to 37°C during the test. The reader also comprises circuits for amplifying, digitizing and converting the raw sensor signals to a wireless transmittable Bluetooth™ format,
1. EPOC Host
  The host is a dedicated use Personal Digital Assistant (PDA) computing device with custom software that displays the test results. The reader and host computer together constitute all of the subsystems generally found in a traditional analyzer that operates on unit-use sensors and reagents

5.4 Intended Use of the Device

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

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

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	EPOC Blood Analysis System				i-STAT Model 300K001387		Same /Different
510(k) #Item	Device			Predicate
Intendeduse	The EPOC Blood Analysis System isintended for use by trained medicalprofessionals as an in vitro diagnosticdevice for the quantitative testing ofsamples of whole blood using the BGE(Blood Gas Electrolyte) and ABG(Arterial Blood Gas) test card panels.			The i-STAT Model 300 Portable ClinicalAnalyzer is intended to be used bytrained medical professionals for usewith i-STAT test cartridges andMediSense blood glucose test strips.i-STAT cartridges comprise a varietyof clinical chemistry tests and testpanels.			same
Where used	hospital			hospital			same
Measuredparameters	pH, pCO2, pO2, Na, K, iCa, Hct			pH, pCO2, pO2, Na, K, iCa, Hct			same
Calculatedparameters	TCO2, HCO3, BE, SO2, Hgb			TCO2, HCO3, BE, SO2, Hgb			same
Sample type	Venous, arterial whole blood			Venous, arterial and skin puncturewhole blood			same
Reportableranges	pH	6.5 - 8.0	pH units	pH	6.5 - 8.2	pH units	different
	pCO2	5 - 250	mm Hg	pCO2	5 - 130	mm Hg	different
	pO2	5 - 750	mm Hg	pO2	5 - 800	mm Hg	same
	Na	85 - 180	mmol/L	Na	100 - 180	mmol/L	different
	K	1.5 - 12	mmol/L	K	2.0 - 9.0	mmol/L	different
	iCa	0.25 - 4	mmol/L	iCa	0.25 - 2.5	mmol/L	different
	Hct	10 - 75	%PCV	Hct	10 - 75	%PCV	same
	TCO2	1 - 85	mmol/L	TCO2	5 - 50	mmol/L	different
	HCO3	1 - 85	mmol/L	HCO3	1 - 85	mmol/L	same
	BEecf	-30 - +30	mmol/L	BEecf	-30 - +30	mmol/L	same
	BEb	-30 - +30	mmol/L	BEb	-30 - +30	mmol/L	same
	SO2	0 - 100	%	SO2	0 - 100	%	same
	Hb	3.3 - 25	g/dL	Hb	3 - 26	g/dL	same
Samplevolume	95-125 μL			100μL			same
Test card	Unit-use card with- on-board calibrator in sealedreservoir- an electrochemical multi-sensorarray- port for sample introduction- fluid waste chamber			Unit-use cartridge with- on-board calibrator in sealedreservoir- an electrochemical multi-sensorarray- port for sample introduction- fluid waste chamber			same
Test cardstorage	Room temperature until expiry date			Fridge storage until expiry dateincluding max 2 weeks at roomtemperature			different
Sensor arrayTests/sensorcomponents	A laminated foil sensor modulepH - PVC ion selective electrodepCO2 - QH modified SeveringhaustypepO2 - membrane coated gold cathodeNa - PVC ion selective electrodeK - PVC ion selective electrodeiCa - PVC ion selective electrodeHct - conductivity, gold electrodes			A micro-fabricated chip-setpH - PVC ion selective electrodepCO2 - QH modified SeveringhaustypepO2 - membrane coated gold cathodeNa - PVC ion selective electrodeK - PVC ion selective electrodeiCa - PVC ion selective electrodeHct - conductivity, gold electrodes			differentsamesamesamesamesamesame
Analyzercomponents	Two housings:1 - The reader comprising- Orifice for test card introduction- electrical connector to card- heater for 37°C operation- mechanical card engagementdevice for			A single housing comprising- Orifice for test card introduction- electrical connector to card- heater for 37°C operation- mechanical card engagementdevice for			differentsamesamesame

Comparison of Technological Characteristics To Predicate 5.5 Device

Epocal EPOC System 510(k) Submission Appendix 9

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	making electrical contact to card's sensors for rupture of calibrator reservoir moving calibrator to sensors engaging heaters with card -op-amp sensor signal detectorsIQC monitoring devicesThermal controllersMUXA/DBluetooth stack for wireless transmission of digitized raw sensor signals to computing devicebar code scanner for acquiring card infointernal electronic reader self-test circuit2 - The computing device comprising a PDAmicroprocessormemorycolor LCD displaykeyboardi/o for communicating test results to other devicessoftware to control the test and calculate analytical values from raw sensor signalsbattery operated with rechargeable batteries via plug in plug-in power supply	making electrical contact to card's sensors for rupture of calibrator reservoir moving calibrator to sensors engaging heaters with card -op-amp sensor signal detectorsIQC monitoring devicesThermal controllersMUXA/Dwire transmission of digitized raw sensor signals to computing subsystem in same housingn/ainternal and external electronic reader self-test circuitmicroprocessormemorymonochrome LCD displaykeyboardi/o for communicating test results to other devicessoftware to control the test and calculate analytical values from raw sensor signalsbattery operated with rechargeable batteries via external power supply in downloader cradle	samesamesamesamesamesamesamesamedifferentdifferentdifferentsamesamedifferentsamesamesame
Measurementtemperature	37°C	37°C	same
Measurementsequence	Calibrate test card-introduce sample- measure	Introduce sample-calibrate test cartridge-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

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

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

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

Precision 5.6.1

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

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

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

Figure 5.3A – Table – 20 Day Precision Study Data

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

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

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

Epocal EPOC System 510(k) Submission Appendix 9

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

5.6.2 Linearity/Reportable Range

74.6

2.9

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

3.9

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

Figure 5.4 – Table - In House Whole Blood Linearity

5.6.3 Traceability

operator 7

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

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

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

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

5.6.4 Detection Limit

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

5.6.5 Analytical Specificity

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

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

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

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

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

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5.7 Summary of Clinical Tests Submitted in Support of Substantial Equivalence

5.7.1 Method comparison with predicate device

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

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

Figure 5.7 - Table - Method Comparison Summary

Summary of Conclusions Drawn from Non Clinical and 5.8 Clinical Tests

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 7 2006

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

Re: K061597

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

Dear Mr. Layer:

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

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

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

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Page 2 -

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

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Gutz

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

Enclosure

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APPENDIX 10

Indications for Use

510(k) Number (if known): K061597

Device Name: EPOC™ Blood Analysis System

Indications For Use:

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

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

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

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

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

Carol C. Bauer
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of

K06/592

Regulation Number and Section

§ 862.1665 Sodium test system.

(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.