Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a traditional in vitro diagnostic device with sensors, a reader for signal acquisition, and a host for displaying results. There is no mention of AI, ML, or any algorithms that would suggest their use in data processing or interpretation beyond standard analytical methods.

Therapeutic

No
The device is described as an in vitro diagnostic device used for quantitative testing of blood samples to diagnose and treat diseases. It does not directly provide therapy or treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the system is an "in vitro diagnostic device" and lists its use in the "diagnosis and treatment" of various conditions based on the measurement of specific blood parameters.

SaMD (Software as a Medical Device)

No

The device description clearly outlines three components: a physical test card, a physical card reader, and a PDA with software. While the software is a component, the system relies on dedicated hardware (test card and reader) for sample analysis and data acquisition.

IVD (In Vitro Diagnostic)

Yes, the EPOC Blood Analysis System is an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The document explicitly states the system is "intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of whole blood".
Sample Type: It analyzes "samples of whole blood", which is a biological sample taken from the human body.
Purpose: The measurements of various analytes (Sodium, Potassium, Ionized Calcium, pH, pCO2, pO2, and Hematocrit) are used "in diagnosis and treatment of diseases involving electrolyte imbalance", "diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany", "diagnosis and treatment of life-threatening acid-base disturbances", and to "distinguish normal from abnormal states of blood volume". These are all diagnostic purposes.
Setting: It is used "in the laboratory or at the point of care in hospitals, nursing homes or other clinical care institutions", which are typical settings for IVD testing.

The definition of an IVD device generally includes instruments, reagents, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. The EPOC Blood Analysis System clearly fits this definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

The 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

Product codes

JGS, CEM, JPI, JFP, CHL

Device Description

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

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 or at the 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

Precision:

In-house study: 20-day precision study using aqueous controls at two levels (L1 and L3) for blood gases and electrolytes, and two levels (A and B) for Hematocrit.
Field trials: Experiments at three point-of-care sites with 7 operators performing n=10 replicates on whole blood. Each precision study used 5 different EPOC readers.

Linearity/Reportable Range:

In-house study: Linearity on whole blood versus an in-house standard method with traceability to NIST standards.
Test ranges: pH (6.4-7.9), pCO2 (10-230 mm Hg), pO2 (10-750 mm Hg), K (1.5-12 mmol/L), Na (80-190 mmol/L), iCa (0.6-3.7 mmol/L), Hct (0-75 % PCV).

Traceability:

EPOC System calibration against methods traceable to NIST standards.
Test card on-board calibration material prepared gravimetrically and assayed on reference systems calibrated with traceability to NIST standards.
Calibration verification uses commercially available fluids traceable to NIST standards.
Quality control materials are commercially available fluids with concentrations traceable to NIST standards.

Detection Limit:

Determined by the limits of the reportable range.

Analytical Specificity:

Interference studies performed on the EPOC device. Data presented as interference bias (test result minus control) expressed as a fraction of Total Allowable Error (TE) or as a % bias.
Exogenous interferences: Ethanol, Sodium pentothal, Acetyl salicylate, Ascorbate, Salycilate, Bromide, Iodide, Ibuprofen, Tylenol, Ammonium, Lithium, Halothane.
Endogenous interferences: NaCl, KCl, CaCl2, pH, pCO2, Bicarbonate, Lactate, Hct, Total Protein, Lipids, Cholesterol, Hydroxy butyrate, Cysteine, Bilirubin, NH4, Phosphate.

Method comparison with predicate device:

Field trial at a hospital on patient whole blood samples at point of care settings (intensive care unit, cardiac intensive care unit, hematology/oncology department) and in the central lab.
Patient specimens: arterial, venous, and mixed venous/arterial.
Comparison against the predicate device: i-Stat Model 300 Portable Clinical Analyzer.
N values: pH (149), pCO2 (143), pO2 (142), K (146), Na (156), iCa (156), Hct (142).
R values: pH (0.991), pCO2 (0.990), pO2 (0.978), K (0.993), Na (0.953), iCa (0.985), Hct (0.987).

Key results:

Precision: Demonstrated low %CV values for all analytes across different levels and operators.
Linearity: High R2 values (0.998, 0.999) for all analytes, indicating good linearity across the tested ranges.
Analytical Specificity: Interference data expressed as a fraction of Total Allowable Error.
Method Comparison: High correlation (R values) between the EPOC system and the predicate device, indicating equivalent performance.

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

Not Found

Predicate Device(s)

K001387

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

APPENDIX 9

K061597

e pocal

SEP 27 2006

2935 Conroy Road Ottawa Ontario, Canada K1G 6C6

510(k) SUMMARY

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

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

Summary Prepared: June 7, 2006

Submitted by:	Epocal Inc.
	2935 Conroy Road, Ottawa, Ontario, Canada K1G 6C6
Telephone: (613) 738-6192
Fax: (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 | Regulation
Number | Panel | Product
Code |
|-----------------------------------------------------------------|-------|----------------------|-----------------------|-----------------|
| Electrode, Ion Specific, Sodium | II | 862.1665 | Clinical
Chemistry | JGS |
| Electrode, Ion Specific, Potassium | II | 862.1600 | Clinical
Chemistry | CEM |
| Hematocrit | II | 864.6400 | Hematology | JPI |
| Electrode, Ion Specific, Calcium | II | 862.1145 | Clinical
Chemistry | JFP |
| Electrode Measurement, Blood-
Gases (PCO2, PO2) and Blood pH | II | 862.1120 | Clinical
Chemistry | CHL |

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

1

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

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

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

2

| | EPOC Blood Analysis System | | | | i-STAT Model 300
K001387 | | Same /
Different |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|----------|-----------------------------------------------------------|
| 510(k) #
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 BGE
(Blood Gas Electrolyte) and ABG
(Arterial Blood Gas) 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 | pH, pCO2, pO2, Na, K, iCa, Hct | | | pH, pCO2, pO2, Na, K, iCa, Hct | | | same |
| Calculated
parameters | TCO2, HCO3, BE, SO2, Hgb | | | TCO2, HCO3, BE, SO2, Hgb | | | same |
| Sample type | Venous, arterial whole blood | | | Venous, arterial and skin puncture
whole blood | | | same |
| Reportable
ranges | pH | 6.5 - 8.0 | pH units | pH | 6.5 - 8.2 | pH units | different |
| | pCO2 | 5 - 250 | mm Hg | pCO2 | 5 - 130 | mm Hg | different |
| | pO2 | 5 - 750 | mm Hg | pO2 | 5 - 800 | mm Hg | same |
| | Na | 85 - 180 | mmol/L | Na | 100 - 180 | mmol/L | different |
| | K | 1.5 - 12 | mmol/L | K | 2.0 - 9.0 | mmol/L | different |
| | iCa | 0.25 - 4 | mmol/L | iCa | 0.25 - 2.5 | mmol/L | different |
| | Hct | 10 - 75 | %PCV | Hct | 10 - 75 | %PCV | same |
| | TCO2 | 1 - 85 | mmol/L | TCO2 | 5 - 50 | mmol/L | different |
| | HCO3 | 1 - 85 | mmol/L | HCO3 | 1 - 85 | mmol/L | same |
| | BEecf | -30 - +30 | mmol/L | BEecf | -30 - +30 | mmol/L | same |
| | BEb | -30 - +30 | mmol/L | BEb | -30 - +30 | mmol/L | same |
| | SO2 | 0 - 100 | % | SO2 | 0 - 100 | % | same |
| | Hb | 3.3 - 25 | g/dL | Hb | 3 - 26 | g/dL | same |
| Sample
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
Tests/sensor
components | A laminated foil sensor module
pH - PVC ion selective electrode
pCO2 - QH modified Severinghaus
type
pO2 - membrane coated gold cathode
Na - PVC ion selective electrode
K - PVC ion selective electrode
iCa - PVC ion selective electrode
Hct - conductivity, gold electrodes | | | A micro-fabricated chip-set
pH - PVC ion selective electrode
pCO2 - QH modified Severinghaus
type
pO2 - membrane coated gold cathode
Na - PVC ion selective electrode
K - PVC ion selective electrode
iCa - PVC ion selective electrode
Hct - conductivity, gold electrodes | | | different
same
same
same
same
same
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 | | | A single housing comprising
Orifice for test card introduction
electrical connector to card
heater for 37°C operation
mechanical card engagement
device for | | | different
same
same
same |

Comparison of Technological Characteristics To Predicate 5.5 Device

Epocal EPOC System 510(k) Submission Appendix 9

3

| | making electrical contact to card's sensors for rupture of calibrator reservoir moving calibrator to sensors 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 | making electrical contact to card's sensors for rupture of calibrator reservoir moving calibrator to sensors 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 | same
same
same
same
same
same
same
same
different
different
different
same
same
different
same
same
same |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Measurement
temperature | 37°C | 37°C | same |
| 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 |

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

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

5

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

6

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

7

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

5.6.5 Analytical Specificity

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

| Exogenous

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

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

| Endogenous

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

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

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5.7 Summary of Clinical Tests Submitted in Support of Substantial Equivalence

5.7.1 Method comparison with predicate device

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

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

Figure 5.7 - Table - Method Comparison Summary

Summary of Conclusions Drawn from Non Clinical and 5.8 Clinical Tests

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 7 2006

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

Re: K061597

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

Dear Mr. Layer:

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

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

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

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

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

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

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

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

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

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

Carol C. Bauer
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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