Predicate Devices

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

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard in vitro diagnostic system for measuring lactate in blood. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies focus on traditional analytical metrics like precision, linearity, and method comparison.

Therapeutic

No
The device is described as an "in vitro diagnostic device" and an "in vitro analytical system" intended for "quantitative testing of samples" to "evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis". This indicates it is for diagnostic purposes, not for providing therapy.

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 its measurements are "used in the diagnosis and treatment of lactic acidosis."

SaMD (Software as a Medical Device)

No

The device description clearly outlines a system that includes hardware components such as a test card, a reader, and a mobile computing device (epoc Host). The software is part of a larger hardware system for in vitro diagnostic testing.

IVD (In Vitro Diagnostic)

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

Here's why, based on the provided text:

Intended Use/Indications for Use: Explicitly states the device is "intended for use by trained medical professionals as an in vitro diagnostic device". It also describes the purpose of the test (quantitative testing of blood samples) and how the results are used in diagnosis and treatment.
Device Description: Describes the system as an "in vitro analytical system" that performs "diagnostic testing on whole blood".
Performance Studies: The document details various performance studies, including method comparison with a predicate device, precision studies, linearity, and analytical specificity. These are typical studies required for IVD devices to demonstrate their analytical performance.
Predicate Device: A predicate device (i-Stat™ Lactate Test) is identified, which is common in the regulatory pathway for IVD devices.

The information provided clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Lactate 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, venous or capillary whole blood in the laboratory or at the point of care in hospitals, nursing homes or other clinical care institutions.

Lactate measurements from the epoc Blood Analysis System are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

Product codes

KHP

Device Description

The epoc Lactate 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.

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

Non-Clinical Tests:
Aqueous precision experiments were performed in-house. The results of a twenty day precision study using aqueous controls at two levels L1 and L3 for the blood gases, electrolytes and metabolites are shown. For Lactate, N=320 for both L1 and L3, Mean=7.99 for L1 and 0.94 for L3.
Linearity/Reportable Range 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 an in-house standard method with traceability to NIST standards. Regression analysis was performed as per CLSI EP6-A.
Detection Limit study was performed in-house as per CLSI EP6-A recommendations for evaluation limits of detection and quantification.
Analytical Specificity (Interference testing) was performed in-house on the epoc lactate sensor. A pooled human serum was aliquoted into two samples. The test sample was spiked by addition of interferent, while the control sample was spiked by the addition of the solvent of the interferent. The lactate bias between the mean of six replicates on both the control sample and the test sample with added interferent was calculated.

Clinical Tests:
Method comparison studies were performed in field trials at several hospitals on patient samples of whole blood at various locations (venous, arterial and capillary). The method comparison was against the predicate device. N=373.
Blood precision studies were performed in field trials at two (2) hospitals on volunteer samples of whole blood by potential end users. One (1) sample was obtained and tested fresh (WB L2). Another sample was obtained and held for several hours to increase lactate concentration (WB L1). This sample was introduced via epoc Care-Fill Capillary Tubes.

Aqueous precision studies were performed in field trials by potential end users at two (2) hospitals on commercially available blood gas, electrolytes and metabolites control fluids, L1, L2 and L3 (Eurotrol, The Netherlands).
Matrix Effects: The method comparison studies mentioned above also provided data on matrix effects (venous, arterial, capillary). N=126 for venous, 73 for arterial, 174 for capillary.
Effect of Anticoagulant: Evaluated on patient samples collected using heparinized and non-heparinized devices (43 samples from POC sites of a hospital, 17 samples from in-house studies). Data analyzed using EP9-2A methodology. Total N=60.

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

Aqueous precision:
20-day precision study (in-house) using aqueous controls L1 and L3.
Lactate (mM): N=320 for both L1 and L3. Mean L1=7.99, L3=0.94.
WD CV% L1=4.9%, L3=3.1%. Total CV% L1=6.3%, L3=4.7%.

Linearity/Reportable Range:
In-house study using blood samples (CLSI EP6-A methods). Test Range: 0.3-20.1 mM.

Detection Limit:
In-house study (CLSI EP6-A methods). Low end of reportable range for EPOC lactate test (0.30 mM) is greater than or equal to the limit of detection and statistically discernable from the limit of blank (0.21 mM).

Analytical Specificity:
In-house interference testing on epoc lactate sensor. Unacceptable interference bias defined as a significant error > 5%.
Interferences found: Acetaminophen (above 0.81 mM), Iodide (above 0.67 mM), Bromide (above 25.4 mM), Thiocyanate (above 2.7 mM), N-Acetylcysteine (above 3.7 mM), Glycolic Acid (above 0.87 mM), Glyoxylic Acid (above 0.85 mM).
Insignificant interferences: Acetaminophen (1.66mM), Na ascorbate (630µmol/L), citrate (20mmol/L), L-dopa (100 µmol/L), EDTA (9mmol/L), ethylene glycol (4.84mmol/L), Na fluoride (105 µmmol/L), Methyldopa (71 µmol/L), oxidized glutathione (2.55mmol/L), reduced glutathione (2.55mmol/L), hydroxyurea (132 µmol/L), isoniazide (81 µmol/L), K Oxalate (0.037 mmol/L), Quinidine (0.037 mmol/L), bilirubin conjugated (+342µmol/L), bilirubin unconjugated (+342µmol/L), cholesterol (+13mmol/L), L-cysteine (+1500µmol/L), lipids (+0.8%), pH (+0.4, -0.4), total protein (3% to 10%), Uric Acid (1.4 mM). Low hematocrit (down to 21%) and high hematocrit (up to 61%) did not interfere. Triglycerides (up to 37 mM) did not show significant interference.

Method comparison with Predicate Device:
Field trials at several hospitals on patient samples (N=373) against i-STAT Model 300 Portable Clinical Analyzer.
Slope = 0.967, Intercept = 0.132, R² = 0.9711.
X range: 0.48 - 19.95.

Blood Precision:
Field trials at two hospitals on volunteer whole blood samples by end users.
Site 1: Phlebotomist 1 (N=15, Avg=10.24, SD=0.62, %CV=6.0%), Phlebotomist 2 (N=15, Avg=10.27, SD=0.34, %CV=3.3%) for WB L1.
Site 2: Data table provided but illegible for blood precision.

Aqueous precision (Clinical):
Field trials by end users at two hospitals using commercial control fluids (L1, L2, L3).
Site 1 (Lactate): RN 1 (L3, N=15, Avg=0.95, SD=0.031, %CV=3.3%), Anesthesia Tech (L3, N=15, Avg=0.94, SD=0.027, %CV=2.9%), RN 2 (L2, N=14, Avg=2.88, SD=0.05, %CV=1.8%), Resp Therapist (L2, N=15, Avg=2.91, SD=0.08, %CV=2.8%).
Site 2: Data table provided but illegible for aqueous precision.

Matrix Effects:
Method comparison by sample matrix type (venous, arterial, capillary).
Venous (N=126): Slope=0.937, Intercept=0.211, R²=0.9769.
Arterial (N=73): Slope=1.032, Intercept=-0.165, R²=0.9829.
Capillary (N=174): Slope=0.955, Intercept=0.257, R²=0.9653.
Overall (N=373): Slope=0.967, Intercept=0.132, R²=0.9711.
Consolidated Bias by Sample Matrix Type:
Decision level 2.2mM: Venous Avg Bias=0.073, Arterial Avg Bias=-0.094, Capillary Avg Bias=0.158, All Avg Bias=0.061.
Decision level 5.0mM: Venous Avg Bias=-0.103, Arterial Avg Bias=-0.004, Capillary Avg Bias=0.031, All Avg Bias=-0.031.

Effect of Anticoagulant:
Comparison of heparinized vs. non-heparinized samples (N=60).
Slope = 1.036, Intercept = -0.045, R² = 0.9916.
X range: 0.52 - 11.21.

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

Not Found

Predicate Device(s)

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

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 862.1450 Lactic acid test system.

(a)
Identification. A lactic acid test system is a device intended to measure lactic acid in whole blood and plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

Summary

0

K073257

JUN - 9-2010

ероса

2060 Walkley Road Ottawa Ontario, Canada K1G 3P5

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: k-093297.

Summary Prepared: June 07, 2010

| 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:	Acid, Lactic, Enzymatic Method
Proprietary / Trade Name:	epoc Lactate Test
Common Name:	Lactate acid test system
Classification Name:	Acid, Lactic, Enzymatic Method
Device Classification:	I (Class II with limitation of exemption)
Regulation Number:	862.1450
Panel:	Clinical Chemistry
Product Code:	KHP

Identification of the Predicate Device 5.2

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

Description of the New Device 5.3

The epoc Lactate 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, pCO2, pO2, Glucose and Hematocrit Hct. This submission adds Lactate (Lact) 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℃;
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 displays and stores the blood test results.

Changes to the epoc Blood Analysis System required to introduce the Lactate test include:

Developing a new Lactate 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 use for the Lactate test.

Comparison of Technological Characteristics To Predicate 5.4 Device

510(k) #	epoc Blood Analysis System	i-STAT Model 300	Same / Different
Item	Device	Predicate
Intended use	The Lactate test as part of 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, venous or capillary whole
blood using the BGEM (Blood Gas
Electrolyte and Metabolytes) 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. i-STAT
cartridges comprise a variety of
clinical chemistry tests and test
panels.	same
Where used	hospital	hospital	same

2

| Measured

parameters	pH, pCO2, pO2, Na, K, iCa, Hct, Gluc, Lact		pH, pCO2, pO2, Na, K, iCa, Hct, Gluc, Lact	same
Calculated
parameters	TCO2, HCO3, BE, SO2, Hgb		TCO2, HCO3, BE, SO2, Hgb	same
Sample type	Venous, arterial and capillary whole blood		Venous, arterial and capillary 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
	Gluc	20 - 700
mg/dL	Gluc	20 - 700
mg/dL	same
	Lact	0.3 - 20
mmol/L	Lact	0.3 - 20
mmol/L	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	Non-volumetric over 95 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	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
Glu - glucose oxidase based
amperometric peroxide detection
Lact - lactate oxidase based
amperometric peroxide detection
Hct - conductivity, gold electrodes		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
Glu - glucose oxidase based
amperometric peroxide detection
Lact - lactate oxidase based
amperometric peroxide detection
Hct - conductivity, gold electrodes			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

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 | | A single housing comprising
Orifice for test card introduction
electrical connector to card
heater for 37°C operation
mechanical card engagement device for
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 | | | different |

3

| | 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 | 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 | same
same
different
different
different
same
same |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| | memory
color LCD display | monochrome LCD display | different |
| | keyboard | keyboard | same |
| | i/o for communicating test results | i/o for communicating test results | same |
| | to other devices | to other devices | |
| | software to control the test and
calculate analytical values from
raw sensor signals | software to control the test and
calculate analytical values from
raw sensor signals | same |
| | battery operated with
rechargeable batteries via plug in
plug-in power supply | battery operated with
rechargeable batteries via
external power supply in
downloader cradle | same |
| Measurement
temperature | 37°C | 37°C | same |
| | Measurement Calibrate test card-introduce sample- | Introduce sample-calibrate test | different |
| sequence | measure | cartridge-measure | |
| Measurement
time | 35sec from sample introduction | 200 sec from sample introduction | different |
| Error | iQC system to detect user errors | iQC system to detect user errors | same |
| detection | iQC system for reader self-check | iQC system for reader self-check | same |
| | iQC system to detect card non- | iQC system to detect card non- | same |
| | conformance | conformance | |

Figure 5.1 - 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 5.5 Substantial Equivalence

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

Lactate	All
mM	L1	L3
N	320	320
Mean	7.99	0.94
SWD	0.39	0.03
SDD	0.32	0.03
ST	0.51	0.04
WD CV%	4.9%	3.1%
Total CV%	6.3%	4.7%

Figure 5.2 - Table - 20 Day Precision Study Data

Linearity/Reportable Range 5.5.2

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 an in-house standard method with traceability to NIST standards. Regression analysis was performed as per CLSI EP6-A. The summary is given in the table in Figure 5.3.

| | " est Range "
Slope | | C | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| C
mMl
20.1
ﺗﺄﺳﻴﺴﺎﺕ ﺳﻨﺔ 1999 ﻓﻲ ﺇﺳﺒﺎﻧﻴﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ | .001 | 0.77 | n qaqa
ﻟﻠﺴﻠﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ | |

Figure 5.3 – Table - In House Whole Blood Linearity

5.5.3 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 verification fluids whose concentration values are traceable to NIST standards.

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

5.5.4 Detection Limit

This study was performed in-house as per CLSI EP6-A recommendations for evaluation limits of detection and quantification. The low end of the reportable range for the EPOC lactate test (0.30 mM) is greater than or equal to the limit of detection and is statistically discernable from the limit of blank ( 0.21 mM).

5

Analytical Specificity 5.5.5

Interference testing4 was performed in-house on the epoc lactate sensor. In each of these tests a pooled human serum was aliguoted into two samples. The test sample was spiked by addition of interferent, while the control sample was spiked by the addition of the solvent of the interferent. The lactate bias between the mean of six replicates on both the control sample and the test sample with added interferent was calculated.

Unacceptable interference bias was defined as producing a significant error more than 5% of the time.

Significant interfering substances are itemized below:

· Acetaminophen will have no significant effect up to 0.81 mM after which it will increase the lactate reading up to 306 µM/mM Tylenol. Because the therapeutic upper limit for acetaminophen is 0.20 mM, interfering levels of acetaminophen should only be encountered in overdose situations
· Iodide will decrease the lactate reading up to -1.2mM/mM of Iodide up to an Iodide concentration of 0.67 mM. Above 0.67 mM Iodide the decrease will be -1.2mM.
Bromide will have no significant effect up to 25.4 mM after which it will decrease the lactate reading up to 14.6 µM/mM Bromide.
· Thiocyanate will have no significant effect up to 2.7 mM after which it will decrease the lactate reading by up to 96.6 µM/mM thiocyanate.
N-Acetylcysteine will have no significant effect up to 3.7 mM after which it will decrease the lactate reading by up to 96.3 uM/mM N-Acetylcysteine.

Ethylene glycol ingestion and metabolism has been shown to produce falsely elevated lactate measurements*. Ethylene glycol plus three metabolism products -Glycolic Acid, Glyoxylic Acid and Oxalic Acid - were tested for interference. Ethylene Glycol and Oxalic Acid do not interfere significantly.

· Glycolic Acid will have no significant effect up to 0.87 mM after which it will increase the lactate reading up to 142 µM/mM glycolic acid.
Glyoxylic Acid will have no significant effect up to 0.85 mM after which it will increase the lactate reading up to 373 uM/mM qlyoxylic acid.

CMAJ, April 10, 2007, 176(8), p.1097 "Falsely elevated point-of-care lactate measurement after ingestion of ethylene glycol"

The following levels of exogenous interferences were tested and found to be insignificant: 1.66mM (25mg/dL) acetaminophen, 630µmol/L (12.5mg/dL) Na ascorbate. 20mmol/L (588 mg/dL) citrate. 100 umol/L (~2mg/dL) L-dopa, 9mmol/L (263mg/dL) EDTA, 4.84mmol/L (30mg/dL) ethylene glycol, 105 µmmol/L (0.441mg/dL) Na fluoride, 71 µmol/L Methyldopa, 2.55mmol/L oxidized glutathione, 2.55mmol/L reduced glutathione, 132 umol/L (1.0mg/dL) hydroxyurea, 292µmol/L (4mg/dL) isoniazide (nydrazid), 81 µmol/L (1.5 mg/dL) K Oxalate, 0.037 mmol/L (1.2 mg/dL) Quinidine.

The following levels of endogenous interferences were tested and found to be insignificant: +342µmol/L (+29.0mg/dL) bilirubin conjugated, +342 (+20.1mg/dL) bilirubin unconjuqated, +13mmol/L (+503.1mg/dL) cholesterol, +1500umol/L (+18mg/dL) L-cysteine, +0.8% lipids, pH (+0.4, -0.4), 3% to 10% total protein, 1.4 mM (+ 23.5 mg/dL) Uric Acid.

6

Low hematocrit did not interfere down to a level of 21 % hematocrit and high hematocrit did not interfere up to a level of 61 % hematocrit. Triglycerides did not show significant interference up to a level of 37 mM (1430 ma/dL).

Summary of Clinical Tests Submitted in Support of 5.6 Substantial Equivalence

5.6.1 Method comparison with Predicate Device

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

epoc Lactate vs. i-STAT
N	373
Sxx	0.215
Syy	0.530
intercept	0.132
slope	0.967
Syx	0.948
X min	0.48
X max	19.95
R²	0.9711

Figure 5.6 - Table of Method Comparison Summary against Predicate Device

5.6.2 Blood Precision

Blood precision studies were performed in field trials at two (2) hospitals on volunteer samples of whole blood by potential end users. One (1) sample was obtained and tested fresh (WB L2). Another sample was obtained and held for several hours to increase lactate concentration (WB L1). This sample was introduced via epoc Care-Fill Capillary Tubes.

Site 1

User	QC Level	N	Avg	SD	%CV	lot
Phlebotomist 1	WB L1	15	10.24	0.62	6.0%	09231/09230
Phlebotomist 2	WB L1	15	10.27	0.34	3.3%	09231/09230

Figure 5.7 - Table - Blood Precision Study Summary (Site 1)

Site 2

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Figure 5.8 - Table - Blood Precision Study Summary (Site 2) - Sample Introduced with Capillary Tubes

7

5.6.3 Aqueous precision

Aqueous precision studies were performed in field trials by potential end users at two (2) hospitals on commercially available blood gas, electrolytes and metabolites control fluids, L1, L2 and L3 (Eurotrol, The Netherlands).

Site 1

User	QC Level	N	Avg	SD	%CV	lot
RN 1	L3	15	0.95	0.031	3.3%	09229
Anesthesia Tech	L3	15	0.94	0.027	2.9%	09229
RN 2	L2	14	2.88	0.05	1.8%	09229
Resp Therapist	L2	15	2.91	0.08	2.8%	09229

Figure 5.9 - Table - Aqueous Precision Study Summary (Site 1)

Site 2

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Figure 5.10 - Table - Aqueous Precision Study Summary (Site 2)

Matrix Effects 5.6.4

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

	epoc Lactate vs. i-STAT
	venous	arterial	capillary	all
N	126	73	174	373
Sxx	0.113	0.116	0.290	0.215
Syy	0.586	0.455	0.517	0.530
intercept	0.211	-0.165	0.257	0.132
slope	0.937	1.032	0.955	0.967
Syx	0.750	0.831	1.062	0.948
X min	0.66	0.57	0.48	0.48
X max	19.88	19.95	19.57	19.95
R2	0.9769	0.9829	0.9653	0.9711

Figure 5.11 - Table of Method Comparison Summary Against Predicate Device By Sample Matrix Type

8

	Lactate, mM
matrix	Decision level	2.2	5.0
venous	Average Bias	0.073	-0.103
	95% Confidence Interval ±	0.165	0.113
arterial	Average Bias	-0.094	-0.004
	95% Confidence Interval ±	0.223	0.162
capillary	Average Bias	0.158	0.031
	95% Confidence Interval ±	0.198	0.142
all	Average Bias	0.061	-0.031
	95% Confidence Interval ±	0.119	0.084

Figure 5.12 - Table of Method Comparison Summary Against Predicate Device -Consolidated Bias by Sample Matrix Type

5.6.4.1 Effect of Anticoagulant

The effect of anticoagulant 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 (43 samples) and supplemented with in-house studies (17 samples). The data was analyzed using EP9-2A methodology.

epoc Lactate
No heparin vs. Heparinized
N	60
Sxx	0.091
Syy	0.160
intercept	-0.045
slope	1.036
Syx	0.232
X min	0.52
X max	11.21
R2	0.9916

Figure 5.13 - Table of Heparinized Versus Non-Heparinized Samples

Summary of Conclusions Drawn from Non Clinical and 5.7 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.

9

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/9/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings and tail. The eagle is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.

Epocal, Inc. c/o Mr. Roy Layer Director of Quality Assurance and Regulatory Affairs 2060 Walkley Road Ottawa, Ontario Canada K1G-3P5

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

JUN 0 9 2000

Re: K093297

Trade Name: epoc Lactate test Regulation Number: 21 CFR §862.1450 Regulation Name: Lactic acid test system. Regulatory Class: Class I, meets limitations of exemptions, 21 CFR §862.9 (c)(9) Product Codes: KHP Dated: May 13, 2010 Received: May 17, 2010

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).

10

Page 2

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 (301) 796-5450. 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 (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

CA

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

Enclosure

11

Indication for Use

k = 93297 510(k) Number (if known):

Device Name: epoc Lactate test

Indication For Use:

The Lactate 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, venous or capillary whole blood in the laboratory or at the point of care in hospitals, nursing homes or other clinical care institutions.

Lactate measurements from the epoc Blood Analysis System are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

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)

Carol C. Benson

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

510(k) k 0 93217

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