Who is the manufacturer of EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE?

Epocal, Inc. filed the 510(k) submission for EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE (K093297).

What is the FDA product code for EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE?

KHP. It is classified under 21 CFR 862.1450 as a Class 1 device in the Clinical Chemistry panel.

What is the regulatory pathway for EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE

Q: What are the predicate devices for EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE?

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

K093297 · Epocal, Inc. · KHP · Jun 9, 2010 · Clinical Chemistry

Device Facts

Record ID	K093297
Device Name	EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE
Applicant	Epocal, Inc.
Product Code	KHP · Clinical Chemistry
Decision Date	Jun 9, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1450
Device Class	Class 1

Intended 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 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.)

Device Story

The epoc Lactate Test is an electrochemical sensor added to the existing epoc Blood Analysis System, a point-of-care (POC) diagnostic platform. The system consists of a single-use test card, a portable reader, and a mobile computing device (epoc Host). The user inserts the test card into the reader, which automatically performs calibration, heats the sample to 37°C, and processes the blood sample. The lactate sensor uses an oxidase-based amperometric method to generate electrical signals proportional to lactate concentration. These raw signals are digitized and transmitted wirelessly to the epoc Host, which calculates, displays, and stores the results. The system is operated by trained medical professionals in clinical environments. The output provides quantitative lactate levels, assisting clinicians in evaluating acid-base status and managing lactic acidosis. The device benefits patients by providing rapid, bedside diagnostic information, facilitating timely clinical decision-making.

Clinical Evidence

Clinical evidence includes method comparison studies and precision testing. Method comparison against the predicate (N=373) across venous, arterial, and capillary samples showed high correlation (R²=0.9711, slope=0.967). Precision studies conducted at two hospitals by end-users (RNs, phlebotomists, anesthesia techs) using whole blood and aqueous controls demonstrated acceptable CV% (typically <6.5%). Interference testing confirmed no significant bias from common endogenous/exogenous substances, including hematocrit levels (21-61%) and triglycerides.

Technological Characteristics

Single-use test card with electrochemical multi-sensor array; lactate sensor uses lactate oxidase-based amperometric peroxide detection. System includes reader (heater, A/D converter, Bluetooth) and mobile host (PDA). Operates at 37°C. Connectivity via wireless transmission to host. Calibration is on-board via sealed reservoir. Software-controlled analysis.

Indications for Use

Indicated for trained medical professionals to perform quantitative lactate testing on heparinized or un-anticoagulated arterial, venous, or capillary whole blood samples in clinical settings (hospitals, nursing homes) to evaluate acid-base status and diagnose/treat lactic acidosis.

Regulatory Classification

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).

Predicate Devices

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

Related Devices

K112955 — NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM · Nova Biomedical Corporation · Jan 5, 2012
K980908 — LACTATE PRO SYSTEM · Kdk Corp. · Sep 11, 1998

Submission Summary (Full Text)

{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 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ER ESSEE INVESTIENT FORMER Car | | | | 4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4- A MINILES EN LANDINGER MIRANIL SEMENTE MILLING MALE ( A MIN R LEN & COMMENT IN OR LE | ----------- | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 1 | 1 1. And A CHINESS - A Charles An An- | 1 | പ്രാമം . | | Station of Arms Andrew Associated on Area a And All And יחמם/ S | | A-4-60-100 | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 10727 CAR AN ANNUAL CONNECT CHARACT CHANAL | 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 | ------------------------------------------------------------------------------------------------------------ iser | A STATE CONSULTION CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF C | - Partificant Mitter ------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ -------- | | 01 PM 6 10 % ANNUAL AND AN AND CONSULER OF CONSULER OF CONSULERS OF CONSULERS OF CONSULERS OF CONSULERS OF CONSULERS OF CONSULERS OF CONSULERS OF CONSULERS OF CONSULERS OF CONSULERS OF CO | -------------------------------------- | |----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------| | AND A BOOM A CALL AND C | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 1 | Property Autor | | C 1 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | വാറ്റം at and the last A | | A L & MINNE A ---------------------- 1 ﺮ | | | . | FRANCHILLAND AND AND AND 1 . | 500 I 1 1 100 | uanes سال الساب | 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 Page 1 of 1

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