EPOC CHLORIDE TEST AND EPOC CREATININE TEST
Device Facts
| Record ID | K113726 |
|---|---|
| Device Name | EPOC CHLORIDE TEST AND EPOC CREATININE TEST |
| Applicant | Epocal, Inc. |
| Product Code | CGL · Clinical Chemistry |
| Decision Date | Oct 5, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1225 |
| Device Class | Class 2 |
Intended Use
The Creatinine 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. Creatinine measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of certain renal diseases and in monitoring renal dialysis. The Chloride 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. Chloride measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of electrolyte and metabolic disorders.
Device Story
The epoc Blood Analysis System is a point-of-care (POC) diagnostic platform consisting of a reader and single-use test cards. This submission adds chloride and creatinine sensors to the existing card. The user inserts the card into the reader, which automatically performs calibration, heats the measurement region to 37°C, and opens fluidic valves. The user introduces a whole blood sample; sensors generate electrical signals proportional to analyte concentrations. Data is transmitted wirelessly to an epoc Host (mobile computing device) for display and storage. The system calculates additional values including Anion Gap and eGFR (MDRD type). Results assist clinicians in diagnosing electrolyte/metabolic disorders and renal disease. The system is intended for use by trained medical professionals in clinical settings.
Clinical Evidence
Clinical field trials were conducted at two hospitals comparing the epoc System against predicate and comparative devices using venous, arterial, and capillary whole blood samples. Method comparison for chloride (N=155 vs. i-STAT) showed R²=0.98 and mean bias of -1.0 mM at 112 mM. Creatinine comparison (N=144 vs. Roche Cobas) showed R²=0.99 and mean bias of -0.06 mg/dL at 1.25 mg/dL. Precision studies (aqueous and whole blood) were performed across multiple sites by various end-users (RNs, technicians, phlebotomists), demonstrating acceptable CV% across clinical ranges.
Technological Characteristics
Unit-use test card with fluidic housing, electrochemical multi-sensor array, and on-board calibration fluid. Chloride: ion-selective electrode. Creatinine: three-layer enzyme electrode (Creatinine Amidohyrdolase, Creatine Amidinohydrolase, Sarcosine Oxidase) with gold electrode. Measurement temperature 37°C. Connectivity: epoc Blood Analysis System reader. Software: embedded application for signal processing and e-GFR calculation.
Indications for Use
Indicated for trained medical professionals to perform quantitative testing of chloride and creatinine in heparinized or un-anticoagulated arterial, venous, or capillary whole blood. Used for diagnosis/treatment of renal diseases, monitoring renal dialysis, and managing electrolyte/metabolic disorders.
Regulatory Classification
Identification
A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
Predicate Devices
- i-Stat™ Chloride using i-Stat™ Model 300 Portable Clinical Analyzer (K001387)
- Roche Cobas c 511/512 CREP2 Creatinine Plus ver. 2 assay (K024098)
Related Devices
- K171247 — epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test · Epocal, Inc. · Jan 17, 2018
- K090109 — BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD · Epocal, Inc. · Jun 24, 2009
- K061597 — EPOC BLOOD ANALYSIS SYSTEM · Epocal, Inc. · Sep 27, 2006
- K070068 — NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS · Nova Biomedical Corp. · May 7, 2007
Submission Summary (Full Text)
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# еросаl
2060 Walkley Road Ottawa Ontario, Canada K1G 3P5
OCT 5 2012
1
# 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: K113726
Summary Prepared: July 28, 2012 Submitted by: Epocal Inc. 2060 Walkley Road, Ottawa, Ontario, Canada K1G 3P5 Telephone: (613) 738-6192 Fax: (613) 738-6195 Contact: Roy Layer Vice President, Quality Assurance & Regulatory Affairs. 5.1 Identification of the Device(s) Common Name: Creatinine Test epoc™ Creatinine Test Trade Name: Classification Name: electrode, ion based, enzymatic, creatinine Device Classification: 2 Requlation Number: 862.1225 Clinical Chemistry Panel: Product Code: CGL Common Name: Chloride Test epoc™ Chloride Test Trade Name: Classification Name: electrode, ion-specific, chloride Device Classification: 2 Regulation Number: 862.1170 Panel: Clinical Chemistry Product Code: CGZ
#### 5.2 Identification of Predicate Devices
- i-Stat™ Chloride using i-Stat™ Model 300 Portable Clinical Analyzer .
- . Roche Cobas c 511/512 CREP2 Creatinine Plus ver. 2 assay
#### 5.3 Description of the New Device
The epoc Chloride and Creatinine tests are being added as additional sensors 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.
epoc Creatinine & Chloride Tests - 510(k) Submission Section 05 - Page 1 of 16
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The epoc Blood Analysis System is an in vitro analytical system comprising a network of one or more epoc Readers designed to be used at the point of care (POC). The readers accept an epoc single use test card containing a group of sensors that perform diagnostic testing on whole blood. The blood test results are transmitted wirelessly to an epoc Host, which displays and stores the test results.
The 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, Lactate, Glucose and Hematocrit Hct. This submission adds Chloride and Creatinine to this list of approved tests.
To perform a blood test, a new test card is inserted into a card reader's card slot with white label face down. When fully inserted, the test card is automatically engaged in the reader.
The card insertion process:
- Brings the cards sensor module into contact with the reader's electrical contact . array:
- . Brings the card's measurement region, which is the fluidic channel above the sensor array, into thermal contact with the reader's heater assembly for heating the measurement region to 37°C;
- . Actuates the opening of the fluidic valve in the card and causes delivery of calibrator fluid from the reservoir to the measurement region.
After calibration, and upon a prompt by the reader (LED visual and audio beep), the user introduces a blood sample for measurement through the blood sample port to the card's measurement region. When sensors are contacted by the blood sample they generate electrical signals proportional to analyte concentrations in the blood sample, which are transmitted wirelessly by the Reader to the epoc Host. The epoc Host displays and stores the blood test results.
The epoc Host will also display calculated values based on the new analytes:
Anion Gap: AGap = (Na+) - (CI- + cHCO3-)
Anion Gap, K: AGapK = (Na+ + K+) - (CI- + cHCO3-)
Estimated Glomerular Filtration Rate (IDMS-traceable MDRD type): eGFR = 175 x (Crea-1.154) x (Age-0.203) x (0.742 if female, 1 if male)
Estimated Glomerular Filtration Rate, if African American (IDMStraceable MDRD type):
eGFR-a = 175 x (Crea-1.154) x (Age-0.203) x (0.742 if female, 1 if male) x 1.212
Crea concentration is in units of mg/dL. Age and gender ("M" or "F") are user inputs. eGFR, eGFR-a are both reported on the epoc System. eGFR, eGFR-a values are not reported if age is less that 18 years old or greater than 70 years old.
Numeric values will be reported for values between 2-60 mL/min/1.73 m². Values >60 will be reported as > 60 mL/min/1.73 m². This range is based on the specific National Kidney Disease
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Education Program (NKDEP) recommendation for reporting eGFR the following web link: values. Please refer to http://nkdep.nih.qov/lab-evaluation/gfr/reporting.shtml.
The following additional statement appears in our labeling: eGFR > 60 does not exclude the possibility of mild renal disease. Further laboratory testing may be necessary to distinguish normal renal function from mild renal disease.
Addition of the epoc Chloride and Creatinine tests comprises three (3) changes to the epoc System:
- 1. Addition of the new sensors on the test card (described below);
- 2. Modification of the epoc System software application to accommodate the new tests (refer to Section 16 - Software);
- 3. Labeling changes including indications for use (refer to Section 04 Indications for Use Statements and Section 13 - Proposed Labeling and Packaging),
#### 5.4 Comparison of Characteristics To Predicate Devices
Tables Figures 5.1 and 5.2 itemize key characteristics of the epoc chloride and creatinine tests as part of the epoc device and their respective predicate devices. The chloride and creatinine tests are an addition to the previously cleared system. All other system features are the same as previously submitted on k061597, k090109 and k093297.
| | epoc Blood Analysis System | i-STAT Model 300 | Same / Different |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| 510(k) # | k113726 | K001387 | |
| Item | Device | Predicate | |
| Intended use | The Chloride test, as part of the epoc<br>Blood Analysis System, is intended for<br>use by trained medical professionals as<br>an in vitro diagnostic device for the<br>quantitative testing of samples of<br>heparinized or un-anticoagulated<br>arterial, venous or capillary whole blood<br>in the laboratory or at the point of care.<br>Chloride measurements from the epoc<br>Blood Analysis System are used in the<br>diagnosis and treatment of electrolyte<br>and metabolic disorders. | The test for chloride, as part of the i-STAT<br>System, is intended for use in the in vitro<br>quantification of chloride in arterial,<br>venous, or capillary whole blood.<br>Chloride measurements are primarily<br>used in the diagnosis, monitoring, and<br>treatment of electrolyte and metabolic<br>disorders including, but not limited to,<br>cystic fibrosis, diabetic acidosis, and<br>hydration disorders. | similar |
| Where used | hospital, point of care | hospital, point of care | same |
| Sample type | Venous, arterial and capillary whole<br>blood | Venous, arterial and capillary whole blood | same |
| Reportable<br>range | 65 - 140 mmol/L | 65 - 140 mmol/L | same |
| Detection<br>principle | The epoc Chloride test relies on ion<br>selective membrane potentiometry. | The i-STAT Chloride test relies on ion<br>selective membrane potentiometry. | same |
| Sample<br>volume | At least 92 uL | 100μL | same |
Figure 5.1 - Table Comparing epoc Chloride Test Characteristics with Predicate Device
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| | epoc Blood Analysis System | Roche Cobas |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) # | k113726 | K024098 |
| Item | Device | Predicate |
| Intended use | The Creatinine test, as part of the epoc<br>Blood Analysis System, is intended for<br>use by trained medical professionals as<br>an in vitro diagnostic device for the<br>quantitative testing of samples of<br>heparinized or un-anticoagulated<br>arterial, venous or capillary whole blood<br>in the laboratory or at the point of care .<br>Creatinine measurements from the epoc<br>Blood Analysis System are used in the<br>diagnosis and treatment of certain renal<br>diseases and in monitoring renal<br>dialysis. | In vitro assay for the quantitative<br>determination of creatinine in human<br>serum, plasma and urine on Roche<br>automated clinical chemistry analyzers. |
| Where used | hospital, point of care | hospital, laboratory |
| Sample type | Venous, arterial and capillary whole<br>blood | Serum, Plasma, Urine |
| Reportable<br>range | 0.3 - 15.0 mg/dL | 0.03 - 30 mg/dL |
| Detection<br>principle | The epoc Creatinine test relies on<br>enzymatic cascade reaction<br>(creatininase, creatinase, sarcosine<br>oxidase) leading to amperometric<br>peroxide detection. | The Roche Creatinine test relies on an<br>enzymatic cascade reaction (creatininase,<br>creatinase, sarcosine oxidase) leading to<br>peroxidase-catalyzed chromogenic<br>peroxide detection. |
| Sample<br>volume | At least 92 uL | 2-5 uL |
Figure 5.2 - Table Comparing epoc Creatinine Test Characteristics with Predicate Device
## 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 3 lots using aqueous controls at two levels L1 and L3 for the blood gases, electrolytes and metabolytes.
| | All lots | | | All lots | |
|---------------|----------|-------|--------------------|----------|-------|
| Chloride [mM] | L1 | L3 | Creatinine [mg/dL] | L1 | L3 |
| N | 240 | 240 | N | 239 | 241 |
| Mean | 76.9 | 125.0 | Mean | 0.71 | 5.50 |
| SWD | 0.35 | 0.61 | SWD | 0.030 | 0.197 |
| SDD | 0.18 | 0.61 | SDD | 0.017 | 0.112 |
| ST | 0.39 | 0.86 | ST | 0.035 | 0.226 |
| WD %CV | 0.5% | 0.5% | WD %CV | 4.2% | 3.6% |
| Total %CV | 0.5% | 0.7% | Total %CV | 4.9% | 4.1% |
Figure 5.3 - Table - 20 Day Precision Study Data
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#### 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.
| r<br>AND ARRANTHISAN IN CHARACT OF CHARACTER OF CHARACT TO COLLECTION<br>And In a first of the county of the county | | | | |
|---------------------------------------------------------------------------------------------------------------------|----------|------|-----|--|
| Range<br>2. 24 | 1006 | merc | | |
| | ﺎ ﺍﻟﻤﻠﻜﺔ | | 000 | |
| Creatinine<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|-----------|------|--|
| Test Range | Slope | Intercept | n2 | |
| 0.25 - 15.5 mg/dL | 1.00 | 0.07 | 0.99 | |
Figure 5.3 - Table - In House Whole Blood Linearity
This data supports the claimed reportable ranges of 65-140 mM for Chloride and 0.3 - 15.00 mg/dL for Creatinine.
#### 5.5.3 Traceability
Chloride ion concentration values assigned to controls and calibrator fluids are traceable to NIST standards.
Creatinine concentration values assigned to controls and calibrator fluids are traceable to NIST standard SRM 967. The epoc Creatinine test is calibrated to an IDMS-traceable whole blood method and reports plasma equivalent concentrations.
### 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 chloride test (65 mM) and the epoc creatinine test (0.30 mg/dL) are greater than or equal to the limit of detection and are statistically discernable from the limit of blank.
### 5.5.5 Analytical Specificity
Interference testing based on CLSI "Interference Testing in Clinical Chemistry; Approved Guideline", CLSI document EP7-A2. was performed in-house on the epoc chloride and creatinine sensors. In each of these tests a pooled human serum was aliquoted into two (2) 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 bias between the mean of six replicates on both the control sample and the test sample with added interferent was calculated. The concentration of interfering substance considered as causing no clinically significant interference is defined as a bias (difference between the test and the control sample) of:
≤ 0.2 mg/dL for creatinine concentrations ≤2 mg/dL and ≤7.9% for creatinine concentrations >2 mg/dL :
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≤ 4.2% for chloride concentrations ≤125 mM and ≤5.2% for chloride concentrations >125 mM.
Clinically significant interfering substances for chloride are itemized below:
- ß-Hydroxybutyrate will have no significant effect up to 6.46 mM (67.2 . mg/dL) after which it will increase the chloride reading by up to 0.63 mM/mM ß-Hydroxybutyrate.
- . Bromide will have no significant effect up to 3.43 mM after which it will increase the chloride reading up to 9.36 mM/mM Bromide.
- Citrate will have no significant effect up to 2.36 (45.3 mg/dL) mM after . which it will increase the chloride reading by up to 1.37 mM /mM Citrate.
- N-Acetylcysteine will have no significant effect up to 2.85 mM (46.4 � mg/dL) after which it will decrease the chloride reading by up to 1.34 mM/mM N-Acetvlcvsteine.
- Salicylic acid will have no significant effect up to 2.55 mM (41 mg/dL) . after which it will increase the chloride reading up to 1.66 mM/mM Salicylic acid.
- Thiocyanate will have no significant effect up to 2.50 (14.5 mg/dL) mM ● after which it will increase the chloride reading up to 1.66 mM/mM Thiocyanate.
The following levels of exogenous interferences were tested and found to be clinically insignificant:
1.324 mmol/L (20 mg/dL) acetaminophen, 3.62 mmol/L (65.2 mg/dL) acetylsalicy/ic acid, 342 µmol/L (6.8 mg/dL) Na ascorbate, 3.4 µmol/L (0.1 mg/dL) EDTA, 71 umol/L methyIdopa, 2.55 mmol/L (156 mg/dL) oxidized glutathione, 132 µmol/L (1.0mg/dL) hydroxyurea, 292 umol/L (4mg/dL) isoniazid (nydrazid), +0.8% intralipid, 3 µmol/L (0.1 mg/dL) dobutamine, 5.87 µmol/L (0.1 mg/dL) dopamine, 86.8 mmol/L (400 mg/dL) ethanol, 105 µmol/L (0.44 mg/dL) fluoride, 133 µmol/L (0.4 mg/dL) formaldehyde, 55 mmol/L (990 mg/dL) glucose, 0.4 mmol/L (5 mg/dL) guaiacol, 3000 U/L heparin, 2.43 mmol/L (50 mg/dL) ibuprofen, 0.1 mmol/L (2.0 mg/dL) L-Dopa, 51.2 µmol/L (1.2 mg/dL) lidocaine, 71 µmol/L (1.7 mg/dL) 2.37 mmol/L (64 mg/dL) methyldopa, 354 µmol/L (9.4 mg/dL) pentathol, tolbutamide, 2.99 mmol/L (49.6 mq/dL) Iodide.
The following levels of endogenous interferences were tested and found to be clinically insignificant:
+342 umol/L (+20.1mg/dL) bilirubin unconjugated, +342 umol/L (28.8 mg/dL) bilirubin conjugate, +382 µmol/L (5.0 mg/dL) creatine, 102 mmHg CO2, 13 mmHg CO2 + 40 mmol/L bicarbonate , pH >8.0, pH < 6.8, 24%- 66% hematocrit, <6.0% protein,>8.0% protein, 1.4 mmol/L (23.5 mg/dL) uric acid. 6.6 mmol/L (74 mg/dL) lactate, 122 mmHg O2, 28 mmHg O2, 0.25 mmol/L (2.9 mg/dL) proline, 1 µmol/L (0.01 mg/dL) sarcosine, 42.9 mmol/L (258 mg/dL) urea.
Clinically significant interfering substances for creatinine are itemized below:
- । Creatine will have no significant effect up to 116 µmol/L (1.52 mg/dL) after which it will increase the creatinine concentration by up to 0.0025 mg/dL creatinine per umol/L creatine. The normal range of creatine in plasma is 8 -31 umol/L (0.1- 0.4 mg/dL) in males and 15 - 53 µmol/L (0.2 - 0.7 mg/dL) in females '3.
- Bilirubin conjugate will have no significant effect up to 104 µmol/L -(8.76 mg/dL) after which it will decrease the creatinine concentration by up to
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0.002 mg/dL creatinine per umol/L bilirubin conjugate. The normal range of bilirubin conjugate is 0 - 3.4 umol/L (0 - 0.2 mg/dL) 2.
- Bromide will have no significant effect up to 17.9 mmol/L after which it will decrease the creatinine concentration by up to 0.014 mg/dL creatinine per mmol/L bromide.
- Thiocyanate will have no significant effect up to 0.93 mmol/L (5.41 mg/dL) after which it will decrease the creatinine concentration by up to 0.142 mg/dL creatinine per mmol/L thiocyanate.
- Citrate will have no significant effect up to 19.9 mmol/L (382.1 mg/dL) after which it will decrease the creatinine concentration by up to 0.026 mg/dL creatinine per mmol/L citrate.
- Iodide will have no significant effect up to 0.007 mmol/L iodide (0.089 mg/dL) after which it will decrease the creatinine concentration by up to 28 mq/dL creatinine per mmol/L iodide.
- N-acetyl cysteine will have no significant effect up to 820 umol/L (13.35 mg/dL) after which it will decrease the creatinine concentration by up to 0.26 mq/dL creatinine per mmol/L N-acetyl cysteine. It has been reported that 1 mM N-acetyl cysteine is therapeutically unattainable in plasma8. The therapeutic level for N-acetyl cysteine is 0.3 mM16.
The following levels of exogenous interferences were tested and found to be clinically insignificant:
1.324 mmol/L (20 mg/dL) acetaminophen, 3.62 mmol/L (65.2 mg/dL) acetylsalicy/ic acid, 5 µmol/L (0.7 mq/dL) bacitractin, 30.2 µmol/L (1 mg/dL) ciprofloxacin, 48.6 µmol/L (1.75 mg/dL) Levofloxaxin, 342 µmol/L (6.8 mg/dL) Na ascorbate, 100 μmol/L {~2mg/dL) L-dopa, 3.4 µmol/L (0.1 mg/dL) EDTA, 105 µmol/L (0.441mg/dL) Na fluoride, 71 µmol/L (1.7 mg/dL) methyldopa, 2.55 mmol/L (156 mg/dL) oxidized glutathione, 2.55 mmol/L (78 mg/dL) reduced glutathione, 920 µmol/L (6.96 mg/dL) hydroxyurea, 292 µmol/L (4mg/dL) isoniazide (nydrazid), +0.8% (800 mg/dL) intralipid, 3 umol/L (0.1 mq/dL) dobutamine, 5.87 umol/L (0.1 mg/dL) dopamine, 86.8 mmol/L (400 mg/dL) ethanol, 133 µmol/L (0.4 mg/dL) formaldehyde, 55 mmol/L (990 mg/dL) glucose, 0.4 mmol/L (5 mg/dL) guaiacol, 3000 U/L heparin, 2.43 mmol/L (50 mg/dL) ibuprofen, 78.1 µmol/L (6.42 mg/dL) rifampicin, 51.2 umol/L (1.2 mq/dL) lidocaine, 354 µmol/L (9.4 mg/dL) pentathol, 4.34 mmol/L (70 mg/dL) salicylate, 2.37 mmol/L (64 mg/dL) tolbutamide.
The following levels of endogenous interferences were tested and found to be clinically insignificant:
+342 µmol/L (+20.1mg/dL) bilirubin unconjugated, 100.26 mmHg CO2, 15.5 mmHg C02, + 48.2 mmol/L Bicarbonate , pH >8.0, pH < 6.8, 24% - 66% Hematocrit, <6.0% Protein, >8.0% Protein, 1.4 mmol/L (23.5 mg/dL) Uric Acid. 6.6 mmol/L (74 mg/dL) lactate, 132 mmHg 02, 22 mmHg 02, 0.25 mmol/L (2.9 mg/dL) proline, 1 µmol/L (0.01 mg/dL) sarcosine, 10.0 mmol/L (104 mg/dL)
ß-hydroxybutyrate, 42.9 mmol/L (258 mg/dL) urea.
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## Summary of Clinical Tests Submitted in Support of 5.6 Substantial Equivalence
## 5.6.1Method comparison with Predicate and Comparative Devices
We have performed side-by-side comparisons of the epoc System with the predicate devices and other comparative devices in clinical field trials. Venous, arterial, capillary samples were tested by a variety of potential end users. Multiple card lots and multiple epoc system readers and host computers were employed.
Method comparison studies for chloride were performed at two hospitals. Venous samples were compared with 2 non-point-of-care systems (2 serum methods). Venous, arterial and capillary patient samples were compared with a whole blood point-of-care system. Consolidated method comparison data versus the predicate device and comparative instruments are summarized in the tables 5.5 below.
| | non-POC Systems* | Abbott i-STAT† |
|---------------------|------------------|----------------|
| N | 96 | 155 |
| Sxx | 0.6 | 0.9 |
| Syy | 0.6 | 0.8 |
| slope | 0.90 | 0.99 |
| intercept | 9.38 | 0.20 |
| Syx | 2.1 | 1.9 |
| X min | 71 | 69 |
| X max | 142 | 139 |
| R2 | 0.96 | 0.98 |
| Mean Bias at 112 mM | -1.3 | -1.0 |
Figure 5.5 – Table – Chloride Method Comparison Data
* Pooled venous sample data. Approximate equal number vs. Roche Cobas 6000, Siemens Advia + Patient samples approximately equal numbers of venous, arterial and capillary samples versus Abbott i-STAT 300
Method comparison studies were performed at a hospital site comparing venous, arterial and capillary patient samples with a serum-based laboratory method. Consolidated method comparison data versus the predicate device are summarized in the tables 5.6 below.
| Roche Cobas 6000* | |
|-------------------------|-------|
| N | 144 |
| Sxx | 0.10 |
| Syy | 0.30 |
| slope | 1.03 |
| intercept | -0.10 |
| Syx | 0.45 |
| X min | 0.30 |
| X max | 14.80 |
| R2 | 0.99 |
| Mean Bias at 1.25 mg/dL | -0.06 |
Figure 5.6 – Table – Creatinine Method Comparison Data
* Patient samples approximately equal numbers of venous, arterial and capillary samples
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## 5.6.2 Blood Precision
Whole blood precision studies were performed at clinical sites to demonstrate precision when analyzed by end users. Normal and spiked level samples were tested injected by both syringes and capillary tubes.
| User | QC Level | N | Mean | SD | %CV | Lot |
|---------------------------|----------------|----|--------|------|------|-------------|
| Special Care Nursery RN 1 | Normal syringe | 10 | 102.11 | 1.01 | 1.0% | 08-11250-00 |
| Special Care Nursery RN 2 | Normal syringe | 10 | 102.58 | 0.53 | 0.5% | 08-11244-00 |
| Labor & Delivery RN 1 | Normal syringe | 9 | 108.80 | 1.25 | 1.2% | 08-11243-00 |
| Labor & Delivery RN 2 | Normal syringe | 10 | 109.10 | 0.99 | 0.9% | 08-11244-00 |
| Special Care Nursery RN 1 | Spiked syringe | 10 | 111.97 | 0.51 | 0.5% | 08-11250-00 |
| Special Care Nursery RN 2 | Spiked syringe | 10 | 112.29 | 0.66 | 0.6% | 08-11243-00 |
| Labor & Delivery RN 1 | Spiked syringe | 10 | 114.99 | 0.95 | 0.8% | 08-11243-00 |
| Labor & Delivery RN 2 | Spiked syringe | 10 | 114.18 | 0.49 | 0.4% | 08-11250-00 |
Figure 5.7 – Table – Chloride Blood Precision Site 1
| User | QC Level | N | Mean | SD | %CV | Lot |
|-------------------------|------------------|----|--------|------|------|-------------|
| Respiratory Therapist 1 | Normal syringe | 10 | 107.43 | 0.34 | 0.3% | 08-11250-00 |
| Client Services Rep | Normal syringe | 11 | 105.93 | 0.41 | 0.4% | 08-11243-00 |
| Anesthesia Tech 1 | Normal syringe | 10 | 105.81 | 0.39 | 0.4% | 08-11244-00 |
| Phlebotomist 1 | Normal syringe | 10 | 109.31 | 0.31 | 0.3% | 08-11243-00 |
| OP Surgery Tech 1 | Normal syringe | 10 | 106.46 | 0.40 | 0.4% | 08-11243-00 |
| OP Surgery Tech 2 | Normal syringe | 10 | 107.43 | 0.83 | 0.8% | 08-11243-00 |
| Phlebotomist 2 | Normal syringe | 10 | 104.57 | 0.33 | 0.3% | 08-11243-00 |
| Phlebotomist 3 | Normal syringe | 10 | 107.16 | 0.79 | 0.7% | 08-11245-00 |
| Respiratory Therapist 1 | Spiked syringe | 10 | 135.18 | 0.74 | 0.5% | 08-11243-00 |
| Client Services Rep | Spiked syringe | 10 | 131.07 | 0.75 | 0.6% | 08-11250-00 |
| Anesthesia Tech 1 | Spiked syringe | 10 | 131.27 | 1.79 | 1.4% | 08-11243-00 |
| Phlebotomist 1 | Spiked syringe | 10 | 136.25 | 1.55 | 1.1% | 08-11250-00 |
| OP Surgery Tech 1 | Spiked syringe | 10 | 115.86 | 0.37 | 0.3% | 08-11243-00 |
| OP Surgery Tech 2 | Spiked syringe | 10 | 115.87 | 1.19 | 1.0% | 08-11245-00 |
| Phlebotomist 2 | Spiked syringe | 10 | 115.15 | 0.55 | 0.5% | 08-11243-00 |
| Phlebotomist 3 | Spiked syringe | 10 | 117.12 | 0.81 | 0.7% | 08-11245-00 |
| Client Services Rep | Normal capillary | 10 | 106.31 | 0.56 | 0.5% | 08-11250-00 |
| Anesthesia Tech 1 | Normal capillary | 10 | 107.22 | 0.75 | 0.7% | 08-11244-00 |
| OP Surgery Tech 1 | Normal capillary | 10 | 106.74 | 0.84 | 0.8% | 08-11244-00 |
| Phlebotomist 2 | Normal capillary | 10 | 105.21 | 0.66 | 0.6% | 08-11243-00 |
| Client Services Rep | Spiked capillary | 10 | 131.32 | 2.10 | 1.6% | 08-11250-00 |
| Anesthesia Tech 1 | Spiked capillary | 10 | 132.08 | 1.11 | 0.8% | 08-11244-00 |
| OP Surgery Tech 1 | Spiked capillary | 10 | 115.19 | 0.88 | 0.8% | 08-11244-00 |
| Phlebotomist 2 | Spiked capillary | 10 | 114.82 | 0.34 | 0.3% | 08-11243-00 |
Figure 5.8 - Table - Chloride Blood Precision Site 2
{9}------------------------------------------------
| User | Site | Sample | N | Mean | SD | %CV | Lot |
|-------------------------|------|------------------|----|------|------|-------|----------------------------------------|
| Medical Technician 1 | 1 | Normal syringe | 10 | 0.64 | 0.03 | 5.3% | 07-12137-00 |
| Medical Technician 2 | 1 | Normal syringe | 10 | 0.69 | 0.07 | 9.7% | 07-12137-00 |
| Phlebotomist 1 | 2 | Normal syringe | 10 | 0.62 | 0.05 | 8.7% | 07-12144-00 |
| Phlebotomist 2 | 1 | Normal syringe | 10 | 0.56 | 0.05 | 8.6% | 07-12136-00 |
| Phlebotomist 3 | 2 | Normal syringe | 10 | 0.59 | 0.04 | 7.4% | 07-12132-00 |
| Phlebotomist 4 | 2 | Normal syringe | 10 | 0.65 | 0.05 | 7.7% | 07-12137-00 |
| Phlebotomist 5 | 2 | Normal syringe | 10 | 0.68 | 0.07 | 10.1% | 07-12144-00 |
| Respiratory Therapist 1 | 3 | Normal syringe | 9 | 0.64 | 0.03 | 4.3% | 07-12136-00 |
| Respiratory Therapist 2 | 3 | Normal syringe | 10 | 0.63 | 0.05 | 8.0% | 07-12132-00 |
| Respiratory Therapist 3 | 3 | Normal syringe | 10 | 0.48 | 0.04 | 8.8% | 07-12144-00 |
| Respiratory Therapist 4 | 3 | Normal syringe | 10 | 0.43 | 0.02 | 3.6% | 07-12132-00 |
| Specimen processor | 1 | Normal syringe | 9 | 0.63 | 0.05 | 8.1% | 07-12144-00 |
| Medical Technician 1 | 1 | Spiked syringe | 10 | 1.70 | 0.09 | 5.2% | 07-12144-00 |
| Medical Technician 2 | 1 | Spiked syringe | 10 | 1.60 | 0.06 | 3.9% | 07-12144-00 |
| Phlebotomist 1 | 2 | Spiked syringe | 9 | 1.61 | 0.10 | 6.1% | 07-12137-00 |
| Phlebotomist 2 | 1 | Spiked syringe | 10 | 1.50 | 0.03 | 1.7% | 07-12132-00 |
| Phlebotomist 3 | 2 | Spiked syringe | 10 | 1.52 | 0.05 | 3.1% | 07-12136-00 |
| Phlebotomist 4 | 2 | Spiked syringe | 10 | 1.58 | 0.05 | 3.4% | 07-12144-00 |
| Phlebotomist 5 | 2 | Spiked syringe | 10 | 1.48 | 0.05 | 3.7% | 07-12137-00 |
| Respiratory Therapist 1 | 3 | Spiked syringe | 10 | 1.47 | 0.07 | 4.9% | 07-12132-00 |
| Respiratory Therapist 2 | 3 | Spiked syringe | 9 | 1.51 | 0.06 | 4.2% | 07-12136-00 |
| Respiratory Therapist 3 | 3 | Spiked syringe | 10 | 1.69 | 0.03 | 1.6% | 07-12137-00 |
| Respiratory Therapist 4 | 3 | Spiked syringe | 10 | 1.58 | 0.05 | 3.2% | 07-12144-00 |
| Specimen processor | 1 | Spiked syringe | 10 | 1.61 | 0.10 | 5.9% | 07-12137-00 |
| Phlebotomist 1 | 2 | Normal capillary | 10 | 0.50 | 0.05 | 9.5% | 07-12144-00 |
| Phlebotomist 6 | 2 | Normal capillary | 9 | 0.55 | 0.04 | 6.5% | 07-12144-00 |
| Specimen processor | 1 | Normal capillary | 10 | 0.52 | 0.02 | 4.3% | 07-12132-00 (n=7)<br>07-12136-00 (n=3) |
| Phlebotomist 1 | 2 | Spiked capillary | 10 | 1.42 | 0.07 | 5.1% | 07-12132-00 |
| Phlebotomist 6 | 2 | Spiked capillary | 10 | 1.43 | 0.05 | 3.4% | 07-12136-00 |
| Specimen processor | 1 | Spiked capillary | 10 | 1.52 | 0.05 | 3.4% | 07-12144-00 |
Figure 5.9 – Table – Creatinine Blood Precision
-
11. 11. 11.
.
:
:
:
:
.......
.
:
{10}------------------------------------------------
| Chloride | | | | |
|-----------------------|-------------|-------------|-------------|-------------|
| All Users - All Sites | Normal | Spiked | Normal | Spiked |
| Whole Blood | Syringe | Syringe | Capillary | Capillary |
| N - Tests | 120 | 119 | 40 | 40 |
| N - Runs | 12 | 12 | 4 | 4 |
| N - Replicates | 10 | 10 | 10 | 10 |
| Within-run | | | | |
| Range | 102.1-109.3 | 112.0-136.3 | 105.2-107.2 | 114.8-132.1 |
| Mean | 106.8 | 120.9 | 106.4 | 123.4 |
| Avd SD W-R | 0.63 | 0.86 | 0.70 | 1.11 |
| CV% W-R | 0.6% | 0.7% | 0.7% | 0.9% |
| Creatinine | | | | |
|-----------------------|-------------------|-------------------|---------------------|---------------------|
| All Users - All Sites | Normal<br>Syringe | Spiked<br>Syringe | Normal<br>Capillary | Spiked<br>Capillary |
| Whole Blood | | | | |
| N - Tests | 118 | 118 | 29 | 30 |
| N - Runs | 12 | 12 | 3 | 3 |
| N - Replicates | 10 | 10 | 10 | 10 |
| Within-run | | | | |
| Range | 0.43-0.69 | 1.47-1.70 | 0.5-0.55 | 1.42-1.52 |
| Mean | 0.6 | 1.57 | 0.52 | 1.45 |
| Avd SD W-R | 0.05 | 0.06 | 0.04 | 0.06 |
| CV% W-R | 7.6% | 3.9% | 6.8% | 3.9% |
. .
Figure 5.10 - Tables - Chloride and Creatinine Blood Precision Summaries
. .
:
{11}------------------------------------------------
## 5.6.3 Aqueous precision
Aqueous precision studies were performed at clinical sites to demonstrate precision when analyzed by end users. Samples tested were commercially available blood gas, electrolytes and metabolites control fluids, L1, L2 and L3 (Eurotrol, The Netherlands).
| User | QC Level | N | Mean | SD | %CV | Lot |
|---------------------------|----------|----|--------|------|------|-------------|
| Special Care Nursery RN 1 | L1 | 15 | 76.65 | 0.35 | 0.5% | 08-11243-00 |
| Special Care Nursery RN 2 | L1 | 15 | 76.69 | 0.35 | 0.5% | 08-11243-00 |
| Labor & Delivery RN 1 | L1 | 15 | 76.47 | 0.85 | 1.1% | 08-11244-00 |
| Labor & Delivery RN 2 | L1 | 15 | 76.60 | 0.40 | 0.5% | 08-11243-00 |
| Special Care Nursery RN 1 | L2 | 15 | 98.20 | 0.36 | 0.4% | 08-11250-00 |
| Special Care Nursery RN 2 | L2 | 15 | 98.47 | 0.30 | 0.3% | 08-11244-00 |
| Labor & Delivery RN 1 | L2 | 15 | 98.66 | 0.43 | 0.4% | 08-11243-00 |
| Labor & Delivery RN 2 | L2 | 15 | 98.17 | 0.50 | 0.5% | 08-11250-00 |
| Special Care Nursery RN 1 | L3 | 15 | 123.30 | 0.65 | 0.5% | 08-11250-00 |
| Special Care Nursery RN 2 | L3 | 15 | 123.29 | 0.26 | 0.2% | 08-11250-00 |
| Labor & Delivery RN 1 | L3 | 15 | 123.49 | 1.86 | 1.5% | 08-11250-00 |
| Labor & Delivery RN 2 | L3 | 15 | 123.70 | 0.52 | 0.4% | 08-11243-00 |
| User | QC Level | N | Mean | SD | %CV | Lot |
|-------------------------|----------|----|--------|------|------|-------------|
| NICU RN 1 | L1 | 15 | 76.26 | 0.71 | 0.9% | 08-11250-00 |
| Respiratory Therapist 1 | L1 | 15 | 76.71 | 0.30 | 0.4% | 08-11244-00 |
| Client Services Rep | L1 | 15 | 76.73 | 0.40 | 0.5% | 08-11243-00 |
| Anesthesia Tech 1 | L1 | 15 | 76.64 | 0.42 | 0.6% | 08-11243-00 |
| OP Surgery Tech 1 | L1 | 15 | 76.12 | 0.43 | 0.6% | 08-11250-00 |
| OP Surgery Tech 2 | L1 | 15 | 76.41 | 0.43 | 0.6% | 08-11250-00 |
| Phlebotomist 2 | L1 | 15 | 76.26 | 0.24 | 0.3% | 08-11243-00 |
| NICU RN 2 | L2 | 15 | 98.69 | 0.57 | 0.6% | 08-11250-00 |
| Respiratory Therapist 1 | L2 | 14 | 99.02 | 0.29 | 0.3% | 08-11244-00 |
| Client Services Rep | L2 | 15 | 98.96 | 0.65 | 0.7% | 08-11245-00 |
| Anesthesia Tech 1 | L2 | 14 | 99.10 | 0.18 | 0.2% | 08-11244-00 |
| Phlebotomist 1 | L2 | 15 | 98.18 | 0.30 | 0.3% | 08-11250-00 |
| OP Surgery Tech 1 | L2 | 15 | 98.38 | 0.74 | 0.8% | 08-11250-00 |
| OP Surgery Tech 2 | L2 | 15 | 98.45 | 0.48 | 0.5% | 08-11243-00 |
| NICU RN 3 | L3 | 15 | 125.39 | 0.89 | 0.7% | 08-11250-00 |
| Respiratory Therapist 1 | L3 | 15 | 124.52 | 0.37 | 0.3% | 08-11244-00 |
| Client Services Rep | L3 | 14 | 123.43 | 0.59 | 0.5% | 08-11250-00 |
| Anesthesia Tech 1 | L3 | 15 | 123.27 | 0.37 | 0.3% | 08-11243-00 |
| OP Surgery Tech 1 | L3 | 15 | 123.07 | 1.10 | 0.9% | 08-11250-00 |
| OP Surgery Tech 2 | L3 | 14 | 123.53 | 0.31 | 0.2% | 08-11243-00 |
Figure 5.11 - Table - Chloride Aqueous Precision Site 1
Figure 5.12 - Table - Chloride Aqueous Precision Site 2
{12}------------------------------------------------
| User | QC Level | N | Mean | SD | %CV | Lot |
|-------------------------|----------|----|------|------|------|-------------|
| Obstetrics RN 1 | L1 | 15 | 0.70 | 0.04 | 5.6% | 07-12130-00 |
| Phlebotomist 1 | L1 | 15 | 0.68 | 0.06 | 8.2% | 07-12129-00 |
| Respiratory Therapist 1 | L1 | 15 | 0.64 | 0.04 | 6.6% | 07-12136-00 |
| POC Technician | L1 | 15 | 0.66 | 0.05 | 7.2% | 07-12129-00 |
| Obstetrics RN 2 | L1 | 14 | 0.67 | 0.02 | 3.2% | 07-12129-00 |
| Phlebotomist 2 | L1 | 15 | 0.64 | 0.05 | 8.3% | 07-12132-00 |
| Medical Technologist | L1 | 15 | 0.68 | 0.04 | 5.3% | 07-12130-00 |
| Obstetrics RN 3 | L1 | 15 | 0.71 | 0.03 | 4.9% | 07-12129-00 |
| Obstetrics RN 1 | L2 | 15 | 2.18 | 0.09 | 4.2% | 07-12132-00 |
| Phlebotomist 1 | L2 | 15 | 1.91 | 0.07 | 3.5% | 07-12130-00 |
| Respiratory Therapist 1 | L2 | 15 | 2.03 | 0.05 | 2.3% | 07-12129-00 |
| POC Technician | L2 | 15 | 1.90 | 0.06 | 3.2% | 07-12130-00 |
| Obstetrics RN 2 | L2 | 15 | 2.12 | 0.11 | 5.0% | 07-12132-00 |
| Phlebotomist 2 | L2 | 15 | 2.06 | 0.09 | 4.2% | 07-12136-00 |
| Medical Technologist | L2 | 15 | 2.15 | 0.09 | 4.3% | 07-12136-00 |
| Obstetrics RN 3 | L2 | 15 | 1.98 | 0.06 | 3.2% | 07-12130-00 |
| Obstetrics RN 1 | L3 | 15 | 3.98 | 0.13 | 3.3% | 07-12129-00 |
| Phlebotomist 1 | L3 | 15 | 4.22 | 0.22 | 5.2% | 07-12132-00 |
| Respiratory Therapist 1 | L3 | 15 | 4.31 | 0.22 | 5.0% | 07-12130-00 |
| POC Technician | L3 | 15 | 4.44 | 0.18 | 4.1% | 07-12136-00 |
| Obstetrics RN 2 | L3 | 15 | 4.32 | 0.15 | 3.5% | 07-12129-00 |
| Phlebotomist 2 | L3 | 15 | 4.17 | 0.18 | 4.2% | 07-12129-00 |
| Medical Technologist | L3 | 15 | 4.58 | 0.25 | 5.4% | 07-12132-00 |
| Obstetrics RN 3 | L3 | 15 | 4.45 | 0.17 | 3.9% | 07-12132-00 |
Figure 5.13 – Table – Creatinine Aqueous Precision
and the comments of the country
:
.
· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·
{13}------------------------------------------------
| Chloride | | | |
|-------------------|------------|------------|------------|
| Control Fluids | QC Level 1 | QC Level 2 | QC Level 3 |
| Total Tests | | | |
| N - Tests | 165 | 163 | 148 |
| Mean | 76.5 | 98.6 | 123.7 |
| SD | 0.50 | 0.56 | 1.06 |
| CV% Total | 0.7% | 0.6% | 0.9% |
| Run-to-run | | | |
| N - Runs | 11 | 11 | 10 |
| Mean | 76.5 | 98.6 | 123.7 |
| SD | 0.21 | 0.34 | 0.71 |
| CV% R-R | 0.3% | 0.3% | 0.6% |
| Within-run | | | |
| N - WR Replicates | 15 | 15 | 15 |
| Avd SD W-R | 0.44 | 0.44 | 0.69 |
| CV% W-R | 0.6% | 0.4% | 0.6% |
| Creatinine | | | |
|-------------------|------------|------------|------------|
| Control Fluids | QC Level 1 | QC Level 2 | QC Level 3 |
| Total Tests | | | |
| N - Tests | 120 | 119 | 120 |
| Mean | 0.66 | 2.04 | 4.31 |
| SD | 0.05 | 0.13 | 0.27 |
| CV% Total | 6.8% | 6.4% | 6.3% |
| Run-to-run | | | |
| N - Runs | 8 | 8 | 8 |
| Mean | 0.66 | 2.04 | 4.31 |
| SD | 0.02 | 0.01 | 0.02 |
| CV% R-R | 3.4% | 5.5% | 4.0% |
| Within-run | | | |
| N - WR Replicates | 15 | 15 | 15 |
| Avd SD W-R | 0.04 | 0.08 | 0.21 |
| CV% W-R | 6.1% | 3.8% | 4.8% |
Figure 5.14 - Tables - Chloride and Creatinine Aqueous Precision Summaries
#### 5.6.4 Matrix Effects
The method comparison studies were performed in field trials at two 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.
| | Chloride epoc vs. i-STAT | | | |
|-----------|--------------------------|----------|-----------|------|
| | Venous | Arterial | Capillary | All |
| N | 49 | 43 | 63 | 155 |
| Sxx | 0.7 | 1.4 | 0.6 | 0.9 |
| Syy | 0.7 | 0.8 | 0.9 | 0.8 |
| slope | 1.00 | 0.96 | 1.02 | 0.99 |
| intercept | -0.24 | 2.35 | -3.06 | 0.20 |
| Syx | 2.5 | 1.9 | 1.3 | 1.9 |
| X min | 72 | 69 | 70 | 69 |
| X max | 136 | 136 | 139 | 139 |
| R² | 0.97 | 0.99 | 0.99 | 0.98 |
{14}------------------------------------------------
| | Creatinine epoc vs. Roche Cobas | | | |
|-----------|---------------------------------|----------|-----------|-------|
| | Venous | Arterial | Capillary | All |
| N | 53 | 42 | 49 | 144 |
| Sxx | 0.09 | 0.12 | 0.09 | 0.10 |
| Syy | 0.28 | 0.32 | 0.30 | 0.30 |
| slope | 1.03 | 1.04 | 1.01 | 1.03 |
| intercept | -0.12 | -0.11 | -0.06 | -0.10 |
| Syx | 0.47 | 0.48 | 0.40 | 0.45 |
| X min | 0.30 | 0.30 | 0.30 | 0.30 |
| X max | 14.50 | 14.30 | 14.80 | 14.80 |
| R2 | 0.99 | 0.99 | 0.99 | 0.99 |
Figure 5.15 – Table of Method Comparison Summary Against Predicate Device By Sample Matrix Type
| Chloride epoc vs. i-STAT, mM | | | |
|------------------------------|----------------|------|------|
| Matrix | Decision Level | 90 | 112 |
| Venous | Avg. Bias | 0.0 | 0.0 |
| | ±95% CI | 0.8 | 0.7 |
| Arterial | Avg. Bias | -0.9 | -1.7 |
| | ±95% CI | 0.8 | 0.4 |
| Capillary | Avg. Bias | -1.3 | -0.9 |
| | ±95% CI | 0.4 | 0.3 |
| All | Avg. Bias | -0.7 | -1.0 |
| | ±95% CI | 0.4 | 0.3 |
| Creatinine epoc vs. Roche Cobas, mg/dL | | | |
|----------------------------------------|----------------|-------|-------|
| Matrix | Decision Level | 1.25 | 1.60 |
| Venous | Avg. Bias | -0.08 | -0.07 |
| | ±95% CI | 0.05 | 0.05 |
| Arterial | Avg. Bias | -0.06 | -0.04 |
| | ±95% CI | 0.07 | 0.07 |
| Capillary | Avg. Bias | -0.05 | -0.04 |
| | ±95% CI | 0.03 | 0.03 |
| All | Avg. Bias | -0.06 | -0.05 |
| | ±95% CI | 0.03 | 0.03 |
Figure 5.16 - Table of Method Comparison Summary Against Predicate Device -Consolidated Bias by Sample Matrix Type :
{15}------------------------------------------------
### Effect of Anticoagulant 5.6.4.1
The effect of anticoagulant was evaluated on patient samples that were collected using heparinized and non-heparinized collection devices. This study was performed at a hospital (46 samples) and supplemented with in-house studies (29 samples). The data was analyzed using EP9-2A methodology.
| Chloride epoc Hep vs. No-Hep | Creatinine epoc Hep vs. No-Hep |
|------------------------------|--------------------------------|
| N | N |
| 76 | 77 |
| Sxx | Sxx |
| 0.6 | 0.26 |
| Syy | Syy |
| 0.8 | 0.33 |
| slope | slope |
| 0.98 | 0.99 |
| intercept | intercept |
| 1.92 | 0.02 |
| Syx | Syx |
| 1.2 | 0.23 |
| X min | X min |
| 99 | 0.42 |
| X max | X max |
| 129 | 10.53 |
| R2 | R2 |
| 0.97 | 0.99 |
Figure 5.17 – 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 substantially equivalent to the predicate devices.
{16}------------------------------------------------
# DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
EPOCAL Inc. c/o Roy Layer, Vice President, Quality Assurance & Regulatory Affairs 2060 Walkley Road Ottawa, Ontario, Canada K1G 3P5
Re: k113726
> Trade Name: epoc Chloride test, epoc Creatinine test Regulation Number: 21 CFR §862.1170 Regulation Name: Chloride test system Regulatory Class: Class II Product Codes: CGZ: CGL Dated: September 12, 2012 Received: September 13, 2012
OCT, 5 2012
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 (QS) regulation (21 CFR Part 820).
{17}------------------------------------------------
# Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you dosire specific as vior Diagnostic Devices and Radiological Health at (301) 796-5450. comact the Office of in Vitro Diaglious "Misbranding by reference to premarket notification" Also, prease note mo regarding postmarket surveillance, please contact CDRH'S (21 CF R Fur 001:37): 1 or questions : 05 St s) Division of Postmarket Surveillance at (301) Office of but vehiclibe and Drolling of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/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 Tou may ootain other general manational 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/ResourcesforYou/Industry/default.htm
Sincerely yours,
\$
Courtney H. Lias, Ph.D Director Division of Chemistry and Toxicology Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{18}------------------------------------------------
# Indications for Use
510(k): k113726
Device Name: epoc Chloride test
Indication For Use:
The Chloride 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.
Chloride measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of electrolyte and metabolic disorders.
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)
Yungs Chan
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k113726
{19}------------------------------------------------
# Indications for Use
510(k): k113726
Device Name: epoc Creatinine test
Indication For Use:
The Creatinine 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.
Creatinine measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of certain renal diseases and in monitoring renal dialysis.
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)
Yung Chan
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k113726
