← Product Code [JGS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGS) · K061597

# EPOC BLOOD ANALYSIS SYSTEM (K061597)

_Epocal, Inc. · JGS · Sep 27, 2006 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGS/K061597

## Device Facts

- **Applicant:** Epocal, Inc.
- **Product Code:** [JGS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGS.md)
- **Decision Date:** Sep 27, 2006
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1665
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Indications for Use

The EPOC Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of whole blood in the laboratory or at the point of care in hospitals, nursing homes or other clinical care institutions. The Blood Gas Electrolyte (BGE) test card panel configuration includes sensors for Sodium - Na, Potassium - K, ionized Calcium - iCa, pH, pCO2, pO2 and Hematocrit - Hct. Measurement of Sodium and Potassium are used in diagnosis and treatment diseases involving electrolyte imbalance. Measurement of Ionized Calcium is used in diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. Measurement of pH pCO2, pO2 (blood gases) is used in the diagnosis and treatment of life-threatening acid-base disturbances. Measurement Hct distinguish normal from abnormal states of blood volume, such as anemia and erythrocytosis.

## Device Story

System comprises single-use test card, card reader, and PDA host. Card contains sensor array (potentiometric, amperometric, conductimetric) and sealed calibrator reservoir. User introduces whole blood sample into card; reader heats card to 37°C, performs mechanical engagement to rupture calibrator, and digitizes raw sensor signals. Reader transmits data via Bluetooth to PDA host. Host software processes signals, calculates analytical values, and displays results. Used in clinical settings by trained professionals (nurses, RTs, assistants) for rapid point-of-care diagnostics. Output enables immediate clinical decision-making for critical care patients.

## Clinical Evidence

Clinical performance was evaluated via method comparison studies at hospital point-of-care sites (ICU, cardiac ICU, hematology/oncology, central lab). 142-156 patient samples (arterial, venous, mixed) were tested against the i-STAT predicate. Results showed high correlation (R=0.953-0.993) across all parameters (pH, pCO2, pO2, K, Na, iCa, Hct). Precision studies (20-day in-house and field trials with 7 operators) demonstrated acceptable CVs. Bench testing confirmed linearity (R2=0.998-0.999) and analytical specificity against various endogenous and exogenous interferences.

## Technological Characteristics

System uses electrochemical multi-sensor array (PVC ion-selective electrodes for pH, Na, K, iCa; Severinghaus-type for pCO2; membrane-coated gold cathode for pO2; conductivity for Hct). Reader includes thermal subsystem (37°C), Bluetooth connectivity, and PDA host. Operates on unit-use test cards with on-board calibrator. Software performs signal processing and calculation of analytical values.

## Regulatory Identification

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

## Predicate Devices

- i-Stat™ Model 300 Portable Clinical Analyzer ([K001387](/device/K001387.md))

## Submission Summary (Full Text)

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>
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY AND INSTRUMENT COMBINATION TEMPLATE

A. 510(k) Number:
k061597

B. Purpose for Submission:
New device

C. Measurand:
pH, pCO2, pO2, Na, K, iCa, Hct

D. Type of Test:
Electrode technology

E. Applicant:
Epocal, Inc.

F. Proprietary and Established Names:
Epoc Blood Analysis System

G. Regulatory Information:

1. Regulation section:
21 CFR§-862.1120-Blood gases (PCO2, PO2) and blood pH test system
21 CFR §-862.1665-Sodium test system
21 CFR§-862.1600-Potassium test system
21 CFR§-862.1145-Calcium test system
21 CFR§-864.6400-Hematocrit measuring device

2. Classification:
Class II

3. Product code:
CHL - Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood pH
JGS - Electrode, Ion Specific, Sodium
CEM - Electrode, Ion Specific, Potassium
JFP - Electrode, Ion Specific, Calcium
JPI - Device, Hematocrit Measuring

4. Panel:
Chemistry (75) Hematology (81)

H. Intended Use:

1. Intended use(s):
See indications for use below

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

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

Measurement of Sodium and Potassium are used in diagnosis and treatment diseases involving electrolyte imbalance. Measurement of Ionized Calcium is used in diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. Measurement of pH pCO2, pO2 (blood gases) is used in the diagnosis and treatment of life-threatening acid-base disturbances. Measurement Hct distinguish normal from abnormal states of blood volume, such as anemia and erythrocytosis.

3. Special conditions for use statement(s):
For prescription use

4. Special instrument requirements:
EPOC Card Reader, EPOC Host

I. Device Description:
The EPOC Blood Analysis System consists of three (3) components:

1. EPOC Test Card
The single use blood test card comprises a port for introduction of a blood sample to an array of sensors on a sensor module. The sensor module is mounted proximal to a fluidic channel contained in a credit-card sized housing. The card has an on-board calibrator contained in a sealed reservoir fluidically connected to the sensor array through a valve.

2. EPOC Card Reader
The reader is a minimally featured raw-signal acquisition peripheral. The reader comprises a card orifice for accepting a test card, and a mechanical actuation assembly for engaging the test card after it is inserted into the card orifice. Within the reader's card orifice there is a bar code scanner, an electrical contact array for contacting the card's sensor module, and a thermal subsystem for heating the card's measurement region to 37°C during the test. The reader also comprises circuits for amplifying, digitizing and converting the raw sensor signals to a wireless transmittable Bluetooth format,

3. EPOC Host
The host is a dedicated use Personal Digital Assistant (PDA) computing device

2

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with custom software that displays the test results. The reader and host computer together constitute all of the subsystems generally found in a traditional analyzer that operates on unit-use sensors and reagents.

## J. Substantial Equivalence Information:

1. Predicate device name(s): i-STAT Model 300
2. Predicate 510(k) number(s): k001387
3. Comparison with predicate:

|   | EPOC Blood Analysis System |   | i-STAT Model 300 |   | Same / Different  |
| --- | --- | --- | --- | --- | --- |
|  510(k) # | To be determined |   | K001387  |   |   |
|  Item | Device |   | Predicate  |   |   |
|  Intended use | The EPOC Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of whole blood using the BGE (Blood Gas Electrolyte) and ABG (Arterial Blood Gas) test card panels. |   | The i-STAT Model 300 Portable Clinical Analyzer is intended to be used by trained medical professionals for use with i-STAT test cartridges and MediSense blood glucose test strips. i-STAT cartridges comprise a variety of clinical chemistry tests and test panels. |   | same  |
|  Where used | hospital |   | Hospital |   | same  |
|  Measured parameters | pH, pCO2, pO2, Na, K, iCa, Hct |   | pH, pCO2, pO2, Na, K, iCa, Hct |   | same  |
|  Calculated parameters | TCO2, HCO3,BE,sO2,Hgb |   | TCO2, HCO3,BE,sO2,Hgb |   | same  |
|  Sample type | Venous, arterial whole blood |   | Venous, arterial and skin puncture whole blood |   | same  |
|  Reportable ranges | pH 6.5 - 8.0 | pH units | pH 6.5 - 8.2 | pH units | different  |
|   |  pCO2 5 - 250 | mm Hg | pCO2 5 - 130 | mm Hg | different  |
|   |  pO2 5 - 750 | mm Hg | pO2 5 - 800 | mm Hg | same  |
|   |  Na 85 - 180 | mmol/L | Na 100 - 180 | mmol/L | different  |
|   |  K 1.5 - 12 | mmol/L | K 2.0 - 9.0 | mmol/L | different  |
|   |  iCa 0.25 - 4 | mmol/L | iCa 0.25 - 2.5 | mmol/L | different  |
|   |  Hct 10 - 75 | %PCV | Hct 10 - 75 | %PCV | same  |
|   |  TCO2 1 - 85 | mmol/L | TCO2 5 - 50 | mmol/L | different  |
|   |  HCO3 1 - 85 | mmol/L | HCO3 1 - 85 | mmol/L | same  |
|   |  BE_{ecf} -30 - +30 | mmol/L | BE_{ecf} -30 - +30 | mmol/L | same  |
|   |  BE_{b} -30 - +30 | mmol/L | BE_{b} -30 - +30 | mmol/L | same  |
|   |  sO2 0 - 100 | % | sO2 0 - 100 | % | same  |
|   |  Hb 3.3 - 25 | g/dL | Hb 3 - 26 | g/dL | same  |
|  Sample volume | 95-125 μL |   | 100μL |   | same  |
|  Test card | Unit-use card with
- on-board calibrator in sealed reservoir
- an electrochemical multi-sensor array
- port for sample introduction
- fluid waste chamber |   | Unit-use cartridge with
- on-board calibrator in sealed reservoir
- an electrochemical multi-sensor array
- port for sample introduction
- fluid waste chamber |   | same  |
|  Test card storage | Room temperature until expiry date |   | Fridge storage until expiry date including max 2 weeks at room temperature |   | different  |
|  Sensor array | A laminated foil sensor module |   | A micro-fabricated chip-set |   | different  |
|  Tests/sensor components | pH - PVC ion selective electrode
pCO2 - QH modified Severinghaus type |   | pH - PVC ion selective electrode
pCO2 - QH modified Severinghaus type |   | same
same  |

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|   | pO2 - membrane coated gold cathode
Na - PVC ion selective electrode
K - PVC ion selective electrode
iCa - PVC ion selective electrode
Hct - conductivity, gold electrodes | pO2 - membrane coated gold cathode
Na - PVC ion selective electrode
K - PVC ion selective electrode
iCa - PVC ion selective electrode
Hct - conductivity, gold electrodes | same
same
same
same
same  |
| --- | --- | --- | --- |
|  Analyzer components | Two housings;
1 - The reader comprising
- Orifice for test card introduction
- electrical connector to card
- heater for 37°C operation
- mechanical card engagement device for
- making electrical contact to card's sensors
- for rupture of calibrator reservoir
- moving calibrator to sensors
- engaging heaters with card
- op-amp sensor signal detectors
- iQC monitoring devices
- Thermal controllers
- MUX
- A/D
- Bluetooth stack for wireless transmission of digitized raw sensor signals to computing device
- bar code scanner for acquiring card info
- internal electronic reader self-test circuit
2 - The computing device comprising a PDA
- microprocessor
- memory
- color LCD display
- keyboard
- i/o for communicating test results to other devices
- software to control the test and calculate analytical values from raw sensor signals
- battery operated with rechargeable batteries via plug in plug-in power supply | 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
- Thermal controllers
- MUX
- A/D
- wire transmission of digitized raw sensor signals to computing subsystem in same housing
- n/a
- internal and external electronic reader self-test circuit
- microprocessor
- memory
- monochrome LCD display
- keyboard
- i/o for communicating test results to other devices
- software to control the test and calculate analytical values from raw sensor signals
- battery operated with rechargeable batteries via external power supply in downloader cradle | different
same
same
same
same
same
same
same
same
same
different
different
different
same
different
different
same
same
different  |
|  Measurement temperature | 37°C | 37°C | same  |
|  Measurement time | Calibrate test card-introduce sample-measure | Introduce sample-calibrate test cartridge-measure | different  |
|  Error detection | iQC system to detect user errors
iQC system for reader self-check
iQC system to detect card non-conformance | iQC system to detect user errors
iQC system for reader self-check
iQC system to detect card non-conformance | same
same
same  |

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K. Standard/Guidance Document Referenced (if applicable):

|  Reference Number (Revision) | Title  |
| --- | --- |
|  CISPR 11:1997 + A1:1999 + A2:2002, modified | Limits and methods of measurement of electromagnetic disturbance characteristics of industrial, scientific and medical (ISM) radio-frequency equipment  |
|  CISPR 22:1997 + A1:2000 + A2:2002, modified | Information technology equipment. Radio disturbance characteristics. Limits and methods of measurement  |
|  IEC 60601-1: 1988 + A1:1991 + A2:1995 | Medical Electrical Equipment - Part 1-1: General Requirements for Safety - Collateral Standard: Safety Requirements for Medical Electrical Systems  |
|  IEC 60601-1-2:2001 | Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests  |
|  IEC 61000-3-2:2000, modified | Part 3-2: Limits for harmonic current emissions  |
|  IEC 61000-3-3:1994 (includes amendment A1:2001) | Part 3-3: Limits. Limitation of voltage fluctuations and flicker in low-voltage supply systems for equipment with rated current ≤16 A  |
|  IEC 61000-4-2:1995 + A1:1998 + A2:2000 | Part 4-2: Electrostatic discharge immunity test  |
|  IEC 61000-4-3:1995 + A1:1998 + A2:2000 | Part 4-3: Radiated, radio-frequency, electromagnetic field immunity test (Field strength 3 V/m. 80% AM modulated with 1kHz)  |
|  IEC 61000-4-4:1995 + A1:2000 + A2:2001 | Part 4-4: Electrical fast transient/burst immunity test  |
|  IEC 61000-4-5:1995 + A1:2000 | Part 4-5: Surge immunity test  |
|  IEC 61000-4-6:1996 + A1:2000 | Part 4-6: Immunity to conducted disturbances, induced by radio-frequency fields  |
|  IEC 61000-4-8:1993 + A1:2000 | Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test  |
|  IEC 61000-4-11:1994 +A1:2000 | Part 4-11: Voltage dips, short interruptions and voltage variations immunity tests  |
|  IEC 61010-1:2001 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General Requirements  |
|  IEC 61010-2-81:2001 | Part 2-081: Particular requirements for automatic and semi-automatic laboratory equipment for analysis and  |

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|  Reference Number (Revision) | Title  |
| --- | --- |
|   | other purposes  |
|  IEC 61010-2-101:2002 | Part 2:-101: Particular requirements for in vitro diagnostic (IVD) medical equipment  |
|  IEC 61326:2002 (includes amendments A1:1998, A2:2001 and A3:2003) | Electrical equipment for measurement, control and laboratory use - EMC Requirements  |
|  ISO 14971* (2000) | Medical devices - Application of risk management to medical devices  |
|  CLSI AST02-A (1999) | Point Of Care In Vitro Diagnostic IVD Testing; Approved Guideline  |
|  CLSI C46-A (2001) | Blood Gas and pH Analysis and Related Measurements; Approved Guideline  |
|  CLSI EP05-A (1999) | Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline  |
|  CLSI EP07-A (2002) | Interference Testing in Clinical Chemistry; Approved Guideline  |
|  CLSI EP09-A2 (2002) | Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second Edition  |
|  CLSI H07-A3 (2000) | Procedure for Determining Packed Cell Volume by the Microhematocrit Method - Second Edition; Approved Standard - Third Edition  |
|  CLSI H11-A4 (2004) | Procedures for the Collection of Arterial Blood Specimens; Approved Standard - Fourth Edition  |
|  SW68 (2001) | Medical device software - Software life cycle processes  |

# L. Test Principle:

There are three types of sensor measurements used in the EPOC BGE test card – potentiometric, amperometric and conductimetric.

In potentiometry, (for sodium, potassium, ionized calcium, pH and pCO2) the open circuit potential of a membrane coated sensor electrode (which is responsive to the concentration of the analyte) is measured versus a reference electrode (which is nonresponsive). The measurement is performed by a high input impedance operational amplifier in the card reader connected to each of the electrode pairs comprising sensor electrode and reference electrode.

In amperometry (for pO2) the current, i, flowing through a membrane-coated amperometric indicator electrode to the ground electrode is measured, when the indicator electrode is poised at a fixed potential versus the reference electrode.

Hematocrit is measured by ac conductimetry. A pair of spaced apart electrodes in the flow channel is used to minimize contact impedance and blood cell settling errors. The down-stream conductivity-high electrode also serves as the detector for adequate sample volume delivery. The measurement employs a  $20\mathrm{kHz}$  voltage source with

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100mV p-p. The normalized sensor signal is the ratio of the resistance of blood to the resistance of calibrator fluid.

## M. Performance Characteristics (if/when applicable):

### 1. Analytical performance:

#### a. Precision/Reproducibility:

Commercial Quality Control Material

This study used the CLSI guideline for a twenty day precision study with one run per day. (CLSI EP5-A “Evaluation of Precision Performance of Clinical Chemistry Devices”). Cards from four lots from the pilot production process were randomized. Two cards per day at each control level over a twenty day span. Mission Control Aqueous Blood gas Controls levels 1 and 3 were used for all analytes and Mission Control Hematocrit Controls levels A and B for hematocrit only.

|   | L1  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|   | pH | pCO2 | pO2 | Na+ | K+ | Ca++ | Hct  |
|  Mean | 6.986 | 80.6 | 78.4 | 114.5 | 2.15 | 2.2 | -16.9  |
|  SWR | 0.006 | 1.94 | 1.94 | 0.57 | 0.021 | 0.023 | 0.35  |
|  %CVWR | 0.09% | 2.40% | 2.47% | 0.50% | 0.97% | 1.02% |   |
|  SDD | 0.004 | 1.31 | 1.96 | 0.67 | 0.011 | 0.017 | 0.42  |
|  %CVDD | 0.05% | 1.63% | 2.50% | 0.59% | 0.51% | 0.76% |   |
|  ST | 0.008 | 2.36 | 2.57 | 0.80 | 0.025 | 0.028 | 0.49  |
|  %CVT | 0.11% | 2.92% | 3.28% | 0.70% | 1.15% | 1.26% |   |
|   | L3  |   |   |   |   |   |   |
|   | pH | pCO2 | pO2 | Na+ | K+ | Ca++ | Hct  |
|  Mean | 7.676 | 22.5 | 141.2 | 153.2 | 6.58 | 0.67 | -14.5  |
|  SWR | 0.005 | 0.36 | 1.78 | 0.71 | 0.053 | 0.009 | 0.36  |
|  %CVWR | 0.06% | 1.61% | 1.26% | 0.47% | 0.80% | 1.29% |   |
|  SDD | 0.004 | 0.55 | 1.44 | 0.77 | 0.037 | 0.010 | 0.33  |
|  %CVDD | 0.05% | 2.44% | 1.02% | 0.50% | 0.56% | 1.43% |   |
|  ST | 0.006 | 0.56 | 2.24 | 0.97 | 0.064 | 0.012 | 0.46  |
|  %CVT | 0.08% | 2.50% | 1.58% | 0.63% | 0.98% | 1.77% |   |
|   | Level A | Level B  |
| --- | --- | --- |
|   | Hct | Hct  |
|  Mean | 25.3 | 46.1  |
|  SWR | 0.370 | 0.68  |
|  %CVT | 1.46% | 1.48%  |
|  SDD | 0.160 | 0.00  |
|  %CVT | 0.63% | 0.00%  |

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|   | Level A | Level B  |
| --- | --- | --- |
|  ST | 0.400 | 0.68  |
|  %CVT | 1.58% | 1.48%  |

# Whole blood

Whole blood test materials were prepared from fresh blood drawn into a green top heparinized vacuum collection tube from a Company volunteer in the morning on each test day. The normal blood sample (nb), as collected, comprised the first test material. A spiked blood sample (sb) was tonometered and electrolyte spiked to an elevated analyte level for the second test material.

|   | nb |   |   |   |   |   |   | sb  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Lot | pH | pCO2 | pO2 | Na+ | K+ | Ca++ | Hct | pH | pCO2 | pO2 | Na+ | K+ | Ca++ | Hct  |
|  06024-1 | 0.006 | 1.54 | 1.75 | 0.61 | 0.02 | 0.021 | 0.70 | 0.009 | 3.30 | 2.47 | 1.93 | 0.07 | 0.022 | 0.99  |
|  06025-1 | 0.008 | 1.49 | 2.71 | 0.72 | 0.04 | 0.014 | 0.69 | 0.014 | 1.79 | 2.29 | 1.08 | 0.04 | 0.027 | 0.43  |
|  06026-1 | 0.005 | 1.05 | 1.85 | 0.90 | 0.02 | 0.016 | 0.97 | 0.006 | 3.77 | 1.72 | 1.01 | 0.03 | 0.025 | 0.54  |
|  06027-1 | 0.006 | 1.27 | 2.07 | 0.83 | 0.03 | 0.014 | 0.91 | 0.011 | 3.91 | 1.64 | 1.22 | 0.05 | 0.029 | 0.46  |
|  06031-1 | 0.009 | 2.02 | 0.92 | 0.87 | 0.06 | 0.017 | 0.61 | 0.012 | 4.12 | 2.15 | 1.88 | 0.06 | 0.038 | 0.71  |
|  06032-1 | 0.010 | 1.13 | 1.60 | 1.46 | 0.06 | 0.019 | 0.96 | 0.009 | 2.24 | 2.00 | 1.49 | 0.07 | 0.027 | 1.24  |
|  06033-1 | 0.004 | 0.79 | 3.85 | 1.90 | 0.07 | 0.034 | 0.89 | 0.009 | 3.48 | 3.68 | 2.36 | 0.10 | 0.047 | 0.96  |
|  06034-1 | 0.009 | 1.32 | 3.73 | 1.41 | 0.10 | 0.023 | 0.98 | 0.009 | 2.75 | 5.76 | 1.89 | 0.08 | 0.040 | 0.85  |
|  06038-1 | 0.008 | 1.25 | 4.65 | 1.56 | 0.07 | 0.021 | 0.64 | 0.009 | 3.36 | 5.57 | 1.64 | 0.08 | 0.035 | 0.83  |
|  06040-1 | 0.007 | 1.75 | 1.59 | 0.44 | 0.03 | 0.016 | 0.42 | 0.009 | 2.23 | 1.47 | 0.61 | 0.03 | 0.018 | 0.33  |
|  06041-1c | 0.006 | 0.87 | 3.02 | 1.02 | 0.02 | 0.020 | 0.83 | 0.009 | 3.24 | 1.66 | 1.47 | 0.04 | 0.035 | 0.77  |
|  06041-1s | 0.008 | 0.82 | 3.13 | 0.90 | 0.02 | 0.023 | 0.66 | 0.009 | 2.50 | 1.72 | 1.55 | 0.05 | 0.025 | 0.67  |
|  06045-1 | 0.005 | 1.57 | 1.13 | 0.68 | 0.04 | 0.019 | 0.73 | 0.010 | 2.71 | 2.17 | 1.83 | 0.04 | 0.028 | 0.87  |
|  06046-1 | 0.005 | 1.93 | 2.08 | 0.48 | 0.03 | 0.012 | 0.55 | 0.008 | 1.99 | 1.56 | 0.81 | 0.02 | 0.009 | 0.76  |
|  06047-1 | 0.005 | 1.18 | 1.69 | 0.41 | 0.03 | 0.016 | 0.62 | 0.004 | 2.66 | 1.05 | 1.36 | 0.03 | 0.017 | 0.50  |
|  06048-1 | 0.007 | 2.14 | 1.82 | 0.84 | 0.02 | 0.017 | 0.50 | 0.008 | 2.57 | 2.99 | 0.88 | 0.03 | 0.025 | 0.32  |
|  06052-1 | 0.009 | 1.74 | 2.54 | 1.07 | 0.04 | 0.017 | 0.42 | 0.008 | 3.12 | 1.99 | 1.57 | 0.06 | 0.012 | 0.52  |
|  06053-1 | 0.007 | 1.27 | 1.66 | 0.45 | 0.04 | 0.014 | 0.51 | 0.007 | 2.19 | 1.98 | 1.25 | 0.03 | 0.019 | 0.55  |
|  06054-1 | 0.007 | 2.04 | 1.53 | 0.97 | 0.02 | 0.010 | 1.07 | 0.005 | 2.63 | 2.65 | 1.39 | 0.03 | 0.021 | 0.49  |
|  06055-1 | 0.006 | 2.17 | 1.38 | 1.41 | 0.05 | 0.023 | 0.60 | 0.013 | 3.31 | 2.04 | 0.82 | 0.04 | 0.015 | 0.48  |
|  Mean | 7.200 | 65.0 | 38.0 | 147 | 4.30 | 1.35 | 44.0 | 7.700 | 90.0 | 70.0 | 168.0 | 6.20 | 2.20 | 22.0  |
|  X+ | 0.0068 | 1.47 | 2.24 | 0.95 | 0.041 | 0.018 | 0.71 | 0.0089 | 2.89 | 2.43 | 1.40 | 0.050 | 0.026 | 0.66  |
|  CV % | 0.09% | 2.26% | 5.88% | 0.64% | 0.96% | 1.35% | 1.62% | 0.12% | 3.21% | 3.47% | 0.83% | 0.80% | 1.17% | 3.02%  |

The data indicates that the whole blood imprecision data are consistent with the aqueous imprecision data.

Supplemental field trial data acquired at one hospital at three different POC sites: the cardiac ICU, the medical ICU and the Neonatal ICU. From these sites various operators who perform POC testing on the predicate device were chosen for inclusion in the study. The study included 2 nurses, 2 RT's and 3 nurses' assistants.

The following protocol was used. After a training period each POC operator was asked to run 10 replicates of a whole blood patient sample. A different sample was used for each precision study. There were 5 readers in operation for each precision study, 2 test replicates being run per each of 5 readers for a total of 10 replicates.

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|   |  |  | pH | PCO2 | PO2 | Na | K | Ca | Hct  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Site 1 | Operator 1 |  |  |  |  |  |  |  |   |
|   |  | mean: | 7.365 | 52.3 | 28.6 | 142.3 | 4.04 | 1.20 | 40.1  |
|   |  | sd: | 0.006 | 1.98 | 1.71 | 0.48 | 0.05 | 0.018 | 0.57  |
|   |  | cv%: | 0.08 | 3.8 | 6.0 | 0.3 | 1.3 | 1.5 | 1.4  |
|   |  | n: | 10 | 10 | 10 | 10 | 10 | 10 | 10  |
|  Site 1 | Operator 2 |  |  |  |  |  |  |  |   |
|   |  | mean: | 7.368 | 49.2 | 31.3 | 140.0 | 4.0 | 1.19 | 40  |
|   |  | sd: | 0.005 | 0.94 | 1.83 | 1.49 | 0.00 | 0.023 | 0.52  |
|   |  | cv%: | 0.06 | 1.9 | 5.5 | 1.0 | 0.0 | 1.9 | 1.3  |
|   |  | n: | 10 | 10 | 10 | 10 | 10 | 10 | 10  |
|  Site 2 | Operator 3 |  |  |  |  |  |  |  |   |
|   |  | mean: | 7.322 | 56.9 | 33.9 | 141.9 | 3.70 | 1.191 | 39.2  |
|   |  | sd: | 0.005 | 0.87 | 1.20 | 1.20 | 0.00 | 0.020 | 0.63  |
|   |  | cv%: | 0.04 | 1.5 | 3.5 | 0.8 | 0.0 | 1.7 | 1.6  |
|   |  | n: | 10 | 10 | 10 | 10 | 10 | 10 | 10  |
|  Site 2 | Operator 4 |  |  |  |  |  |  |  |   |
|   |  | mean: | 7.335 | 55.4 | 30.0 | 143.0 | 3.81 | 1.211 | 40.7  |
|   |  | sd: | 0.006 | 1.36 | 1.49 | 0.82 | 0.03 | 0.026 | 0.48  |
|   |  | cv%: | 0.08 | 2.5 | 5.0 | 0.6 | 0.8 | 2.1 | 1.2  |
|   |  | n: | 10 | 10 | 10 | 10 | 10 | 10 | 10  |
|  Site 2 | Operator 5 |  |  |  |  |  |  |  |   |
|   |  | mean: | 7.303 | 58.9 | 40.1 | 142.9 | 3.69 | 1.20 | 39.9  |
|   |  | sd: | 0.009 | 1.11 | 1.23 | 0.74 | 0.03 | 0.019 | 0.57  |
|   |  | cv%: | 0.12 | 1.9 | 3.1 | 0.5 | 0.9 | 1.6 | 1.4  |
|   |  | N: | 10 | 10 | 10 | 10 | 10 | 10 | 10  |
|  Site 3 | Operator 6 |  |  |  |  |  |  |  |   |
|   |  | mean: | 7.266 | 61.7 | 61.8 | 140.6 | 359 | 1.226 | 39.8  |
|   |  | sd: | 0.006 | 1.80 | 3.47 | 0.84 | 0.03 | 0.022 | 0.79  |
|   |  | cv%: | 0.08 | 2.9 | 5.6 | 0.6 | 0.9 | 1.8 | 2.0  |
|   |  | n: | 10 | 10 | 10 | 10 | 10 | 10 | 10  |
|  Site 3 | Operator 7 |  |  |  |  |  |  |  |   |
|   |  | mean: | 7.381 | 41.5 | 74.6 | 139.5 | 4.14 | 1.236 | 37.5  |
|   |  | sd: | 0.004 | 0.87 | 2.91 | 0.97 | 0.05 | 0.024 | 0.71  |
|   |  | cv%: | 0.05 | 2.1 | 3.9 | 0.7 | 1.2 | 1.9 | 1.9  |
|   |  | n: | 10 | 10 | 10 | 10 | 10 | 10 | 10  |

# b. Linearity/assay reportable range:

The summary statistics for the whole blood linearity data set are tabulated as follows:

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

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Calibration of the EPOC system is performed using both primary and secondary NIST traceable standards.

For calibration of blood gases multiple blood samples are obtained. These are prepared by tonometry to various analytical levels spanning the reportable range. To establish proper calibration for gases, the analytical values from the EPOC system are compared with both the tonometry value (using gas compositions traceable to NIST standards) and the value obtained from two commercially available blood gas and electrolyte instruments in routine use in the clinical laboratory. Each instrument itself is calibrated with NIST traceable gas mixtures.

d. Detection limit:

The detection limit is defined as the lower limit of the linearity.

e. Analytical specificity:

Interference testing was performed to demonstrate the specificity of the EPOC measurements.

The following protocol was used. A normal whole blood sample (collected into a heparinized green top vacuum collection tube) was divided into two equal volume aliquots, each aliquot then spun down. A spiking solution of the test interference was prepared in aqueous solution and added into the plasma of the first aliquot, at  $25\mu \mathrm{L}$  of spiking solution per mL of plasma. The second plasma aliquot was spiked with the aqueous spiking solution containing no test interference (blank control), also at  $25\mu \mathrm{L}$  per mL of plasma. The concentration of the test interference in the spiking solution was calculated to achieve the desired test level when diluted into the plasma. After spiking, the plasma and blood cells were reconstituted. In some cases where the test interference was only sparingly soluble in aqueous solution or where it was slow to fully dissolve, ethanol spike solutions instead of aqueous were used. Interference test levels were those recommended by the CLSI guideline (CLSI EP7-A).

The applicant measured the spiked blood and the blank on the EPOC system, each plasma sample measured six times, as well as on an in-house reference

{10}

instrument. In most cases six replicates was sufficient to resolve the bias. Where resolution was insufficient replicates were added. Two EPOC readers were used. In the first round the applicant measured A (the test blood) on reader 1 and B (the blank) on reader 2 at the same time, and A then B on the reference instrument also at the same time. In the second round the applicant measured B on reader 1 and A on reader 2 and B then A on the reference instrument, all at the same time. Six rounds in total were performed, reversing the AB order in each round. The applicant computed the bias between test and blank as the mean of each AB difference from the six rounds. If the AB difference was systematically changing from round to round (because the analyte value was changing over time differently in the test blood and the control, the applicant computed the difference between the EPOC AB pairs and the AB pairs from the reference instrument for each round.

In most cases the interference could be established directly from the test minus control result. In some cases where the addition caused changes in both test and control that were in addition to interference effects, or where the samples where unstable over time, the applicant computed the test minus control versus the test minus control for a reference instrument known not to have an interference, then compared the result against the reference instrument result as the control and used that value.

The table below shows the random error, RE, of each method, expressed either as a standard deviation or a coefficient of variation (CV%). SDdiff = 1.4RE is the standard deviation of the difference between a pair of measurements. The 95% confidence limit of the mean difference of 6 replicates is given by $2SD_{diff} / \sqrt{6}$. This is the value of measured bias due to interference, b, which can be resolved as being different from zero with 95% confidence. b/TE is the resolvable bias expressed as a fraction of the total allowable error. SEc = TE - 1.65RE is the critical systematic error which results in a medically significant error more than 5% of the time. SEc/TE is the critical systematic error expressed as a fraction of the total allowable error.

|   | pH | pCO2 | pO2 | K | Na | iCa | Hct  |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  TE | 0.04 | 8% | 10% | 0.5 | 4 | 5% | 2.0% PCV  |
|  RE | 0.007 | 2.2% | 3.5% | 0.04 | 0.95 | 1.35% | 0.7% PCV  |
|  SDdiff | 0.01 | 3.9% | 4.9% | 0.06 | 1.3 | 2.1% | 1.0% PCV  |
|  95% confidence | 0.008 | 3.1% | 3.9% | 0.05 | 1.1 | 1.7% | 0.8% PCV  |
|  b/TE | 0.2 | 0.4 | 0.39 | 0.1 | 0.27 | 0.34 | 0.4  |
|  Sec | 0.023 | 3.3% | 5.0% | 0.43 | 2.43 | 2.5% | 0.85% PCV  |
|  SEc/TE | 0.6 | 0.41 | 0.48 | 0.87 | 0.61 | 0.5 | 0.42  |

The interference test data are shown in tabulated form below. For each tested interference there is an entry showing the concentration of test interference and the result of the mean difference between the blood with interference and

{11}

the blank blood, expressed in multiples of the total allowable error (except where the interference is entered at  $\%$  , in which case the value is percent bias).

|  Exogenous Interference | Level | Mean(Test result - blank control)/TE  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |  | pH | pCO2 | pO2 | K | Na | iCa | Hct  |
|  Ethanol | 447 mg/dL | -0.4 | -0.2 | 0.0 | +0.1 | +0.1 | 0.0 | +0.3  |
|  Sodium pentothal | 1 mmol/L | 0.0 | +0.1 | -0.2 | +0.1 | +0.2 | -0.4 | +0.1  |
|  Acetyl salicylate | 4.3 mmol/L | 0.0 | -0.1 | -0.1 | 0.0 | 0.0 | -0.4 | +0.2  |
|  Ascorbate | 0.4 mmol/L | +0.1 | -0.3 | +0.2 | 0.0 | 0.0 | 0.0 | +0.1  |
|  Salycilate | 4.3 mmol/L | +0.3 | 0.0 | -0.2 | +0.1 | 0.0 | -0.4 | -0.1  |
|  Bromide | 18 mmol/L | -0.6 | +7% | +0.3 | +0.1 | +0.3 | +0.3 | -0.3  |
|  Bromide | 37.5 mmol/L | -1.2 | +13% | +0.0 | +0.2 | +0.6 | +0.9 | X  |
|  Iodide | 1 mmol/L | -0.5 | 5% | -0.1 | +0.0 | +0.1 | +0.3 | -0.1  |
|  Iodide | 3 mmol/L | -1.2 | 11% | -0.2 | +0.2 | +0.0 | +0.3 | X  |
|  Ibuprofen | 2.2 mmol/L | -0.3 | +0.1 | -0.1 | 0.0 | -0.1 | -0.3 | +0.1  |
|  Tylenol | 1.66 mmol/L | 0.0 | -0.1 | 0.0 | 0.0 | 0.0 | 0.0 | X  |
|  Ammonium | 2 mmol/L | +0.1 | -0.2 | -0.1 | 0.0 | 0.0 | -0.1 | X  |
|  Lithium | 4 mmol/L | -0.1 | -0.1 | 0.0 | +0.1 | 0.0 | +0.1 | -0.1  |
|  Halothane | 2.7% | X | X | 0.0 | X | X | X | X  |
|  Endogenous interference | Level | Mean(Test result - blank control)/TE  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |  | pH | pCO2 | pO2 | K | Na | iCa | Hct  |
|  NaCl | 20 mmol/L | -0.3 | +0.1 | -0.1 | +0.1 | X | +0.1 | X  |
|  KCl | 8 mmol/L | +0.2 | 0.0 | 0.0 | X | +0.1 | -0.4 | X  |
|  CaCl2 | 3 mmol/L | +0.1 | +0.3 | -0.3 | +0.1 | +0.4 | X | X  |
|  pH | +/-0.4 pH | X | X | 0.0 | 0.0 | +0.1 | -/+0.3 | X  |
|  pCO2 | -/+60 mm Hg |  |  |  |  |  |  |   |
|  Bicarbonate | 20 mmol/L | +0.5 | +0.3 | -0.3 | 0.1 | +0.1 | +0.1 | X  |
|  Lactate | 10 mmol/L | +0.2 | +0.1 | +0.0 | -0.1 | -0.3 | -0.3 | X  |
|  Hct | +20% PCV |  | -0.1 | +0.1 | 0.0 | -0.5 | -0.5 | X  |
|  Total Protein | +3 g/dL | -0.1 | -0.1 | +0.1 | -0.1 | -0.5 | -0.5 | +0.8  |
|  Lipids | 0.8% | +0.0 | +0.2 | +0.1 | +0.1 | +0.0 | +0.2 | +0.1  |
|  Cholesterol | 9.1 mmol/L | 0.0 | +0.1 | 0.0 | 0.0 | 0.0 | 0.0 | +0.3  |
|  Hydroxy butyrate | 20 mmol/L | +0.4 | -0.2 | +0.1 | -0.1 | -0.7 | -0.6 | -0.7  |
|  Cysteine | 1 mmol/L | -0.2 | +0.2 | 0.0 | 0.0 | 0.0 | 0.0 | -0.1  |
|  Bilirubin | 0.26 mmol/L | +0.1 | +0.2 | -0.1 | 0.0 | +0.1 | -0.2 | +0.1  |
|  NH4 | 2 mmol/L | -0.3 | -0.3 | +0.5 | -0.1 | 0.0 | -0.1 | -0.1  |
|  Phosphate | 2 mmol/L | X | X | X | -0.1 | 0.0 | -0.5 | -0.3  |

f. Assay cut-off: Not Applicable

2. Comparison studies:

a. Method comparison with predicate device:

Method comparison to the predicate device was conducted with patient samples where possible. In the laboratory phase of the clinical trial at the hospital site, additional data were collected on patient samples spiked with sodium and calcium. Spiked samples were used for range testing of the EPOC device to validate that the EPOC sensors were operating to specification across a larger data range than is usually encountered in clinical trials for

{12}

sodium and calcium These analytes, in particular sodium, exhibit a narrow range in patient samples, even in large studies with over 100 patient samples. To obtain  $R > 0.9$  in method comparison studies the patient data were supplemented with spiked samples. Additionally some method comparison data on samples with potassium and pH spikes were added. Samples for range-testing were whole blood specimens collected in green top vacuum collection tubes with normal range values for these analytes, which were then adjusted to elevated calcium, sodium and potassium values by spiking with the chloride salts of those ions, and elevated pH by spiking with NaOH.

|  Sodium | Patient samples only | Patient samples and spikes  |
| --- | --- | --- |
|  N | 142 | 156  |
|  Sxx | 0.61 | 0.62  |
|  Syy | 0.80 | 0.88  |
|  a | 8.835 | -9.579  |
|  b | 0.941 | 1.077  |
|  Syx | 2.05 | 2.22  |
|  X min | 123 | 123  |
|  X max | 146 | 179  |
|  R | 0.880 | 0.953  |

![img-0.jpeg](img-0.jpeg)

|  Ionized Calcium | Patient samples only | Patient samples and spikes  |
| --- | --- | --- |
|  N | 143 | 156  |
|  Sxx | 0.016 | 0.016  |
|  Syy | 0.014 | 0.015  |
|  a | 0.102 | -0.026  |
|  b | 0.908 | 1.021  |
|  Syx | 0.029 | 0.031  |
|  X min | 0.80 | 0.80  |
|  X max | 1.59 | 2.20  |
|  R | 0.943 | 0.985  |

![img-1.jpeg](img-1.jpeg)

{13}

|  Potassium | Patient samples only | Patient samples and spikes  |
| --- | --- | --- |
|  N | 142 | 146  |
|  Sxx | 0.047 | 0.048  |
|  Syy | 0.046 | 0.049  |
|  a | -0.044 | -0.018  |
|  b | 1.021 | 1.013  |
|  Syx | 0.094 | 0.094  |
|  X min | 2.5 | 2.5  |
|  X max | 6.7 | 7.8  |
|  R | 0.989 | 0.993  |

![img-2.jpeg](img-2.jpeg)

|  pH | Patient samples only | Patient samples and spikes  |
| --- | --- | --- |
|  N | 142 | 149  |
|  Sxx | 0.013 | 0.014  |
|  Syy | 0.006 | 0.007  |
|  a | 0.029 | 0.251  |
|  b | 0.995 | 0.9651  |
|  Syx | 0.018 | 0.020  |
|  X min | 6.991 | 6.770  |
|  X max | 7.592 | 7.982  |
|  R | 0.987 | 0.991  |

![img-3.jpeg](img-3.jpeg)

|  pCO2 | Patient samples only | see Linearity for Range verification  |
| --- | --- | --- |
|  N | 143 |   |
|  Sxx | 1.5 |   |
|  Syy | 1.1 |   |
|  a | -0.9 |   |
|  b | 1.041 |   |
|  Syx | 2.4 |   |
|  X min | 19.7 |   |
|  X max | 112.2 |   |
|  R | 0.990 |   |

![img-4.jpeg](img-4.jpeg)

{14}

|  pO2 Patient samples |   |
| --- | --- |
|  N 142 Sxx 4.6 Syy 2.7 a -1.7 b 1.053 Syx 6.6 X min 26.0 Xmax 226.5 R 0.978 |   |
|  Hct Patient samples |   |
| --- | --- |
|  N 142 Sxx 0.58 Syy 0.64 a -1.1 b 1.066 Syx 1.36 X min 19 X max 73 R 0.987 |   |
|  Hct Patient samples |   |
| --- | --- |
|  N 80 70 60 50 40 30 20 10 0 | 10 20 30 40 50 60 70 80 REF Xm  |

# b. Matrix comparison:

Matrix comparison testing was performed. The results are organized by analyte and by sample type (heparinized whole blood samples versus non-heparinized whole blood).

|   | Heparinized | Non-heparinized | All  |
| --- | --- | --- | --- |
|  pH |  |  |   |
|  N | 93 | 49 | 142  |
|  Sxx | 0.013 | 0.013 | 0.013  |
|  Syy | 0.006 | 0.007 | 0.006  |
|  a | 0.171 | -0.320 | 0.029  |
|  b | 0.975 | 1.043 | 0.995  |
|  Syx | 0.017 | 0.019 | 0.018  |
|  X min | 6.991 | 7.174 | 6.991  |
|  X max | 7.592 | 7.557 | 7.592  |

{15}

|   | Heparinized | Non-heparinized | All  |
| --- | --- | --- | --- |
|  R | 0.989 | 0.977 | 0.987  |
|  pCO2 |   |   |   |
|  N | 93 | 50 | 143  |
|  Sxx | 1.4 | 1.6 | 1.5  |
|  Syy | 1.1 | 1.1 | 1.1  |
|  a | -1.3 | 2.3 | -0.9  |
|  b | 1.051 | 0.962 | 1.041  |
|  Syx | 2.4 | 2.4 | 2.4  |
|  X min | 19.7 | 23.6 | 19.7  |
|  X max | 112.2 | 63.0 | 112.2  |
|  R | 0.992 | 0.967 | 0.990  |
|  pO2 |   |   |   |
|  N | 92 | 50 | 142  |
|  Sxx | 3.3 | 6.3 | 4.6  |
|  Syy | 2.7 | 2.7 | 2.7  |
|  a | -1.7 | -1.7 | -1.7  |
|  b | 1.050 | 1.063 | 1.053  |
|  Syx | 7.5 | 4.6 | 6.6  |
|  X min | 26.0 | 35.5 | 26.0  |
|  X max | 226.5 | 187.5 | 226.5  |
|  R | 0.978 | 0.992 | 0.978  |
|  K |   |   |   |
|  N | 93 | 49 | 142  |
|  Sxx | 0.046 | 0.049 | 0.047  |
|  Syy | 0.046 | 0.045 | 0.046  |
|  a | -0.144 | 0.100 | -0.044  |
|  b | 1.046 | 0.987 | 1.021  |
|  Syx | 0.085 | 0.105 | 0.094  |
|  X min | 2.5 | 2.9 | 2.5  |
|  X max | 6.1 | 6.7 | 6.7  |
|  R | 0.989 | 0.989 | 0.989  |
|  Na |   |   |   |
|  N | 93 | 49 | 142  |
|  Sxx | 0.64 | 0.55 | 0.61  |
|  Syy | 0.81 | 0.80 | 0.80  |
|  a | 13.7 | 26.5 | 8.8  |
|  b | 0.902 | 0.821 | 0.941  |
|  Syx | 1.96 | 1.90 | 2.05  |
|  X min | 123 | 130 | 123  |
|  X max | 145 | 146 | 146  |
|  R | 0.876 | 0.837 | 0.880  |
|  iCa |   |   |   |
|  N | 93 | 50 | 143  |
|  Sxx | 0.016 | 0.015 | 0.016  |
|  Syy | 0.014 | 0.015 | 0.014  |
|  a | 0.034 | 0.111 | 0.102  |

{16}

|   | Heparinized | Non-heparinized | All  |
| --- | --- | --- | --- |
|  b | 0.958 | 0.918 | 0.908  |
|  Syx | 0.026 | 0.020 | 0.029  |
|  X min | 0.8 | 1.0 | 0.8  |
|  X max | 1.6 | 1.3 | 1.6  |
|  R | 0.960 | 0.962 | 0.943  |
|  Hct |   |   |   |
|  N | 92 | 50 | 142  |
|  Sxx | 0.53 | 0.68 | 0.58  |
|  Syy | 0.61 | 0.68 | 0.64  |
|  a | -0.989 | -0.512 | -1.1  |
|  b | 1.067 | 1.041 | 1.066  |
|  Syx | 1.18 | 1.64 | 1.36  |
|  X min | 19 | 23 | 19  |
|  X max | 73 | 60 | 73  |
|  R | 0.991 | 0.968 | 0.987  |

3. Clinical studies:

a. Clinical Sensitivity: Not Applicable
b. Clinical specificity: Not Applicable
c. Other clinical supportive data (when a. and b. are not applicable): Not Applicable

4. Clinical cut-off: Not Applicable

5. Expected values/Reference range: Literature references are provided in the labeling.

N. Instrument Name:

EPOC Blood Analysis System

O. System Descriptions:

1. Modes of Operation:

Single sample mode of operation for sample reader, Host Personal Digital Assistant (PDA) can link to up to seven readers and actively control up to 4 readers in the analysis mode.

{17}

18

2. Software:

FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:

Yes ☑ or No ☐

3. Specimen Identification:

Hand entry or Bar-Code

4. Specimen Sampling and Handling:

Single sample using syringe

5. Calibration:

Unitized calibrator fluid

6. Quality Control:

Internal Quality control and recommendation of commercially available external quality control material

P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above:

Q. Proposed Labeling:

The labeling is sufficient and satisfies the requirements of 21 CFR Part 809.10.

R. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGS/K061597](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGS/K061597)

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