The i15 Blood Gas and Chemistry Analysis System (including Blood Gas and Chemistry Analyzer, Calibrant Fluid Pack, Test Cartridge) is a portable, automated system that measures pH and blood gases (pCO2, pO2), electrolytes (Na+, K+, Ca++, Cl-) and hematocrit in arterial and venous whole blood samples with lithium heparin or calcium balanced heparin. The system is intended for in-vitro diagnostic use only by trained health care professionals in a laboratory environment, near patient or point-of-care settings.

pH, pCO2, pO2: Whole blood measurement of certain gases in whole blood, or pH of whole blood, is used in the diagnosis and treatment of life-threatening acid-base and/or oxygenation disturbances.
Hct: Whole blood measurements of the packed cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red blood cells)
Na+: Sodium measurement is used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, or diseases involving electrolyte imbalance.
K+: Potassium measurement is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels
Cl-: Chloride measurement is used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Ca++: Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

The EDAN i15 Calibrant Fluid Pack is intended for the calibration of pH, pO2, pCO2, Na+, K+ Ca++, Cl-, and Hct as part of the EDAN i15 Blood Gas and Chemistry Analysis System.

The EDAN i15 Blood Gas and Electrolyte Controls are external multi-analyte quality control material intended to be used for the verification of correct operation and measurement of the EDAN i15 Blood Gas and Electrolyte Analyze, together with i15 Calibrant Fluid Pack and i15 Test Cartridge for the analysis of pH, blood gases (pCO2 pO2), and electrolytes (Na+, K+, Ca++, and Cl').

The EDAN i15 Hematocrit Controls are intended to be used for the verification of correct operation and measurement of the EDAN i15 Blood Gas and Chemistry Analysis System, together with i15 Calibrant Fluid Pack and i15 Test Cartridge for the analysis of hematocrit.

Device Description

The EDAN i15 Blood Gas and Chemistry Analysis System, including the Blood Gas and Chemistry Analyzer, Calibrant Fluid Pack, Test Cartridge, and Quality Controls) is a system for in-vitro analysis of whole blood, delivering quantitative results for panels of tests determined by the Test Cartridge type used in the measurement. The Analyzer incorporates a large graphical user interface with a large color touch screen interfacing the analyzer electronic, Test Cartridge (containing the sensors) and Calibrant Fluid Pack. The sensors, flow path and waste are integrated into a single-use Test Cartridge. The calibration solution is contained in the Calibrant Fluid Pack which is available in versions for 50 or 100 tests. The product, consumables, installation instructions and packaging are designed for easy customer installation and operation.

The EDAN i15 Analyzer accepts lithium- or calcium-balanced heparinized whole blood samples from syringes and capillary tube. The minimum volume for samples from both syringe and capillary tube is 140 µL.

As with the predicate device, the EDAN i15 Blood Gas and Chemistry Analysis System is microprocessor-based and incorporates traditional sensor technology for measurement.

pH, pCO2, Na*, K*, Cl , and Ca** (potentiometric measurement) .
pO2 (amperometric measurement)
Hct (conductivity measurement) ●

The Test Cartridge is available in three (3) versions, with different test panels, but with identical sample paths and calibration fluid:
BG8: pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct
BG3: pH, pCO2, pO2
BC4: Na+, K+, Cl-, Ca++, Hct

The Test Cartridge aspirates the sample directly from a syringe, or capillary fitted with an adaptor, and requires a minimum sample volume of 140 µL.

AI/ML Overview

The provided text describes the performance testing and acceptance criteria for the EDAN i15 Blood Gas and Chemistry Analysis System.

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Measurand	Acceptance Criteria for Linearity (Slope, Intercept, r-value)	Reported Linearity Performance (Syringe) (Slope, Intercept, r-value)	Reported Linearity Performance (Capillary) (Slope, Intercept, r-value)	Acceptance Criteria for Interferents	Reported Interferent Performance (Examples of significant interference listed below)
Linearity	Na+	Slope [0.95, 1.05], r-value ≥ 0.975	0.9923, -1.38, 0.9983	1.0059, -3.06, 0.9986	-	-
	K+	Slope [0.95, 1.05], r-value ≥ 0.975	0.9886, 0.08, 0.9997	1.0013, -0.01, 0.9998	-	-
	Cl-	Slope [0.95, 1.05], r-value ≥ 0.975	1.0028, -1.59, 0.9993	0.9965, -1.59, 0.9992	-	-
	Ca++	Slope [0.95, 1.05], r-value ≥ 0.975	0.9848, -0.05, 0.9981	0.9771, -0.06, 0.9968	-	-
	pH	Slope [0.95, 1.05], r-value ≥ 0.975	0.9842, 0.11, 0.9996	1.0039, -0.03, 0.9995	-	-
	pCO2	Slope [0.95, 1.05], r-value ≥ 0.975	0.9533, 0.62, 0.9969	0.9999, -0.06, 0.9992	-	-
	pO2	Slope [0.95, 1.05], r-value ≥ 0.975	0.9969, -6.16, 0.9993	1.0174, -5.40, 0.9997	-	-
	Hct	Slope [0.95, 1.05], r-value ≥ 0.975	0.9687, 1.54, 0.9981	0.9623, 1.51, 0.9984	-	-
Specificity/Interference	pH	Absolute difference < 0.02 pH Units	Acetaminophen (-0.034), Bromide (-0.027), Calcium Chloride (-0.024 at pH 7.3), Ethanol (-0.024), Hematocrit (-0.022), Heparin (-0.034 at pH 7.3), Hydroxycarbamide (-0.031 at pH 7.3), Iodide (-0.025 at pH 7.3), Potassium Chloride (-0.036), Sodium Chloride (-0.024/-0.021), Sodium Oxalate (-0.032 at pH 7.3)
	pCO2	Percent Bias < 8%	Acetaminophen (10.15%), Acetylsalicylic acid (8.01%), Ethanol (9.54%), Iodide (-10.00%/-8.69%), Potassium Chloride (11.15%), Bicarbonate (-18.40%/-17.44%)
	pO2	Percent Bias < 9%	Acetylsalicylic acid (-10.11%), Hematocrit (12.13%), Lactic Acid (9.74%), pCO2 (9.60%), Salicylic acid (14.98%), Sodium Chloride (9.22%), Bicarbonate (-14.46%)
	Na+	Percent Bias < 3%	Calcium Chloride (3.26%/4.99%), Dobutamine hydrochloride (5.62%)
	K+	Percent Bias < 10%	Acetylsalicylic acid (17.21%), Dobutamine hydrochloride (13.97%), Hydroxybutyrate (12.28%/16.87%), Iodide (24.20%), Lactic Acid (13.05%), pCO2 (10.13%), Salicylic acid (10.54%), Bicarbonate (21.51%/10.31%)
	Ca++	Percent Bias < 10%	Halothane (11.20%), Heparin (-12.68%/-14.06%), Magnesium Chloride (13.91%/16.86%), Bicarbonate (-27.07%/-21.17%), Phosphate (-12.14%/-12.34%), Sodium Oxalate (-94.16%/-86.21%)
	Cl-	Percent Bias < 5%	Acetylsalicylic acid (7.72%/5.11%), Albumin (5.13%/7.19%), Bromide (6.38%), Iodide (-7.60%/-11.76%), Potassium Thiocyanate (10.81%/13.41%), Salicylic acid (11.28%/9.88%), Bicarbonate (7.72%/8.79%), Sodium Oxalate (5.01%/6.47%)
	Hct	Percent Bias < 6%	Albumin (10.29%/13.65%), Bromide (-6.98%), Calcium Chloride (-7.23%/-6.13%), Dextran (10.24%), Dobutamine hydrochloride (7.76%), Ethanol (-6.61%), Magnesium Chloride (-6.40%/-9.39%), Potassium Chloride (-6.27%), Sodium Chloride (-6.36%), Bicarbonate (-7.72%)
Detection Limits (ionized Ca)	Ionized Calcium	LoB/LoD/LoQ consistent with claimed range	LoB: 0.09 mmol/L, LoD: 0.11 mmol/L, LoQ: 0.11 mmol/L	-	-	-

2. Sample size used for the test set and the data provenance

Linearity Studies: 7 levels of modified whole blood samples were used for each measurand. The data provenance is "Whole, venous blood samples collected from healthy volunteers" and samples were modified to achieve different concentration levels.
Imprecision in External Controls: 80 replicates for each level of blood gas and electrolyte control, and 80 replicates for each level of hematocrit control.
Precision in Whole Blood (Hct): 6 levels, with 10 replicates per level on 3 analyzers (total 30 results per level), from "heparinized venous whole blood samples collected from eight volunteers".
Precision in Whole Blood (Other analytes): 3 levels (implicitly, as 3 healthy volunteers mentioned), each run in 10 replicates on each of 3 analyzers (total 30 results). Samples were "venous whole blood collected from 3 healthy volunteers".
Comparison of Syringe and Capillary Measurement: 180 samples (derived from 6 levels of blood, each with 10 replicates on 3 instruments), using "Whole blood venous samples from healthy volunteers".
Specificity / Interference Testing: 7 replicates of both spiked and unspiked samples were tested.
Method Comparison: 488 (pH), 483 (pCO2), 486 (pO2), 486 (Na+), 487 (K+), 484 (Cl-), 485 (Ca++), 487 (Hct) patient samples from 4 Point-of-Care (POC) sites and 3 laboratory sites. Samples were "discarded patient samples collected into either B-D Vacutainer lithium heparin tubes or B-D balanced heparin arterial sampling syringes". This indicates retrospective data. Data provenance (country of origin) is not explicitly stated.
Determination of Detection Limits for ionized Calcium: 120 measurements for LoB, and 120 measurements for LoD and LoQ, using zero-level and low-level whole blood samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document primarily relies on comparisons to reference methods or predicate devices to establish ground truth for the performance of the EDAN i15 system.

Linearity studies: Ground truth for linearity was established by various reference methods or comparative measurements:
- Electrolyte values: "compared to those calculated from serial dilution of high and low concentration blood samples".
- pCO2 and pO2: "against those determined by tonometry".
- pH: "compared against parallel measurement on a Radiometer ABL 800".
- Hematocrit: "compared the PCV% obtained by microhematocrit centrifuge". These are technical reference standards, not human experts.
Method Comparison: The predicate device, Siemens RapidPoint 400 System, was used as the comparator for patient samples. The quality control materials used (RNA Medical QC823 and QC900) also have assigned values. These are established reference methods and devices, not human subject matter experts.
Clinical Site Testing: The study involved "11 persons fulfilling the minimum requirements for education and training to perform moderately complex testing in accordance with CLIA." These are operators, not experts establishing ground truth via consensus.

Therefore, no information on human experts establishing the ground truth for the test set using a consensus approach is provided; instead, instrumental or established reference methods/devices were used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No information on an adjudication method involving multiple readers or experts is provided in the document. The ground truth was established by comparison to reference methods or a predicate device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No multi-reader multi-case (MRMC) comparative effectiveness study was done. This document describes the performance of a blood gas and chemistry analysis system, which is an automated device, not an AI-assisted diagnostic imaging tool that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, the device evaluated is a standalone automated blood gas and chemistry analysis system (EDAN i15). The performance metrics provided (linearity, imprecision, interference, method comparison) are indicative of the algorithm's (device's) performance without human interpretation or intervention in the measurement process itself, beyond sample introduction and operation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used was based on:

Reference Methods/Standards: For linearity, this included calculations from serial dilution, tonometry for blood gases, measurement by Radiometer ABL 800 for pH, and microhematocrit centrifuge for Hct.
Predicate Device: For method comparison, the Siemens RapidPoint 400 System was used as the comparator, representing an established and cleared device.
Assayed Control Materials: For imprecision studies, external quality control materials (EDAN i15 Blood Gas and Electrolyte Control and EDAN i15 Hematocrit Control) with assigned values were used.

8. The sample size for the training set

The document does not explicitly state a "training set" size. As this is a medical device for in-vitro diagnostics and not a machine learning algorithm that undergoes traditional "training," the concept of a training set in the AI sense does not directly apply. The development of such a device involves internal verification and validation, but specific "training set" details are not provided in this regulatory summary.

9. How the ground truth for the training set was established

As noted in point 8, the concept of a "training set" in the AI sense is not directly applicable here. The device's performance characteristics (e.g., calibration, measurement principles, stability) are established through rigorous engineering, chemical, and biological testing during its development and validation. The "ground truth" for the device's operational parameters and calibration solutions (e.g., Calibrant Fluid Pack) is established by using primary and secondary standards traceable to NIST or other recognized standards (as detailed in the "Traceability" section, page 23). For the EDAN i15 Controls, value assignment is performed by parallel testing against existing, validated lots and applying bias to determine acceptable ranges (page 24-25).

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 15, 2016

EDAN INSTRUMENTS, INC. C/O RANDY BYRD RANDY BYRD, LLC 1 BLUEBERRY HILL WAY PEPPERELL MA 01463-4200

Re: K151978 Trade/Device Name: EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control Regulation Number: 21 CFR 862.1120 Regulation Name: Blood Gases (pCO2, pO2) and Blood pH System Regulatory Class: II Product Code: CHL, JGS, CEM, JFP, CGZ, GKF, JIX, JJS, GLK Dated: July 8, 2016 Received: July 11, 2016

Dear Randy Byrd:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); good manufacturing practice requirements

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as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Katherine Serrano -S

For:

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151978

Device Name

EDAN i15 Blood Gas and Chemistry Analysis System

Indications for Use (Describe)

The i15 Blood Gas and Chemistry Analysis System (including Blood Gas and Chemistry Analyzer, Calibrant Fluid Pack, Test Cartridge) is a portable, automated system that measures pH and blood gases (pCO2, pO2), electrolytes (Na+, K+, Ca++, Cl-) and hematocrit in arterial and venous whole blood samples with lithium heparin or calcium balanced heparin. The system is intended for in-vitro diagnostic use only by trained health care professionals in a laboratory environment, near patient or point-of-care settings.

pH, pCO 2 ,pO 2 :	Whole blood measurement of certain gases in whole blood, or pH of whole blood, is used in the diagnosis and treatment of life-threatening acid-base and/or oxygenation disturbances.
Hct:	Whole blood measurements of the packed cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red blood cells)
Na + :	Sodium measurement is used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, or diseases involving electrolyte imbalance.
K + :	Potassium measurement is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels
Cl - :	Chloride measurement is used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Ca ++ :	Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

For In Vitro Diagnostic Use

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
-----------------------------------------------------------------------------------------------------------	----------------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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PRAStaff@fda.hhs.gov

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Indications for Use

510(k) Number (if known) K151978

Device Name EDAN i15 Calibrant Fluid Pack

Indications for Use (Describe)

The EDAN i15 Calibrant Fluid Pack is intended for the calibration of pH, pO2, pCO2, Na * K Ca *, Cl , and Hct as part of the EDAN i15 Blood Gas and Chemistry Analysis System.

For In Vitro Diagnostic Use

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K151978

Device Name

EDAN i15 Blood Gas and Electrolyte Control

Indications for Use (Describe)

For In Vitro Diagnostic Use

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K151978

Device Name EDAN i15 Hematocrit Control

Indications for Use (Describe)

For In Vitro Diagnostic Use

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary1

(a)(1) Submitter's name, address

EDAN Instruments, Inc. 3/F-B, Nanshan Medical Equipments Park 1019# Nanhai Road Shenzhen, 518067 P.R. China

Registration Number 3003971136

Application Correspondent Tracy Yue, +86.755.76856469

Date of Preparation of this Summary:

14 July 2016

(2) Device trade or proprietary name: EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control and EDAN i15 Hematocrit Control.

Device common or usual name: Blood Gases (pCO2, PO2) and blood pH Test System, Electrolyte Analyzer; Calibrator, multi-analyte mixture; Controls for Blood Gases, Control, Hematocrit

Classification Name: Multiple

		Product	Regulation
Classification Name	Review Panel	Code	Number	Class
Blood gases (PCO2, PO2) and blood pH test system	Clinical Chemistry	75 CHL	862.1120	2
Sodium test system	Clinical Chemistry	75 JGS	862.1665	2
Potassium test system	Clinical Chemistry	75 CEM	862.1600	2
Chloride test system	Clinical Chemistry	75 CGZ	862.1170	2
Calcium test system	Clinical Chemistry	75 JFP	862.1145	2
Automated hematocrit instrument	Hematology	81 GKF	864.5600	2
Calibrators	Clinical Chemistry	75 JIX	862.1150	2
Controls for Blood Gases (Assayed and Unassayed)	Clinical Chemistry	75 JJS	862.1660	1
Control, Hematocrit	Hematology	81 GLK	864.8625	2

(3) Substantial Equivalence

The EDAN i15 Blood Gas and Chemistry Analysis System, including the Blood Gas and Chemistry Analyzer, Calibrant Fluid Pack, Test Cartridge, and Quality Controls) is substantially equivalent in function, safety and efficacy to currently marketed devices for the same intended use as shown in the table, below.

Predicate Devices: K002738 – Siemens (Bayer) Rapidpoint 400 System, including calibrators
K943754 – RNA Medical QC823 Blood Gas, Electrolyte, Metabolite Control
K955630 – RNA Medical QC900 Hematocrit Control

4 This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

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Comparison of Predicate and Candidate Devices

Predicate Device:	K002738 Siemens (Bayer) Rapidpoint 400 System			Candidate Device:	EDAN i15 Blood Gas and Chemistry Analysis System
	Characteristic
	Intended Use
	For the measurement of pH, pCO2, pO2, Na+, K+, Ca++, Cl- and Hct in whole blood samples.			Same
	Test Principle
	pH and pCO2: potentiometric			Same
	pO2: amperometric			Same
	Na+, K+, Ca++, Cl-: potentiometric, ion-selective			Same
	Hematocrit: conductivity			Same
	Sensor Technology
	Amperometric and potentiometric thick film microelectrodes			Same
	Sample Types
	Heparinized whole blood			Same
	Sample Introduction
	Syringe and capillary, by aspiration			Same
	Sample Volumes
	100 μL (syringe and capillary)			140 μL (syringe and capillary)
	Measurement Range
	Parameter	Range	Default units	Parameter	Range	Default units
	pH	6.500 - 7.800	(pH units)	pH	6.500 - 7.800	(pH units)
	pCO2	5.0 - 200.0	mmHg	pCO2	10 - 150	mmHg
	pO2	10.0 - 700.0	mmHg	pO2	10 - 700	mmHg
	Na+	100.0 - 200.0	mmol/L	Na+	100 - 180	mmol/L
	K+	0.50 - 15.00	mmol/L	K+	2.0 - 9.0	mmol/L
	Ca++	0.20 - 5.00	mmol/L	Ca++	0.25 - 2.50	mmol/L
	Cl-	65 - 140	mmol/L	Cl-	65 - 140	mmol/L
	Hct	12 - 75	%	Hct	13 - 72	%
	Glu	20 - 750	mg/dL	N/A
	User Interface, Printer
	Menu-driven color touch screen display			Same
	Bar-code scanner			Same
	Thermal printer			Same
	System Operating Temperature, Humidity
	15 - 32°C, 5% to 85% (non-condensing)			10 – 31° C, 25% to 80% (non-condensing)
Predicate Device:	K002738 Siemens (Bayer) 400Measurement Cartridge			Candidate Device:	EDAN i15 Blood Gas and ChemistryAnalysis System Calibrant Fluid Pack

Device:	Measurement Cartridge	Device:	Analysis System Calibrant Fluid Pack
Intended Use
The measurement cartridge is intended to be usedfor the calibration of sensors used for thequantitative measurement of pH, blood gases,electrolytes and hematocrit.		Same
Configuration
Three solutions for the calibration of the sensorsand a reference solution contained in Mylar andaluminum foil bags, housed in a protective, self-contained, molded plastic disposable container.		One solution for the calibration of the sensorscontained in a Mylar and aluminum foil bag, housedin a protective, self-contained, molded plasticdisposable container.

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Predicate Device:	K943754 RNA Medical QC823 Blood Gas, Electrolyte and Metabolite Quality Control	Candidate Device:	EDAN Blood Gas and Chemistry Quality Control
Intended Use	To evaluate the operation of the analyzer and to monitor the measurement of pH and blood gases (pCO2, pO2, and electrolytes (Na+, K+, Ca++, Cl-)		Same
Configuration	QC 823 is provided in three (3) levels for monitoring analyzer performance at different points within the clinical range. It is packaged in sealed glass ampoules, each containing 2.5 mL of solution. Ampoules are packaged thirty (30) per box.		Same, except packaged with 5 ampoules per box.
Analytes	pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Mg++, glucose, lactate, and BUN (urea)		Same, except assay provided only for pH, pCO2, pO2, Na+, K+, Cl- and Ca++
Predicate:	K955630 RNA Medical Hematocrit Controls	Candidate:	EDAN Blood Gas and Chemistry System Hematocrit Controls
Intended Use	To evaluate the operation and to monitor the measurement of hematocrit by electrical conductivity.		Same
Configuration	QC 900 is provided in two (2) levels (Low and High) for monitoring analyzer performance at different points within the clinical range. It is packaged in sealed glass ampoules, each containing 1.7 mL of solution. Ampoules are packaged twenty (20) per box (10 of each level).		Same, except each single level is packaged in a convenient 5-ampoule box.
Analytes	Hematocrit (%)		Same
Active Ingredients	Salts and conductivity modifiers		Same

(4) Description of the new device.

Test Cartridge

As with the predicate device, the EDAN i15 Blood Gas and Chemistry Analysis System is microprocessor-based and incorporates traditional sensor technology for measurement.

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pH, pCO2, Na*, K*, Cl , and Ca** (potentiometric measurement) .
pO2 (amperometric measurement)
Hct (conductivity measurement) ●

The Test Cartridge is available in three (3) versions, with different test panels, but with identical sample paths and calibration fluid:

Test Cartridge Type	Measured Parameters
BG8	pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct
BG3	pH, pCO2, pO2
BC4	Na+, K+, Cl-, Ca++, Hct

The Test Cartridge aspirates the sample directly from a syringe, or capillary fitted with an adaptor, and requires a minimum sample volume of 140 µL.

Measured Parameters

The EDAN i15 Blood Gas and Chemistry Analysis System measures blood pH, pCO2, pO2, sodium, potassium, chloride, ionized calcium and hematocrit.

Calculated Parameters

Symbol	Description
cH+	Hydrogen ion concentration
cH+(T)	Hydrogen ion concentration corrected for entered patient temperature
pH (T)	pH value corrected for entered patient temperature
pCO2 (T)	pCO2 corrected for entered patient
pO2 (T)	pO2 corrected for entered patient temperature
HCO3 act	Bicarbonate ion concentration
HCO3 std	Bicarbonate ion concentration normalized to a pCO2 of 40mmHg
BB (B)	Buffer base
BE (B)	Base excess (B) BE (ecf) Base excess (ecf) ctCO2 Total carbon dioxide
Ca++ (7.4)	The ionized calcium concentration of blood normalized to pH 7.4
AnGap	An approximation of the difference between measured cations and measuredanions in the sample
tHb (est)	An estimation of the hemoglobin contained in the sample
sO2 (est)	An estimation of hemoglobin oxygen saturation: a ratio of the amount ofhemoglobin bound to oxygen to the total amount of hemoglobin able to bindoxygen
pO2 (A-a)	Alveolar-arterial oxygen tension difference
pO2 (A-a) (T)	Alveolar-arterial oxygen tension difference corrected for entered patienttemperature
pO2 (a/A)	Arterial-alveolar oxygen tension ratio
pO2 (a/A) (T)	Arterial-alveolar oxygen tension ratio corrected for entered patient temperature
RI	Respiratory index: the ratio of the alveolar-arterial blood oxygen-pressure differenceto arterial pO2
RI (T)	Respiratory index: the ratio of the alveolar-arterial blood oxygen-pressure differenceto arterial pO2 when both values are corrected for patient temperature
pO2/FIO2	The ratio of arterial pO2 to the fraction of inspired oxygen
pO2 (T)/FIO2	The ratio of arterial pO2 to the fraction of inspired oxygen corrected for the enteredpatient temperature

Indications for Use

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electrolytes (Na , K , C , Cl ) and hematocrit in arterial and venous whole blood samples with lithium heparin or calcium balanced heparin. The system is intended for in-vitro diagnostic use only by trained health care professionals in a laboratory environment, near patient or point-of-care settings.

pH, pCO2, Whole blood measurement of certain gases in whole blood, or pH of whole blood, is used in pO2: the diagnosis and treatment of life-threatening acid-base and/or oxygenation disturbances.

Hct: Whole blood measurements of the packed cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red blood cells)
Nat: Sodium measurement is used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, or diseases involving electrolyte imbalance.
Kt: Potassium measurement is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels
Cl : Chloride measurement is used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Ca**: Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

The EDAN i15 Calibrant Fluid Pack is intended for the calibration of pH, pO2, pCO2, Na*, K* Ca**, Cl , and Hct as part of the EDAN i15 Blood Gas and Chemistry Analysis System.

Summary of the Technological Characteristics

The EDAN i15 Blood Gas and Chemistry Analysis System is substantially equivalent to the previously cleared Siemens RapidPoint 400 Test System in intended use. The test principle, sensor technology, sample types and mode of sample introduction are the same for these system, and measurement is shown to be equivalent in this submission. The results of software validation and performance verification testing confirmed the EDAN i15 Blood Gas and Chemistry Analysis System, including Blood Gas and Chemistry Analyzer, Calibrant Fluid Pack, and Test Cartridge, is safe and effective for it intended use and the EDAN i15 Blood Gas and Chemistry Analysis system is substantially equivalent to that of the Siemens RapidPoint 400 Blood Gas Electrolyte System, including the Measurement Cartridge, K002738 (predicate device).

The EDAN i15 Calibrator Fluid Pack is substantially equivalent to the Siemens 400 Measurement Cartridge previously cleared with the Siemens RapidPoint 400 Test System in configuration and in support for the calibration and measurement of equivalent panels of measurands.

The EDAN i15 Blood Gas and Electrolyte Control is substantially equivalent to the previously cleared RNA

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Medical Blood Gas, Electrolyte and Metabolite Control K943754 (predicate device) in formulation, measurands and primary (glass ampoule) packaging, but packaged in convenient 5-ampoule packages.

The EDAN i15 Hematocrit Control is substantially equivalent to the previously cleared RNA Medical Hematocrit Control K955630 (predicate device) in formulation, measurands and primary (glass ampoule) packaging, but packaged in convenient 5-ampoule packages.

Summary of Performance Testing

Bench testing was completed to demonstrate the EDAN i15 System is substantially equivalent to the Siemens RapidPoint 400 Blood Gas and Electrolyte System in performance, safety and efficacy. The bench testing included:

Method Comparison Studies, Linearity and Analytical Measuring Range ●
Imprecision/Reproducibility Studies
Specificity/Interference Testing
Detection Limit ●

The results of that testing confirm the performance of the EDAN i15 Blood Gas and Chemistry Analysis System, (including Blood Gas and Chemistry Analyzer, Calibrant Fluid Pack, and Test Cartridge), is substantially equivalent to that of the previously cleared Siemens (Bayer) RapidPoint 400 Test System, including Measurement Cartridge (predicate device).

a. Linearity Studies

Whole, venous blood samples collected from healthy volunteers in vacuum blood collection tubes with lithium heparin were modified to obtain a range of values for each measurand approaching their analytical measurement range by the addition of isotonic electrolyte solution for electrolytes, tonometry with various gas mixtures for blood gases and pH, and by mixing with erythrocyte concentrated for depleted plasma to obtain an range of hematocrit. Criteria for acceptance is a slope between 0.95 and 1.05 and r-value ≥ 0.975. Electrolyte values were compared to those calculated from serial dilution of high and low concentration blood samples, pO2 and pCO2 against those determined by tonometry, pH was compared against parallel measurement on a Radiometer ABL 800, while hematocrit was compared the PCV% obtained by microhematocrit centrifuge. The evaluation demonstrated equivalent, linear performance over the analytical measurement range for all measurands in samples from syringes and from glass capillary tubes.

Whole Blood from Syringe
Measurand	No ofLevels	ClaimedMeasuring Range	Specimen Range	% ofclaimedrange	Slope	Intercept	r value
Na+	7	100 - 180	94 - 185	114%	0.9923	-1.38	0.9983
K+	7	2.0 - 9.0	1.7 - 10.2	120%	0.9886	0.08	0.9997
Cl-	7	65 - 140	58 - 176	158%	1.0028	-1.59	0.9993
Ca++	7	0.25 - 2.50	0.23 - 2.94	120%	0.9848	-0.05	0.9981
pH	7	6.500 - 7.800	6.455 - 7.944	115%	0.9842	0.11	0.9996
p CO2	7	10 - 150	3 - 149	104%	0.9533	0.62	0.9969
p O2	7	10 - 700	6 - 716	103%	0.9969	-6.16	0.9993
Hct	7	13 - 72	3 - 77	125%	0.9687	1.54	0.9981

Linearity across claimed measurement range in samples introduced from Syringe.

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Whole Blood from Capillary
				% of
	No of	Claimed		claimed
Measurand	Levels	Measuring Range	Specimen Range	range	Slope	Intercept	r value
Na+	7	100 - 180	94 - 185	114%	1.0059	-3.06	0.9986
K+	7	2.0 - 9.0	1.9 - 10.0	116%	1.0013	-0.01	0.9998
Cl-	7	65 - 140	59 - 175	155%	0.9965	-1.59	0.9992
Ca++	7	0.25 - 2.50	0.24 - 2.97	121%	0.9771	-0.06	0.9968
pH	7	6.500 - 7.800	6.464 - 7.978	116%	1.0039	-0.03	0.9995
pCO2	7	10 - 150	2 - 150	105%	0.9999	-0.06	0.9992
pO2	7	10 - 700	7 - 717	103%	1.0174	-5.40	0.9997
Hct	7	13 - 72	4 - 76	122%	0.9623	1.51	0.9984

Linearity across claimed measurement range in samples introduced from glass Capillary.

b . Imprecision in External Controls

Imprecision was evaluated by running 3 levels of EDAN i15 Blood Gas and Electrolyte Control and 2 levels of EDAN i15 Hematocrit Control in duplicate each day for a total of 20 runs on one EDAN i15 Blood Gas and Chemistry Analysis System. The protocol was based on methods described in CLSI EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second edition.

pH Precision in Aqueous Blood Gas and Electrolyte Control
	Mean		Within-Run	Within-Run	Total Imprecision	Total Imprecision
Sample	(pH units)	N	SD	CV	SD	CV
Level 1	7.153	80	0.012	0.17 %	0.012	0.17 %
Level 2	7.410	80	0.013	0.18 %	0.013	0.18 %
Level 3	7.598	80	0.008	0.11 %	0.009	0.12 %
			pCO2 Precision in Aqueous Blood Gas and Electrolyte Control
	Mean		Within-Run	Within-Run	Total	Total Imprecision
Sample	(mmHg)	N	SD	CV	Imprecision SD	CV
Level 1	62.8	80	2.11	3.36 %	2.40	3.82 %
Level 2	38.8	80	2.11	5.45 %	2.33	6.02 %
Level 3	20.5	80	0.80	3.91 %	0.85	4.13 %
	pO2 Precision in Aqueous Blood Gas and Electrolyte Control
	Mean		Within-Run	Within-Run	Total	Total Imprecision
Sample	(mmHg)	N	SD	CV	Imprecision SD	CV
Level 1	71.4	80	2.67	3.73 %	2.68	3.75 %
Level 2	106.2	80	1.84	1.73 %	2.50	2.35 %
Level 3	149.2	80	2.59	1.74 %	3.33	2.23 %
			Na+ Precision in Aqueous Blood Gas and Electrolyte Control
	Mean		Within-Run	Within-Run	Total	Total Imprecision
Sample	(mmol/L)	N	SD	CV	Imprecision SD	CV
Level 1	111.8	80	1.29	1.15 %	1.32	1.18 %
Level 2	133.0	80	0.95	0.71 %	1.14	0.86 %
Level 3	158.5	80	1.51	0.95 %	1.44	0.91 %

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K+ Precision in Aqueous Blood Gas and Electrolyte Control
Sample	Mean (mmol/L)	N	Within-Run SD	Within-Run CV	Total Imprecision SD	Total Imprecision CV
Level 1	1.91	80	0.040	2.11 %	0.040	2.07 %
Level 2	4.34	80	0.047	1.09 %	0.052	1.20 %
Level 3	6.34	80	0.073	1.16 %	0.065	1.02 %
Cl- Precision in Aqueous Blood Gas and Electrolyte Control
Sample	Mean (mmol/L)	N	Within-Run SD	Within-Run CV	Total Imprecision SD	Total Imprecision CV
Level 1	75.9	80	0.91	1.20 %	0.93	1.22 %
Level 2	92.3	80	1.07	1.16 %	1.08	1.17 %
Level 3	121.7	80	0.66	0.54 %	0.69	0.57 %
Ca++ Precision in Aqueous Blood Gas and Electrolyte Control
Sample	Mean (mmol/L)	N	Within-Run SD	Within-Run CV%	Total Imprecision SD	Total Imprecision CV%
Level 1	1.37	80	0.04	3.09	0.05	3.47
Level 2	1.23	80	0.02	1.54	0.03	2.42
Level 3	0.61	80	0.02	3.10	0.02	3.66
Hct Precision in Aqueous Hematocrit Control
Sample	Mean (%)	N	Within-Run SD	Within-Run CV	Total Imprecision SD	Total Imprecision CV
Low	19.2	80	0.57	2.97 %	0.73	3.82 %
High	46.8	80	0.58	1.24 %	0.54	1.16 %

Precision in Whole Blood C.

Hematocrit Venous Whole Blood Precision

An in-house with-in run precision study was performed on heparinized venous whole blood samples collected from eight volunteers. Six levels were prepared (one on each day of 6 days) in order to cover the measuring range of hematocrit. Each sample was run in replicates of 10 on 3 EDAN i15 analyzers, using 3 reagent lots, over a period of 6 days (one level run per day) for a total of 30 results per level. The with-in run precision results for of the six levels of whole blood tested from both syringe and capillary tube is presented in the table below:

n = 30		Syringe		Capillary
Hct
Level	Mean (%)	SD	%CV	Mean (%)	SD	%CV
ਹ	18.0	1.1	6.3	18.4	1.1	5.9
2	30.6	0.6	1.8	31.1	0.8	2.4
3	47.1	0.8	1.7	48.0	1.1	2.3
4	51.4	0.6	1.2	52.5	0.7	1.3
ട	54.0	0.6	1.2	53.9	0.9	1.6
6	62.9	0.9	1.4	63.1	0.8	1.3

Venous whole blood within-run precision for Hct

An in-house precision study was performed utilizing 3 EDAN i15 Blood Gas and Chemistry Analysis System with venous whole blood collected from 3 healthy volunteers. The whole blood was tonometered to nominal gas values. The remainder of the analytes were not altered. The samples were run in replicates of 10 on each of the three analyzers for a total of 30 results. The results of the combined precision data is summarized below:

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n = 30		Syringe			Capillary
		Mean(%)	SD	%CV	Mean (%)	SD	%CV
Parameter	pH	7.325	0.015	0.20	7.322	0.016	0.21
	pCO2 (mmHg)	44.3	1.1	2.6	43.7	1.2	3.8
	pO2 (mmHg)	150.8	4.5	3.0	148.7	4.1	2.8
	Na+ (mmol/L)	139.1	0.9	0.7	139.2	0.9	0.6
	K+ (mmol/L)	3.24	0.06	1.9	3.35	0.08	2.5
	Ca++ (mmol/L)	1.19	0.03	2.7	1.17	0.03	2.3
	Cl- (mmol/L)	103.5	1.8	1.7	103.5	2.0	1.1
	Hct (%)	47.1	0.8	1.7	48.1	1.1	2.2

Venous whole blood within-run precision

d. Comparison of Syringe and Capillary Measurement

Whole blood venous samples from healthy volunteers were evaluated to demonstrate the measurement results from samples introduced from syringes and capillary tubes are equivalent. Six levels of blood were prepared to provide a range of measurement values for electrolytes and hematocrit, and tonometered with precision gas mixtures to attain a range of pCO2 and PO2 values and analyzed over numerous days on three (3) EDAN i15 instruments with 10 replicates on each of six (6) levels of prepared blood samples introduced from capillary tubes as compared to introduced from syringes.

Measurand	N	sample rangetested	Slope	Intercept	r-value	Bias
pH	180	7.036 - 7.689	0.9855	0.1056	0.9936	-0.001
pCO2 (mmHg)	180	6.7 - 119.1	0.9870	0.0377	0.9953	-0.6
pO2 (mmHg)	180	15.0 - 749.0	1.0177	-1.0704	0.9941	3.3
Na+ (mmol/L)	180	105 - 176	0.9716	4.3119	0.9954	0.3
K+ (mmol/L)	180	2.8 - 10.6	0.9848	0.0339	0.9981	-0.04
Ca++ (mmol/L)	180	0.86 - 3.16	0.9813	-0.0213	0.9928	-0.05
Cl- (mmol/L)	180	76 - 164	0.9844	1.6184	0.9922	-0.2
Hct (%)	180	16 - 64	0.9933	0.8013	0.9968	0.5

Correlation in whole blood samples introduced from Capillary vs Syringe

e. Specificity / Interference Testing

An interference study was performed according to the CLSI guideline EP7-A2. The study used spiked and diluted human whole blood samples containing potential interferents for pH, pO2, pCO2, sodium, potassium, chloride, calcium, and hematocrit. Seven replicates of both the spiked and the unspiked sample were tested on two i15 Blood Gas and Chemistry System with one lot of test cartridges. The results of each replicate of the spiked and unspiked samples were compared and the percent bias between the results was calculated for all analytes except for pH for which absolute difference was calculated. The acceptance criteria used to evaluate if the substances significantly interfere with each analyte is shown in the table below:

Measurand	pH	pCO2	pO2	Na+	K+	Ca++	Cl-	Hct
EvaluationMethod	Absolutedifference	PercentBias	Percentbias	Percentbias	Percentbias	Percentbias	Percentbias	Percentbias
AcceptanceCriteria	< 0.02pH Units	< 8%	< 9%	< 3%	< 10%	< 10%	< 5%	< 6%

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Interfering Substance	Highest ConcentrationTested	Analytes Tested
Albumin	1.5 g/dL (added)	Na+, K+, Ca++, Cl-, Hct
Ascorbic acid (Vitamin C)	6.02 mg/dL	pCO2, pO2, Na+, K+, Ca++, Cl-, Hct
Benzylkonium Chloride	0.80 mg/dL	Na+, K+, Ca++, Cl-, Hct
Bilirubin	15 mg/dL	pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct
Calcium Chloride	27.75 mg/dL	pH, pCO2, pO2, Na+, K+, Hct
Cholesterol	500 mg/dL	pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct
Cysteine	12.12 mg/dL	pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct
Hemoglobin	500 mg/dL	pH, pCO2, pO2, Na+, Ca++, Cl-, Hct
Heparin lithium salt	11.76 mg/dL	pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct
Hydroxybutyrate	208 mg/dL	pCO2, pO2, Na+, Ca++, Cl-, Hct
Hydroxyurea	182.52 mg/dL	pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct
Ibuprofen	50 mg/dL	pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct
Lactic acid	59.40 mg/dL	pCO2, pO2, Na+, K+, Ca++, Cl-, Hct
Lithium	2.24 mg/dL	pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct
Ofloxacin	6 µg/mL	pH, pCO2, Na+, K+, Ca++, Cl-, Hct
Triglycerides	1500 mg/dL	pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct

The following table represents substances that were tested without significant effects on test results:

The following table represents substances that were tested that demonstrated a significant interference on test results. The table includes the range of % bias (absolute difference for pH) that was calculated between the 7 replicates spiked and unspiked samples for each analyte.

Measurand	Interfering Substance	ConcentrationTested	Blood SampleValue	Absolute Differencein pH Units
pH	Acetaminophen	20.01 mg/dL	pH: 7.5pH: 7.3	-0.034< 0.02
	Bromide	185.20 mg/dL	pH: 7.5pH: 7.3	-0.027< 0.02
	Calcium Chloride	27.27 mg/dL	pH: 7.5pH: 7.3	< 0.02 -0.024
	Ethanol	400 mg/dL	pH: 7.5pH: 7.3	-0.024< 0.02
	Hematocrit	20% PCV	pH: 7.5pH: 7.3	-0.022< 0.02
	Heparin	58.82 mg/dL	pH: 7.5pH: 7.3	< 0.02 -0.034
	Hydroxycarbamide(Hydroxyurea)	182.52 mg/dL	pH: 7.5pH: 7.3	< 0.02 -0.031
	Iodide	37.94 mg/dL	pH: 7.5pH: 7.3	< 0.02 -0.025
	Potassium Chloride	59.64 mg/dL	pH: 7.5pH: 7.3	-0.036< 0.02

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Measurand	Interfering Substance	Concentration Tested	Blood Sample Value	Absolute Difference in pH Units
pH	Sodium Chloride	117 mg/dL	pH: 7.5	-0.024
	Sodium Chloride	117 mg/dL	pH: 7.3	-0.021
pH	Sodium Oxalate	168 mg/dL	pH: 7.5	< 0.02
pH	Sodium Oxalate	168 mg/dL	pH: 7.3	-0.032
Measurand	Interfering Substance	Concentration Tested	Blood Sample Value	% Difference
pCO2	Acetaminophen	20.01 mg/dL	pCO2: 70 mmHg	10.15%
	Acetaminophen	20.01 mg/dL	pCO2: 40 mmHg	< 8%
pCO2	Acetylsalicylic acid	39.09 mg/dL	pCO2: 70 mmHg	8.01%
	Acetylsalicylic acid	39.09 mg/dL	pCO2: 40 mmHg	< 8%
pCO2	Ethanol	400 mg/dL	pCO2: 70 mmHg	9.54%
	Ethanol	400 mg/dL	pCO2: 40 mmHg	< 8%
pCO2	Iodide	37.94 mg/dL	pCO2: 70 mmHg	-10.00%
	Iodide	37.94 mg/dL	pCO2: 40 mmHg	-8.69%
pCO2	Potassium Chloride	59.64 mg/dL	pCO2: 70 mmHg	11.15%
	Potassium Chloride	59.64 mg/dL	pCO2: 40 mmHg	< 8%
pCO2	Bicarbonate (NaHCO3)	294 mg/dL	pCO2: 70 mmHg	-18.40%
	Bicarbonate (NaHCO3)	294 mg/dL	pCO2: 40 mmHg	-17.44%
pO2	Acetylsalicylic acid	39.09 mg/dL	pO2: 100 mg/dL	< 9%
	Acetylsalicylic acid	39.09 mg/dL	pO2: 70 mg/dL	-10.11%
pO2	Hematocrit	20% PCV	pO2: 100 mg/dL	< 9%
	Hematocrit	20% PCV	pO2: 70 mg/dL	12.13%
pO2	Lactic Acid	90 mg/dL	pO2: 100 mg/dL	< 9%
	Lactic Acid	90 mg/dL	pO2: 70 mg/dL	9.74%
pO2	pCO2	60 mmHg	pO2: 100 mg/dL	< 9%
	pCO2	60 mmHg	pO2: 70 mg/dL	9.60%
pO2	Salicylic acid	59.94 mg/dL	pO2: 100 mg/dL	< 9%
	Salicylic acid	59.94 mg/dL	pO2: 70 mg/dL	14.98%
pO2	Sodium Chloride	117 mg/dL	pO2: 100 mg/dL	< 9%
	Sodium Chloride	117 mg/dL	pO2: 70 mg/dL	9.22%
pO2	Bicarbonate (NaHCO3)	294 mg/dL	pO2: 100 mg/dL	-14.46%
	Bicarbonate (NaHCO3)	294 mg/dL	pO2: 70 mg/dL	< 9%

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Measurand	Interfering Substance	Concentration Tested	Blood SampleValue	% Difference
Na+	Calcium Chloride	55.50 mg/dL	Na+: 150 mmol/L	3.26%
			Na+: 130 mmol/L	4.99%
	Dobutamine hydrochloride	22.30 mg/dL	Na+: 150 mmol/L	< 3%
			Na+: 130 mmol/L	5.62%
K+	Acetylsalicylic acid	65.22 mg/dL	K+: 5 mmol/L	17.21%
			K+: 3 mmol/L	< 10%
	Dobutamine hydrochloride	22.30 mg/dL	K+: 5 mmol/L	< 10%
			K+: 3 mmol/L	13.97%
	Hydroxybutyrate	208 mg/dL	K+: 5 mmol/L	12.28%
			K+: 3 mmol/L	16.87%
	Iodide	37.94 mg/dL	K+: 5 mmol/L	< 10%
			K+: 3 mmol/L	24.20%
	Lactic Acid	90 mg/dL	K+: 5 mmol/L	13.05%
			K+: 3 mmol/L	< 10%
	p CO2	60 mmHg	K+: 5 mmol/L	10.13%
			K+: 3 mmol/L	< 10%
	Salicylic acid	29.97 mg/dL	K+: 5 mmol/L	10.54%
			K+: 3 mmol/L	< 10%
	Bicarbonate (NaHCO3)	294 mg/dL	K+: 5 mmol/L	21.51%
			K+: 3 mmol/L	10.31%
Ca++	Halothane	14.98 mg/dL	Ca++: 2 mmol/L	< 10%
			Ca++: 1 mmol/L	11.20%
	Heparin	58.82 mg/dL	Ca++: 2 mmol/L	-12.68%
			Ca++: 1 mmol/L	-14.06%
	Magnesium Chloride	47.61 mg/dL	Ca++: 2 mmol/L	13.91%
			Ca++: 1 mmol/L	16.86%
	Bicarbonate (NaHCO3)	294 mg/dL	Ca++: 2 mmol/L	-27.07%
			Ca++: 1 mmol/L	-21.17%
	Phosphate (NaH2PO4)	24 mg/dL	Ca++: 2 mmol/L	-12.14%
			Ca++: 1 mmol/L	-12.34%
	Sodium Oxalate	168 mg/dL	Ca++: 2 mmol/L	-94.16%
			Ca++: 1 mmol/L	-86.21%
Cl-	Acetylsalicylic acid	39.09 mg/dL	Cl-: 110 mmol/L	7.72%
			Cl-: 90 mmol/L	5.11%
	Albumin	3 g/dL (added)	Cl-: 110 mmol/L	5.13%
		Approx. 8 g/dL (total)	Cl-: 90 mmol/L	7.19%
	Bromide (NaBr)	185.20 mg/dL	Cl-: 110 mmol/L	< 5%
			Cl-: 90 mmol/L	6.38%

{20}------------------------------------------------

Measurand	Interfering Substance	Concentration Tested	Blood Sample Value	% Difference
Cl-	Iodide	37.94 mg/dL	Cl-: 110 mmol/L	-7.60%
	Iodide	37.94 mg/dL	Cl-: 90 mmol/L	-11.76%
	Potassium Thiocyanate	20.06 mg/dL	Cl-: 110 mmol/L	10.81%
	Potassium Thiocyanate	20.06 mg/dL	Cl-: 90 mmol/L	13.41%
	Salicylic acid	29.97 mg/dL	Cl-: 110 mmol/L	11.28%
	Salicylic acid	29.97 mg/dL	Cl-: 90 mmol/L	9.88%
	Bicarbonate (NaHCO3)	294 mg/dL	Cl-: 110 mmol/L	7.72%
	Bicarbonate (NaHCO3)	294 mg/dL	Cl-: 90 mmol/L	8.79%
	Sodium Oxalate	168 mg/dL	Cl-: 110 mmol/L	5.01%
	Sodium Oxalate	168 mg/dL	Cl-: 90 mmol/L	6.47%
Hct	Albumin	3 g/dL (added)approx. 8 g/dL (total)	Hct: 55% PCV	10.29%
	Albumin	3 g/dL (added)approx. 8 g/dL (total)	Hct: 35% PCV	13.65%
	Bromide (NaBr)	185.20 mg/dL	Hct: 55% PCV	< 6%
	Bromide (NaBr)	185.20 mg/dL	Hct: 35% PCV	-6.98%
	Calcium Chloride	55.50 mg/dL	Hct: 55% PCV	-7.23%
	Calcium Chloride	55.50 mg/dL	Hct: 35% PCV	-6.13%
	Dextran	3 g/dL	Hct: 55% PCV	< 6%
	Dextran	3 g/dL	Hct: 35% PCV	10.24%.
	Dobutamine hydrochloride	22.30 mg/dL	Hct: 55% PCV	< 6%
	Dobutamine hydrochloride	22.30 mg/dL	Hct: 35% PCV	7.76%
	Ethanol	400 mg/dL	Hct: 55% PCV	< 6%
	Ethanol	400 mg/dL	Hct: 35% PCV	-6.61%
	Magnesium Chloride	47.61 mg/dL	Hct: 55% PCV	-6.40%
	Magnesium Chloride	47.61 mg/dL	Hct: 35% PCV	-9.39%
	Potassium Chloride	59.64 mg/dL	Hct: 55% PCV	-6.27%
	Potassium Chloride	59.64 mg/dL	Hct: 35% PCV	< 6%
	Sodium Chloride	117 mg/dL	55% PCV	< 6%
	Sodium Chloride	117 mg/dL	35% PCV	-6.36%
	Bicarbonate (NaHCO3)	58.8 mg/dL	55% PCV	< 6%
	Bicarbonate (NaHCO3)	58.8 mg/dL	35% PCV	-7.72%

NOTES:

The addition of 50,000 WBC cu/mL to a blood sample with 6.1 x 10° WBC cu/mL causes an increase in Hct %PCV measured by the EDAN i15 relative to spun hematocrit %PCV by 4.43 %PCV (absolute) or 11% (relative) exceeding the Total Allowable Error defined in CLIA'88.

Hemolysis will increase the potassium measurement on i15 system due to release of potassium from the red blood cells. When the amount of hemoglobin in plasma is increased by 500 mg/dL, the increase in K+ measurement tested on i15 system is about 36%; when the amount of hemoglobin in plasma is increased by 100 mg/dL, the increase in K+ measurement tested on i15 system is about 29%.

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f. Determination of Detection Limits for ionized Calcium
Detection limits were determined by obtaining the standard deviation of sample measurements from repeated measurements of samples with a relevant low concentration. To determine LoB, zero level samples were prepared and measured on two EDAN i15 instruments with different lots of Test Cartridges and Calibrator Fluid Packs to obtain blank measurements (N=120). To determine the LoD and LoQ, whole blood samples with low levels of analyte (approximately 1 to 4 x LoB) were measured on two instruments (N=120). The LoQ was determined based on the inter-assay precision (%CV). The limit of quantitation (LoQ) is based on an accuracy goal of 0.125 mmol/L. The accuracy goal was met and therefore, the LoQ is equal to the LoD of 0.11 mmol/L. Results of the study are presented in the following table:

Measurand	LOB	LOU	LOO	Claimed Measurement Range
lonized Calcium	0.09 mmol/L 0.11 mmol/L 0.11 mmol/L			0.25 – 2.50 mmol/L

Summary of Clinical Site Testing

Studies were conducted at 4 Point-of-Care (POC) sites and 3 laboratory sites to demonstrate equivalence of performance of the EDAN i15 System in comparison to previously cleared test systems cleared for the same intended use. The POC sites included a respiratory medical care unit, two medical intensive care units, an anesthesia unit and a rapid-response (STAT) lab, and employed tested by 11 persons fulfilling the minimum requirements for education and training to perform moderately complex testing in accordance with CLIA. Of these 11 persons, 10 had no prior blood gas testing experience. All testing was performed using quality control materials or discarded blood gas specimens.

a. Imprecision/Reproducibility in Aqueous Quality Control Materials
Each clinical site used to collect method comparison data, performed analysis of quality control (Blood Gas and Electrolyte Controls, and Hematocrit Controls) at the beginning and end of each testing day. The summary of imprecision from each site is provided in the table, below and demonstrate equivalence between POC and Laboratory test sites.

	Test	N	Mean	Within-Run SD	Within-Run CV%	Between-Day SD	Between-Day CV%	Total SD	Total CV%
LEVEL 1	Average of Four Point-of-Care Test Sites
Blood Gas and Electrolyte Control	pH	80	7.135	0.006	0.08%	0.004	0.05%	0.007	0.10%
	pCO2	80	73.2	2.20	3.0%	1.32	1.8%	2.56	3.5%
	pO2	80	70.9	1.71	2.4%	1.52	2.1%	2.29	3.2%
	Na+	80	121.3	0.81	0.7%	0.63	0.5%	0.99	0.8%
	K+	80	2.23	0.02	0.9%	0.02	1.0%	0.03	1.3%
	Cl-	80	78.1	0.74	0.9%	0.30	0.4%	0.80	1.0%
	Ca++	80	1.46	0.06	4.0%	0.04	2.7%	0.07	4.5%
Hct Control	Hct	80	21.0	0.67	3.2%	0.42	2.0%	0.68	3.2%
LEVEL 1	Average of Three Laboratory Test Sites
Blood Gas and Electrolyte Control	pH	104	0.006	0.09%	0.004	0.06%	0.007	0.10%	0.006
	pCO2	104	70.4	1.76	2.5%	1.19	1.7%	2.08	2.9%
	pO2	104	72.3	2.12	2.9%	1.69	2.3%	2.41	3.3%
	Na+	104	118.1	1.12	0.9%	0.49	0.4%	1.19	1.0%
	K+	104	2.24	0.03	1.5%	0.05	2.1%	0.06	2.6%
	Cl-	104	77.3	0.71	0.9%	0.37	0.5%	0.59	0.8%
	Ca++	104	1.48	0.05	3.4%	0.04	2.9%	0.06	4.3%
Hct Control	Hct	104	20.3	0.64	3.2%	0.37	1.8%	0.69	3.4%

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Test	Days	Mean	Within-Run SD	Within-Run CV%	Between-Day SD	Between-Day CV%	Total SD	Total CV%
LEVEL 2	Average of Four Point-of-Care Test Sites
Blood Gas and Electrolyte Control	pH	80	7.399	0.006	0.07%	0.002	0.03%	0.006	0.08%
	pCO2	80	43.1	1.32	3.1%	1.01	2.3%	1.66	3.9%
	pO2	80	104.8	1.83	1.7%	1.39	1.3%	2.13	2.0%
	Na+	80	143.1	0.65	0.5%	0.76	0.5%	1.00	0.7%
	K+	80	4.63	0.04	0.9%	0.03	0.6%	0.05	1.0%
	Cl-	80	99.9	0.43	0.4%	0.40	0.4%	0.58	0.6%
	Ca++	80	1.10	0.02	2.1%	0.03	2.6%	0.04	3.3%
Hct Control	Hct	80	33.7	0.33	1.0%	0.12	0.3%	0.31	0.9%
LEVEL 2	Average of Three Laboratory Test Sites
Blood Gas and Electrolyte Control	pH	104	7.402	0.004	0.05%	0.004	0.06%	0.006	0.08%
	pCO2	104	41.0	1.76	4.3%	1.19	2.9%	2.08	5.1%
	pO2	104	104.2	1.84	1.8%	2.14	2.1%	2.82	2.7%
	Na+	104	139.1	0.76	0.5%	0.87	0.6%	1.15	0.8%
	K+	104	4.59	0.04	0.8%	0.03	0.6%	0.05	1.0%
	Cl-	104	97.61	0.71	0.7%	0.73	0.8%	0.87	0.9%
	Ca++	104	1.11	0.03	2.3%	0.03	2.7%	0.04	3.5%
Hct Control	Hct	104	33.1	0.65	2.0%	0.33	1.0%	0.63	1.9%

	Test	Days	Mean	Within-Run SD	Within-Run CV%	Between-Day SD	Between-Day CV%	Total SD	Total CV%
LEVEL 3	Average of Four Point-of-Care Test Sites
Blood Gas and Electrolyte Control	pH	80	7.583	0.006	0.08%	0.002	0.03%	0.006	0.08%
and	pCO2	80	24.7	0.69	2.8%	0.56	2.3%	0.88	3.6%
Electrolyte Control	pO2	80	146.3	1.80	1.2%	1.18	0.8%	2.05	1.4%
	Na+	80	166.0	1.43	0.9%	0.91	0.6%	1.41	0.9%
	K+	80	6.84	0.06	0.8%	0.02	0.3%	0.06	0.8%
	Cl-	80	126.6	0.70	0.6%	0.82	0.6%	1.00	0.8%
	Ca++	80	0.48	0.01	3.0%	0.01	2.3%	0.02	3.7%
Hct Control	Hct	80	47.0	0.22	0.5%	0.03	0.1%	0.22	0.5%
LEVEL 3	Average of Three Laboratory Test Sites
Blood Gas and Electrolyte Control	pH	104	7.580	0.005	0.06%	0.006	0.08%	0.008	0.10%
and	pCO2	104	24.0	0.73	3.0%	0.49	2.0%	0.88	3.7%
Electrolyte Control	pO2	104	144.9	1.89	1.3%	1.57	1.1%	2.45	1.7%
	Na+	104	162.8	1.14	0.7%	0.91	0.6%	1.39	0.9%
	K+	104	6.69	0.05	0.7%	0.04	0.7%	0.06	1.0%
	Cl-	104	123.9	1.12	0.9%	1.08	0.9%	1.41	1.1%
	Ca++	104	0.49	0.01	2.6%	0.02	3.2%	0.02	4.1%
Hct Control	Hct	104	46.9	0.61	1.3%	0.39	0.8%	0.68	1.5%

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b. Method Comparison

In seven clinical sites (four POC and three laboratory) used for the evaluation of bias on patient samples, the protocol in CLSI Document EP09-A3 Method Comparison and Bias Estimation Using Patient Samples was applied in which each sample was measured in duplicate on both the EDAN i15 and its predicate device. All testing was performed using discarded patient samples collected into either B-D Vacutainer lithium heparin tubes or B-D balanced heparin arterial sampling syringes. Four POC sites and all LAB sites utilized the RapidPoint 400 as the comparator device and are combined for presentation below. Up to 4 data pairs for a single measurand were eliminated from this method comparison because values were outside claimed measurement range.

EDAN vs Predicate
Measurand	Site	Nr.	range	claimed range	slope	intercept	std error	r-value
pH	POC 1-4	257	6.826 - 7.675		1.0130	-0.0961	0.0218	0.9909
	all LAB	228	6.531 - 7.791	6.500 - 7.800	1.0085	-0.0640	0.0208	0.9940
	all Sites	488	6.531 - 7.791	97%	1.0105	-0.0778	0.0213	0.9933
pCO2	POC 1-4	257	18.0 - 144.8		1.0285	-1.5528	3.6695	0.9841
mmHg	all LAB	226	10.9 - 144.9	10 - 150	0.9523	1.0417	3.3262	0.9916
	all Sites	483	10.9 - 144.9	96%	0.9843	0.1813	3.6383	0.9879
pO2	POC 1-4	257	17 - 585		1.0368	-4.1355	6.5734	0.9974
mmHg	all LAB	229	10 - 661	10 - 700	1.0018	0.2151	6.9117	0.9989
	all Sites	486	10 - 661	94%	1.0119	-1.0639	6.9830	0.9983
Na+	POC 1-4	257	110 - 170		0.9787	2.5631	1.6065	0.9802
mmol/L	all LAB	229	101 - 180	100 - 180	0.9909	0.8032	1.5810	0.9952
	all Sites	486	101 - 180	99%	0.9886	1.1358	1.5927	0.9923
K+	POC 1-4	257	2.4 - 9.0		0.9838	0.0250	0.0791	0.9968
mmol/L	all LAB	230	2.6 - 8.2	2.0 - 9.0	0.9868	0.0450	0.1181	0.9963
	all Sites	487	2.4 - 9.0	94%	0.9895	0.0164	0.1005	0.9968
Cl-	POC 1-4	257	77 - 137		1.0188	-2.2648	1.7342	0.9821
mmol/L	all LAB	227	66 - 139	65 - 140	1.0000	0.2599	2.0765	0.9899
	all Sites	484	66 - 139	97%	1.0012	-0.1469	1.9205	0.9875
Ca++	POC 1-4	257	0.47 - 1.82		0.9568	0.0428	0.0457	0.9695
mmol/L	all LAB	228	0.30 - 2.42	0.25 - 2.50	0.9919	0.0228	0.0416	0.9921
	all Sites	485	0.30 - 2.42	94%	0.9848	0.0200	0.0453	0.9854
Hct	POC 1-4	257	21 - 60		0.9853	0.8173	1.2295	0.9891
%	all LAB	230	13 - 72	13 - 72	0.9842	0.6787	1.0990	0.9933
	all Sites	487	13 - 72	100%	0.9827	0.8306	1.1707	0.9917

Traceability

The parameters measured and reported by the EDAN i15 Blood Gas and Chemistry Analysis System, including the Calibrant Fluid Pack are calibrated and tested for release using primary and secondary standards traceable to NIST or other recognized standards (where no NIST standard is available or practical) as summarized below:

Analyte	Traceability
pH	Buffer solution made with NIST HEPES SRM 2181 and 2182
pCO2, pO2	NIST traceable pure gases gravimetrically prepared
Na, Cl	NIST SRM 919b
K	NIST SRM 918b

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Ca	NIST SRM 915b
Hct	CLSI H7-A3 Procedure for Determining Packed Cell Volume by the Microhematocrit Method

Stability and Value Assignment for Controls and Calibrant Fluid Pack

Stability / Shelf Life:

. EDAN i15 Calibrant Fluid Pack – 12 month shelf-life when stored unopened at 2-8°C (35-46°F) (avoid freezing) and 30 days after installation on the instrument or until expiration date is reached.
. EDAN i15 Blood Gas and Electrolyte Controls - 36 months when stored at 2-8°C (35-46°F) (avoid freezing) including up to 9 months at 2-25°C (35-77°C) or until expiration date is reached.
EDAN i15 Hematocrit Controls – 24 months when stored at 2-25°C (35-77°C) or until expiration date is reached.

Value Assignment

EDAN i15 Calibrant Fluid Pack
Value assignment of the Calibrant Fluid Pack is performed by determination of measurement bias between the test lot and traceable reference standards or methods using reference instrumentation and three Calibrant Fluid Packs from the production batch. The bias for each measurand is applied to the value of the reference standard to determine the value assignment for the test lot.

Parameter	Target Value	Parameter	Target Value
pH	7.342	pO2 (mmHg)	154.0
pCO2 (mmHg)	41.3	Na+ (mmol/L)	140.0
K+ (mmol/L)	4.80	Ca++ (mmol/L)	1.22
Cl- (mmol/L)	100	Hct (%PCV)	9.5%

NOTE: These values are for example only. Actual values for each parameter are programmed in the bar code of a Calibrant Fluid Pack and may vary with the lot number of a Calibrant Fluid Pack.

● EDAN i15 Blood Gas and Electrolyte Control

Value assignment for each new lot of control solution is performed by parallel testing on existing and new lots to determine bias for each measurand. This bias is applied to the value assigned to the existing lot to determine acceptable values for the new lot. Control solution testing is integrated into final release testing for all i15 instruments to ensure consistent performance across Calibrant Fluid Pack and Test Cartridge Lots.

Blood Gas and Electrolyte Control
	Level 1	Level 2	Level 3
	Lot 41526	Lot 41625	Lot 41726
Parameter	Acceptable Range	Acceptable Range	Acceptable Range
pH	7.096 - 7.196	7.361 - 7.461	7.539 - 7.639
pCO2 (mmHg)	58.9 - 74.9	33.4 - 47.4	15.8 - 27.8
pO2 (mmHg)	59.7 - 89.7	91.5 - 125.5	126.1 - 170.1
Na+ (mmol/L)	108.5 - 118.5	126.5 - 136.5	148.0 - 158.0
K+ (mmol/L)	1.47 - 2.47	3.87 - 4.87	5.67 - 6.87
Ca++ (mmol/L)	1.32 - 1.72	1.01 - 1.31	0.47 - 0.67
Cl- (mmol/L)	68.6 - 78.6	88.1 - 100.1	112.5 - 128.5

EDAN i15 Hematocrit Control Value assignment for each new lot of control solution is performed by parallel testing on existing

{25}------------------------------------------------

and new lots to determine bias for each measurand. This bias is applied to the value assigned to the existing lot to determine acceptable values for the new lot. Control solution testing is integrated into final release testing for all i15 instruments to ensure consistent performance across Calibrant Fluid Pack and Test Cartridge Lots.

	Hematocrit Control
	Low Level	High Level
	Lot 43933	Lot 43931
Parameter	Acceptable Range	Acceptable Range
Hct, PCV%	17 - 23	43 - 51

Conclusion

The information provided in this Premarket Notification [510(k)] supports a determination of substantial equivalence for the EDAN i15 Blood Gas and Chemistry Analysis System, including the EDAN i15 Blood Gas and Chemistry Analyzer, EDAN i15 Calibrator Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, and EDAN i15 Hematocrit Control.

Regulation Number and Section

§ 862.1120 Blood gases (P

CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.