K Number

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

Manufacturer

EDAN INSTRUMENTS, INC.

Date Cleared

2016-07-15

(364 days)

Product Code

CHL CEM CGZ GKF GLK JFP JGS JIX JJS

Regulation Number

862.1120

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K002738, K943754, K955630

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description explicitly states it is "microprocessor-based and incorporates traditional sensor technology for measurement." There is no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

No.
The device is described as an "in-vitro diagnostic use only" system that measures various blood components for diagnosis and treatment of conditions, rather than directly treating a disease or condition.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the system "is used in the diagnosis and treatment of life-threatening acid-base and/or oxygenation disturbances," and lists various measurements (e.g., Na+, K+, Cl-) that are "used in the diagnosis and treatment" of specific conditions. This clearly indicates its role in diagnostics.

SaMD (Software as a Medical Device)

The device is described as a "Blood Gas and Chemistry Analysis System" which includes a "Blood Gas and Chemistry Analyzer, Calibrant Fluid Pack, Test Cartridge". This clearly indicates the presence of hardware components beyond just software.

IVD (In Vitro Diagnostic)

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

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The system is intended for in-vitro diagnostic use only..."
Nature of Measurement: The device measures various analytes (pH, blood gases, electrolytes, hematocrit) in whole blood samples. This is a classic example of an in vitro test, as it involves analyzing a biological sample outside of the body to aid in diagnosis and treatment.
Intended Use for Diagnosis and Treatment: The indications for use clearly link the measurements to the diagnosis and treatment of various medical conditions (e.g., acid-base disturbances, electrolyte imbalances, anemia). This aligns with the definition of an IVD, which is used to provide information for diagnosis, monitoring, or treatment.
Components: The system includes components like calibrant fluid packs and quality controls, which are typical consumables for IVD systems used to ensure accurate and reliable results.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

CHL, JGS, CEM, JFP, CGZ, GKF, JIX, JJS, GLK

Device Description

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 measures pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct
BG3 measures pH, pCO2, pO2
BC4 measures 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.

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

Calculated Parameters include:

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 measured anions 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 of hemoglobin bound to oxygen to the total amount of hemoglobin able to bind oxygen
pO2 (A-a): Alveolar-arterial oxygen tension difference
pO2 (A-a) (T): Alveolar-arterial oxygen tension difference corrected for entered patient temperature
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 difference to arterial pO2
RI (T): Respiratory index: the ratio of the alveolar-arterial blood oxygen-pressure difference to 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 entered patient temperature

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained health care professionals in a laboratory environment, near patient or point-of-care settings.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

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

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.

Acceptance Criteria: slope between 0.95 and 1.05 and r-value ≥ 0.975.
Comparison: 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.
Key Results: The evaluation demonstrated equivalent, linear performance over the analytical measurement range for all measurands in samples from syringes and from glass capillary tubes.

b. Imprecision in External Controls

Study Type: Imprecision study
Sample Size: 3 levels of EDAN i15 Blood Gas and Electrolyte Control and 2 levels of EDAN i15 Hematocrit Control, run in duplicate each day for a total of 20 runs on one EDAN i15 Blood Gas and Chemistry Analysis System.
Protocol: Based on methods described in CLSI EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second edition.
Key Results: Precision data provided for pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct for all levels. Most CVs were below 5%.

c. Precision in Whole Blood
Hematocrit Venous Whole Blood Precision

Study Type: In-house within-run precision study.
Sample Size: Heparinized venous whole blood samples from eight volunteers. Six levels prepared (one per day for 6 days). Each sample run in replicates of 10 on 3 EDAN i15 analyzers, using 3 reagent lots. Total of 30 results per level.
Key Results: CVs for Hct in venous whole blood ranged from 1.2% to 6.3% for syringe samples and 1.3% to 5.9% for capillary samples.

Venous Whole Blood Precision (Multi-analyte)

Study Type: In-house precision study.
Sample Size: Venous whole blood from 3 healthy volunteers. Samples tonometered to nominal gas values for some analytes. Run in replicates of 10 on each of the three analyzers for a total of 30 results.
Key Results: Within-run precision data provided for pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct in both syringe and capillary samples. Most CVs were below 4%.

d. Comparison of Syringe and Capillary Measurement

Study Type: Comparison study.
Sample Size: Whole blood venous samples from healthy volunteers. Six levels of blood prepared and tonometered. Analyzed over numerous days on three (3) EDAN i15 instruments with 10 replicates on each of six (6) levels, for both capillary and syringe introduction.
Key Results: Correlation in whole blood samples introduced from Capillary vs Syringe showed high r-values (0.9922 to 0.9981) and small biases for all measurands, demonstrating equivalence.

e. Specificity / Interference Testing

Study Type: Interference study.
Protocol: According to CLSI guideline EP7-A2. Spiked and diluted human whole blood samples containing potential interferents. Seven replicates of both spiked and unspiked samples tested on two i15 Blood Gas and Chemistry System with one lot of test cartridges. Percent bias (absolute difference for pH) calculated.
Acceptance Criteria: Specified bias limits for each measurand (e.g., pH

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.

Summary

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right, representing health and human services.

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

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

Indications for Use

510(k) Number (if known) K151978

Device Name

EDAN i15 Blood Gas and Chemistry Analysis System

Indications for Use (Describe)

| 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.

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.

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.

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.

f 1

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."

Image /page/8/Picture/0 description: The image shows the logo for EDAN, which includes the company's name in bold, gray letters. Above the name are two leaves, one yellow and one green, symbolizing growth and nature. Below the name is the tagline "A world of potential" in a smaller, black font, suggesting the company's vision and aspirations.

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.

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) 400
Measurement Cartridge			Candidate Device:	EDAN i15 Blood Gas and Chemistry
Analysis System Calibrant Fluid Pack

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

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.

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 measured
anions 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 of
hemoglobin bound to oxygen to the total amount of hemoglobin able to bind
oxygen
pO2 (A-a)	Alveolar-arterial oxygen tension difference
pO2 (A-a) (T)	Alveolar-arterial oxygen tension difference corrected for entered patient
temperature
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 difference
to arterial pO2
RI (T)	Respiratory index: the ratio of the alveolar-arterial blood oxygen-pressure difference
to 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 entered
patient temperature

Indications for Use

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

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

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

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 of
Levels	Claimed
Measuring Range	Specimen Range	% of
claimed
range	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.

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 %

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:

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 range
tested | 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+
Evaluation
Method	Absolute
difference	Percent
Bias	Percent
bias	Percent
bias	Percent
bias	Percent
bias	Percent
bias	Percent
bias
Acceptance
Criteria	p CO2	60 mmHg	K+: 5 mmol/L	10.13%
			K+: 3 mmol/L