Eurotrol GAS-ISE Metabolites is an assayed blood gas, electrolyte and metabolite material, to verify the precision and accuracy of the epoc® Blood Analysis System. Eurotrol GAS-ISE Metabolites was designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca++, Mg++, Cl-, Glucose, Lactate, Urea, Creatinine and tCO2. Eurotrol GAS-ISE Metabolites is also developed to verify calibration, operating temperature and other performance characteristics.

epoc Calibration Verification Fluids

epoc Calibration Verification Fluids is an assayed blood gas, electrolyte and metabolite material, to verify the precision and accuracy of the epoc® Blood Analysis System.

epoc Calibration Verification Fluids was designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca++, Mg++, Cl-, Glucose, Lactate, Urea, Creatinine and tCO2. epoc Calibration Verification Fluids is also developed to verify calibration, operating temperature and other performance characteristics.

Device Description

Eurotrol GAS-ISE Metabolites and epoc Calibration Fluids are assayed blood gas, electrolyte and metabolite reference materials, to venify the precision and accuracy of the epoc@ Blood Analysis System. Eurotrol GAS-ISE Metabolites and epoc Calibration Verification Fluids are filled in 3 mL clear glass ampules.

Eurotrol GAS-ISE Metabolites provides three different physiologically relevant levels. epoc Calibration Verification Fluids provides five different physiologically relevant levels.

10 ampules of the same level of Eurotrol GAS-ISE Metabolites are packed in a carton box. 5 ampules, 1 ampule per level, of epoc Calibration Fluids are packed in a carton box. A product insert with Intended Use is inserted in each product box of GAS-ISE Metabolites and epoc Calibration Verification Fluids.

AI/ML Overview

The provided 510(k) summary for Eurotrol B.V. GAS-ISE Metabolites and epoc Calibration Verification Fluids does not include detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the manner typically seen for diagnostic algorithms. Instead, it focuses on substantial equivalence to a predicate device and the traceability of its reference materials.

Here's an breakdown of the information that is available and a note on what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria or device performance in quantifiable metrics (e.g., sensitivity, specificity, accuracy, precision ranges for device vs. ground truth). Instead, it describes the intended use of the devices as "to verify the precision and accuracy of the epoc® Blood Analysis System" by providing assayed blood gas, electrolyte, and metabolite material.

The performance described is primarily related to the traceability of the analytes to recognized reference materials, which serves as an indirect form of performance validation for calibration verification fluids.

Analyte	Reference Material
pH	NIST SRM: 186 I/II, 185, 187, 191 and 192
pCO2	NIST SRM: 1674b, 2625a, 2658a and 2659a
pO2	NIST SRM: 1674b, 2625a, 2658a and 2659a
Na+	NIST SRM 956b
K+	NIST SRM 956b
Ca++	NIST SRM 956b
Cl-	NIST SRM 956b
Glucose	NIST SRM 965c
Lactate	Biomed DuoCal Multi 10260
Urea	Precipath U plus 159955 + Precinorm U plus 157249
Creatinine	NIST SRM 967a

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of evaluating an AI or diagnostic algorithm's performance on patient data. These devices are calibration verification fluids. For value assignment, the document states: "Multiple replicates of test samples are measured at the beginning and end of the production run on various analyzers for metabolites and on blood gas analyzers for blood gas and pH values." It also mentions "randomly selected samples from each lot."

Sample Size: Not explicitly stated as a number of "samples" or "replicates" for verification, but implies multiple measurements for "value assignment."
Data Provenance: Not applicable in the context of patient data. The provenance for the reference materials is stated as NIST (National Institute of Standards and Technology) and specific commercial products (Biomed DuoCal, Precipath U plus, Precinorm U plus). The study involves manufacturing and testing of the control fluids themselves.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. The "ground truth" for these calibration fluids is established through traceability to certified reference materials (NIST SRMs), not by human expert consensus on clinical data. The value assignment process involves analytical measurements.

4. Adjudication Method for the Test Set

Not applicable, as this is not a diagnostic algorithm evaluated on clinical cases requiring expert adjudication. The "value assignment" is based on instrumental measurements and takes the "mean of multiple determinations."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not done. These are calibration materials, not an AI or diagnostic device that assists human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable as the device is a control material, not an algorithm. Its performance is intrinsic to its chemical composition and its ability to provide stable, accurate values when measured by an analytical system.

7. The Type of Ground Truth Used

The ground truth for the analytes in the Eurotrol GAS-ISE Metabolites and epoc Calibration Verification Fluids is established through traceability to internationally recognized and certified reference materials (e.g., NIST Standard Reference Materials) and other commercial reference materials. This ensures the accuracy of the assigned values.

8. The Sample Size for the Training Set

Not applicable. These are calibration materials, not an AI algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no "training set" in the context of this device. The ground truth for the product's assigned values is established through metrological traceability to reference standards (as listed under point 1).

Summary

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K121468

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JUN 2 2 2012

510(k) summary of Premarket Notification K121468 Eurotrol B.V. GAS-ISE Metabolites and epoc Calibration Verification Fluids June 20, 2012

510(k) Summary

Submitter:

Eurotrol B.V. Kepleriaan 20 6716 BS Ede. The Netherlands +31 318 695777 (Telephone) +31 318 695770 (FAX)

Contact:

Paul B.P. Kooijmans (Official Correspondent) Eurotrol B.V. Keplerlaan 20 6716 BS Ede, The Netherlands +31 318 695777 (Telephone) +31 318 695770 (FAX) pkooijmans@eurotrol.com

Date of Preparation:	June 13, 2012
Proprietary Name:	Eurotrol GAS-ISE metabolites or epoc Calibration VerificationFluids
Classification Name:	Multi-analyte controls, all kinds (assayed) (21 CFR 862.1660,Product Code JJY)
Common Name:	Blood gas, electrolyte and metabolite control

Intended Use

Eurotrol GAS-ISE Metabolites

Eurotrol GAS-ISE Metabolites is an assayed blood gas, electrolyte and metabolite material, to verify the precision and accuracy of the epoo@ Blood Analysis System. Eurotrol GAS-ISE Metabolites was designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea, Creatinine and tCO2. Eurotrol GAS-ISE Metabolites is also developed to verify calibration, operating temperature and other performance characteristics. Eurotrol GAS-ISE Metabolites is for professional use only.

- epoc Calibration Verification Fluids

epoc Calibration Verification Fluids is an assayed blood gas, electrolyte and metabolite material, to verify the precision and accuracy of the epoc® Blood Analysis System. epoc Calibration Verification Fluids was designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea, Creatinine and tCO2. epoc Calibration Venfication Fluids is also developed to verify calibration, operating temperature and other performance characteristics, epoc Calibration Fluids is for professional use only.

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510(k) summary of Premarket Notification K121468 Eurotrol B.V. GAS-ISE Metabolites and epoc Calibration Verification Fluids June 20, 2012

Substantial Equivalence

Eurotrol GAS-ISE metabolites and epoc Calibration Fluids are substantially equivalent in function, safety and efficacy to the currently marketed device RNA Medical® Brand CVC 123 Calibration Verification Controls, as produced by Bionostics Inc.

Comparison of Eurotrol GAS-ISE metabolites and epoc Calibration Verification Fluids to predicate devices for substantial equivalency:

	Device	Predicate Device
	- Eurotrol GAS-ISE Metabolites	RNA Medical® Brand CVC 123
	- epoc Calibration VerificationFluids	Calibration Verification Controls
510(k), date	K121468	K032453
Number oflevels	- Eurotrol GAS-ISE Metabolites: 3- epoc Calibration Verification Fluids: 5	5
Analytes	pH, pO2, pCO2, Na+, K+, Ca++, Cl-,Glucose, Lactate, BUN, Creatinine,Mg++	pH, pO2, pCO2, Na+, K+, Ca++, Cl-,Glucose, Lactate, Mg++.
Container	Clear glass ampules	Clear glass ampules
Filling Volume	2,5 mL	2,5 mL
Color	Clear	Clear
Storagetemperature	2 - 8°C/35 - 46°F	2 - 8°C/35 - 46°F
Indications forUse	Eurotrol GAS-ISE Metabolites is anassayed blood gas, electrolyte andmetabolite material, to verify theprecision and accuracy of the epoc®Blood Analysis System.Eurotrol GAS-ISE Metabolites wasdesigned to test the following analytes:pH, pO2, pCO2, Na+, K+, Ca++, Mg++, Cl-, Glucose, Lactate, Urea,Creatinine and tCO2. Eurotrol GAS-ISE Metabolites is also developed toverify calibration, operatingtemperature and other performancecharacteristics.epoc Calibration Verification Fluids isan assayed blood gas, electrolyte andmetabolite material, to verify theprecision and accuracy of the epoc®Blood Analysis System.epoc Calibration Verification Fluidswas designed to test the followinganalytes: pH, pO2, pCO2, Na+, K+,Ca++, Mg++, Cl-, Glucose, Lactate,Urea, Creatinine and tCO2. epocCalibration Verification Fluids is alsodeveloped to verify calibration,operating temperature and otherperformance characteristics.	Confirming the calibration and linearityof bloodgas, electrolyte, and metaboliteinstrumentation for the analytes andanalyzers listed on the ExpectedValues Chart, incl. the epoc® BloodAnalysis System.

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510(k) summary of Premarket Notification K121468 Eurotrol B.V. GAS-ISE Metabolites and epoc Calibration Verification Fluids June 20, 2012

	Device	Predicate Device
	- Eurotrol GAS-ISE Metabolites- epoc Calibration VerificationFluids	RNA Medical® Brand CVC 123Calibration Verification Controls
Matrix/Materials	Salts in a physiologically buffered aqueous matrix.	Buffered aqueous solution containingelectrolytes, glucose, and lactate. Ithas been equilibrated with specificlevels of CO2, O2, and N2.
Form	Liquid	Liquid
Open Vial	30 seconds after opening the ampule	Immediate introduction to the analyzer
Stability
Values	Lot specific	Lot specific
Shelf life	12 months at 2-8°C	36 months at 2-8°C9 months at 8-25°C

Table 1. Comparison with predicate.

Device Description

Eurotrol GAS-ISE Metabolites provides three different physiologically relevant levels. epoc Calibration Verification Fluids provides five different physiologically relevant levels.

Special Instruments Required

For an appropriate use of Eurotrol GAS-ISE Metabolites and epoc Calibration Verification Fluids the use of epoc Blood Analysis System including BGE/BGEM test cards is required.

Traceability

The different levels of Eurotrol GAS-ISE Metabolites and epoc Calibration Verfication Fluids are traceable to the reference materials as shown in the table below.

Analyte	Reference Material
pH	NIST SRM: 186 I/II, 185, 187, 191 and 192
pCO2	NIST SRM: 1674b, 2625a, 2658a and 2659a
pO2	NIST SRM: 1674b, 2625a, 2658a and 2659a
Na+	NIST SRM 956b
K+	NIST SRM 956b
Ca++	NIST SRM 956b
Cl-	NIST SRM 956b

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510(k) summary of Premarket Notification K121468 Eurotrol B.V. GAS-ISE Metabolites and epoc Calibration Verification Fluids June 20, 2012

Analyte	Reference Material
Glucose	NIST SRM 965c
Lactate	Biomed DuoCal Multi 10260
Urea	Precipath U plus 159955 + Precinorm U plus 157249
Creatinine	NIST SRM 967a

Table 2. Tracebalility of the analytes of Eurotrol GAS-ISE Metabolites and epoc Calibration Fluids to reference materials.

Value assignment

Multiple replicates of test samples are measured at the beginning and end of the production run on various analyzers for metabolites and on blood gas analyzers for blood gas and pH values.

Values are assigned on the epoc® system using BGEM cards for metabolites, blood gas and pH values. Values are determined by taking the mean of multiple determinations performed on randomly selected samples from each lot. Ranges are assigned using predetermined intervals. Value assignment is performed for each lot of Eurotrol GAS-ISE Metabolites and epoc Calibration Verification Fluids.

Stability

Real time stability was performed for the Eurotrol GAS-ISE metabolites or epoc Calibration Ventication. The claimed stability is 12 months at 2-8°C or 1 week at room temperature for unopened ampule and 30 seconds for open ampules.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. To the left of the bird symbol is text arranged in a circular pattern that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

JUN 2 2 2 2012

10903 New Hampshire Avenue Silver Spring, MD 20993

Eurotrol B.V. c/o Paul B.P. Kooijmans P.O. Box 722 6710 BS, Ede The Netherlands

Re: K121468 Eurotrol GAS-ISE Metabolites; epoc Calibration Verification Fluids Trade/Device Name: Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material Regulatory Class: Class I, reserved Product Code: JJY Dated: May 16, 2012 Received: May 17, 2012

Dear Ms. Kooijmans:

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 arior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be fray be out in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r toase of advisod that I Dr. Intraination 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 with and her ree or of canalis, and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance...

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety

Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): K121468

Device Name: Eurotrol GAS-ISE Metabolites and epoc Calibration Verification Fluids

Indications for Use:

Eurotrol GAS-ISE Metabolites

epoc Calibration Verification Fluids

epoc Calibration Verification Fluids is an assayed blood gas, electrolyte and metabolite material, to verify the precision and accuracy of the epoc® Blood Analysis System.

Prescription Use X (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Q ch

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K121468

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.