Who is the manufacturer of EUROTROL GAS-ISE METABOLITES?

Eurotrol B.V. filed the 510(k) submission for EUROTROL GAS-ISE METABOLITES (K121468).

What is the FDA product code for EUROTROL GAS-ISE METABOLITES?

JJY. It is classified under 21 CFR 862.1660 as a Class 1 device in the Clinical Chemistry panel.

What is the regulatory pathway for EUROTROL GAS-ISE METABOLITES?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like EUROTROL GAS-ISE METABOLITES?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

EUROTROL GAS-ISE METABOLITES

K121468 · Eurotrol B.V. · JJY · Jun 22, 2012 · Clinical Chemistry

Device Facts

Record ID	K121468
Device Name	EUROTROL GAS-ISE METABOLITES
Applicant	Eurotrol B.V.
Product Code	JJY · Clinical Chemistry
Decision Date	Jun 22, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1660
Device Class	Class 1

Intended Use

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++, 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 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 Verification Fluids is also developed to verify calibration, operating temperature and other performance characteristics, epoc Calibration Fluids is for professional use only.

Device Story

Assayed liquid control material; used to verify precision, accuracy, and calibration of epoc Blood Analysis System. Input: physiologically buffered aqueous matrix containing salts, electrolytes, glucose, and lactate; equilibrated with CO2, O2, and N2. Output: reference values for pH, blood gases, electrolytes, and metabolites. Used in clinical settings by professionals. Healthcare providers compare measured analyzer results against assigned lot-specific values to ensure system performance and reliability. Benefits patient by ensuring accuracy of diagnostic blood analysis.

Clinical Evidence

Bench testing only. No clinical data provided. Value assignment performed via multiple replicates on epoc system using BGEM cards; traceability established against NIST SRM reference materials.

Technological Characteristics

Liquid control material in 3 mL clear glass ampules. Matrix: salts in physiologically buffered aqueous solution. Traceable to NIST SRM 186, 1674b, 956b, 965c, 967a. Stability: 12 months at 2-8°C unopened; 30 seconds after opening. No software or electronic components.

Indications for Use

Indicated for professional use to verify precision, accuracy, calibration, and operating temperature of the epoc Blood Analysis System for analytes including pH, pO2, pCO2, Na+, K+, Ca++, Mg++, Cl-, Glucose, Lactate, Urea, Creatinine, and tCO2.

Regulatory Classification

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.

Related Devices

K980135 — QUALICHECK5+ MODELS S7730, S7740, S7750, S7760 · Radiometer America, Inc. · Jan 28, 1998
K033063 — MISSION CONTROLS · Diamond Diagnostics, Inc. · Dec 12, 2003
K022529 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669 · Bio-Rad · Aug 15, 2002
K972868 — TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL · Bionostics, Inc. · Aug 28, 1997

Submission Summary (Full Text)

{0}------------------------------------------------ K121468 11 8 14 # 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 Verification Fluids | | 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. {1}------------------------------------------------ 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 Verification Fluids | Calibration Verification Controls | | | 510(k), date | K121468 | K032453 | | | Number of levels | - 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 | | | Storage temperature | 2 - 8°C/35 - 46°F | 2 - 8°C/35 - 46°F | | | Indications for Use | 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 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. | Confirming the calibration and linearity of blood gas, electrolyte, and metabolite instrumentation for the analytes and analyzers listed on the Expected Values Chart, incl. the epoc® Blood Analysis System. | | :・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ {2}------------------------------------------------ 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 Verification Fluids | RNA Medical® Brand CVC 123 Calibration Verification Controls | | Matrix/Materials | Salts in a physiologically buffered aqueous matrix. | Buffered aqueous solution containing electrolytes, glucose, and lactate. It has been equilibrated with specific levels 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°C 9 months at 8-25°C | Table 1. Comparison with predicate. ### 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. #### 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 | Page 3 of 4 {3}------------------------------------------------ 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. "台湾 : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : {4}------------------------------------------------ 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). {5}------------------------------------------------ # 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, V. 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 {6}------------------------------------------------ ## 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 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. 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