(36 days)
Not Found
No
The document describes calibration and verification fluids for a blood analysis system. There is no mention of AI or ML in the intended use, device description, or any other section. The device is a reference material, not a software or hardware system that would typically incorporate AI/ML.
No
The device is described as an "assayed blood gas, electrolyte and metabolite material" used to verify the precision and accuracy of a blood analysis system, not to directly treat or diagnose a patient.
No
This device is described as an "assayed blood gas, electrolyte and metabolite material" and "reference materials, to verify the precision and accuracy of the epoc® Blood Analysis System." Its purpose is to test and verify the performance of another system, not to directly diagnose medical conditions in patients.
No
The device description clearly states that the device is a physical material (assayed blood gas, electrolyte and metabolite reference materials) filled in glass ampules. It is a control material for a blood analysis system, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the materials are used "to verify the precision and accuracy of the epoc® Blood Analysis System" and "to verify calibration, operating temperature and other performance characteristics." This indicates that the device is used in vitro (outside the body) to assess the performance of another diagnostic device (the epoc system).
- Device Description: The description confirms that these are "assayed blood gas, electrolyte and metabolite reference materials." Reference materials used to verify the performance of diagnostic tests are considered IVDs.
- Analytes Tested: The list of analytes (pH, pO2, pCO2, Na+, K+, etc.) are all parameters typically measured in in vitro diagnostic tests of blood.
- Predicate Device: The mention of a predicate device (K032453; RNA Medical® Brand CVC 123 Calibration Verification Controls) which is also a calibration verification control, further supports the classification as an IVD. Calibration verification controls are a common type of IVD used in clinical laboratories.
In summary, the device is a control material used to verify the performance of an in vitro diagnostic system (the epoc Blood Analysis System) by testing specific analytes in a sample outside the body. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
JJY
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
professional use only.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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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 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
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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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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