(358 days)
No
The device is a reference material for verifying the accuracy of a hematocrit measurement system, not the system itself. The description focuses on the composition and packaging of the control fluids. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
This device is an in vitro diagnostic (IVD) reference material used to verify the precision and accuracy of a blood analysis system, not to treat a medical condition.
No
This device is a reference material used to verify the precision and accuracy of a diagnostic device (the epoc® Blood Analysis System), not a diagnostic device itself. It is for "in vitro diagnostic use only," which means it's used in the diagnostic process but not to make a diagnosis directly.
No
The device description clearly states that the device is an "assayed hematocrit reference material" and "electrolyte solutions," which are physical substances, not software.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "Eurotrol Hct Control is for in vitro diagnostic use only." and "epoc® Hematocrit Verification Fluids is for in vitro diagnostic use only."
- Purpose: The device is described as an "assayed hematocrit reference material, to verify the precision and accuracy of the epoc® Blood Analysis System for the measurement of hematocrit." This function of verifying the performance of a diagnostic system used to measure a blood parameter (hematocrit) falls squarely within the definition of an in vitro diagnostic device.
- Predicate Device: The predicate device listed, "K955630, RNA Medical QC 900 Hematocrit Control," is also a hematocrit control, which are typically classified as IVDs.
Therefore, the text strongly indicates that this device is intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
epoc® Hematocrit Verification Fluids is an assayed hematocrit reference material, to verify the precision and accuracy of the epoc® Blood Analysis System for the measurement of hematocrit.
Eurotrol Hot Control is an assayed hematocrit reference material, to verify the precision and accuracy of the epood Blood Analysis System for the measurement of hematocrit.
Eurotrol Hct Control and epoc® Hematocrit Verification Fluids are for professional use only.
Eurotrol Hct Control is an assayed hematocrit reference material, to verify the precision and accuracy of the epoc® Blood Analysis System for the measurement of hematocrit. Eurotrol Hct Control is for in vitro diagnostic use only.
epoc® Hematocrit Verification Fluids is an assayed hematocrit reference material, to verify the precision and accuracy of the epoc® Blood Analysis System for the measurement of hematocrit.
epoc® Hematocrit Verification Fluids is for in vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
GLK
Device Description
Eurotrol Het Control and epoc® Hematocrit Verification Fluids are assayed hematocrit reference materials, to verify the precision and accuracy of the epoc@ Blood Analysis System, manufactured by Epocal Inc., Ottawa, ON K1G3P5, Canada, as cleared by FDA, K061597. Eurotrol Hematocrit Control was designed to test the following analytes: Hematocrit.
Eurotrol Hot Control and epoc® Hematocrit Verification Fluids electrolyte solutions with conductivity at five levels appropriate to simulate clinically relevant hematocrit concentrations useful to evaluate the measurement of the epoc Blood Analysis System.
Depending the sales unit, 10 ampules of the same level are packed in a carton box for Eurotrol Hct Control, or 5 ampule per level, are packed in a carton box for epoc®Hematocrit Verification Fluids. A product insert with Intended Use is inserted in each product box.
The assigned values of each batch are printed on a value sheet as available from the Epocal website: http://www.epocal.com/doc_library.html
Eurotrol Hot Control and epoc@ Hematocrit Verification Fluids are filled in 3 mL clear glass ampules. Each ampule contains 2.5 mL product.
This material consists of an Aqueous buffered solution of water and electrolytes in 5 different levels.
The stability of Eurotrol Hematocrit Control is 12 months.
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
Professional use only.
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)
Summary of non-clinical tests submitted with the premarket notification for the device.
Tests were conducted to verify specific performance requirements:
a) Real-time evaluation of the products to support stability.
b) Test precision
Summary of clinical tests submitted with the premarket notification for the device.
N/A
Conclusions drawn from the clinical and non-clinical trials.
Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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).
Not Found
§ 864.8625 Hematology quality control mixture.
(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
0
K 121467
Eurotrol B.V. Eurotrol Hct Control and epoc Hematocrit Verification Fluids May 10, 2013
MAY 1 0 2013
510(k) Summary
Submitter:
Eurotrol B.V. Keplerlaan 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: May 10, 2013 Eurotrol Hct Control and epoc® Hematocrit Verification Fluids Proprietary Names: Hematocrit control, (21 CFR 864.8625, Product Code GLK) Classification Name: Common Name: Eurotrol Hematocrit Control RNA Medical QC 900 Hematocrit Control (K955630) Equivalent to:
Substantial Equivalence
Eurotrol Hematocrit Control is substantially equivalent in function, safety and efficacy to currently marketed devices produced by Bionostics.
Comparison of Eurotrol Hematocrit Control to predicate device for substantial equivalency:
| New Device | Predicate Device | |
|---|---|---|
| Eurotrol Hct Control and | ||
| epoc®Hematocrit Verification | ||
| Fluids | RNA Medical QC 900 Hematocrit | |
| Control | ||
| 510(k), date | K955630, 03/01/1996 | |
| Number of levels | 5 | 5 |
| Analytes | Hematocrit (Conductivity) | Hematocrit (Conductivity) |
| Container | Clear glass ampules | Clear glass ampules |
| Filling Volume | 2,5 mL | 1,7 mL |
| Color | Clear | Clear |
| Storage | ||
| temperature | 2 - 30°C/35 - 86°F | 2 - 25°C/35 - 77°F |
| Matrix/Materials | Eurotrol Hematocrit Control is | |
| prepared using pure chemicals in a | ||
| physiologically buffered matrix. | ||
| Different concentrations provide five | ||
| distinct Hct levels (conductivity), | ||
| simulating clinically significant ranges | ||
| of Hematocrit. | QC 900 is a buffered aqueous solution | |
| containing electrolytes and | ||
| non-conductive ingredients. This | ||
| product contains no red cells and no | ||
| human or biological materials. |
1
510(k) K121467, 510(k) Summary Eurotrol B.V. Eurotrol Hct Control and epoc Hematocrit Verification Fluids May 10, 2013
Description of the new device
Eurotrol Het Control and epoc® Hematocrit Verification Fluids are assayed hematocrit reference materials, to verify the precision and accuracy of the epoc@ Blood Analysis System, manufactured by Epocal Inc., Ottawa, ON K1G3P5, Canada, as cleared by FDA, K061597. Eurotrol Hematocrit Control was designed to test the following analytes: Hematocrit.
Eurotrol Hot Control and epoc® Hematocrit Verification Fluids electrolyte solutions with conductivity at five levels appropriate to simulate clinically relevant hematocrit concentrations useful to evaluate the measurement of the epoc Blood Analysis System.
Depending the sales unit, 10 ampules of the same level are packed in a carton box for Eurotrol Hct Control, or 5 ampule per level, are packed in a carton box for epoc®Hematocrit Verification Fluids. A product insert with Intended Use is inserted in each product box.
The assigned values of each batch are printed on a value sheet as available from the Epocal website: http://www.epocal.com/doc_library.html
Intended Use
epoc® Hematocrit Verification Fluids is an assayed hematocrit reference material, to verify the precision and accuracy of the epoc® Blood Analysis System for the measurement of hematocrit.
Eurotrol Hot Control is an assayed hematocrit reference material, to verify the precision and accuracy of the epood Blood Analysis System for the measurement of hematocrit.
Eurotrol Hct Control and epoc® Hematocrit Verification Fluids are for professional use only.
Technological Characteristics
Eurotrol Hot Control and epoc@ Hematocrit Verification Fluids are filled in 3 mL clear glass ampules. Each ampule contains 2.5 mL product.
This material consists of an Aqueous buffered solution of water and electrolytes in 5 different levels.
The stability of Eurotrol Hematocrit Control is 12 months.
Summary of non-clinical tests submitted with the premarket notification for the device.
Tests were conducted to verify specific performance requirements:
a) Real-time evaluation of the products to support stability.
b) Test precision
Summary of clinical tests submitted with the premarket notification for the device.
N/A
Conclusions drawn from the clinical and non-clinical trials.
Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
PAUL B. P. KOOIJMANS REGULATORY AFFAIRS MANAGER EUROTROL B.V. KEPLERLAAN 20 6716 BS, EDE THE NETHERLANDS
May 10. 2013
Re: K121467
Trade/Device Name: Eurotrol Het Control and epoc® Hematocrit Verification Fluids Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: II Product Code: GLK Dated: April 19, 2013 Received: April 29, 2013
Dear Mr. 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 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance 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" (21CFR 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/McdicalDevices/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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Reena Philip -S
for
Maria M. Chan Director, Division of Immunology and Hematology Devices
Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):_k121467
Device Name: Eurotrol Hct Control and epoc® Hematocrit Verification Fluids
Indications For Use:
Eurotrol Hct Control
Eurotrol Hct Control is an assayed hematocrit reference material, to verify the precision and accuracy of the epoc® Blood Analysis System for the measurement of hematocrit. Eurotrol Hct Control is for in vitro diagnostic use only.
epoc® Hematocrit Verification Fluids
epoc® Hematocrit Verification Fluids is an assayed hematocrit reference material, to verify the precision and accuracy of the epoc® Blood Analysis System for the measurement of hematocrit.
epoc® Hematocrit Verification Fluids is for in vitro diagnostic use only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH: Office of In Vitro Diagnostics and Radiological Health (OIR)
Maria M. @han -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K121467