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.

Device Description

Eurotrol Hct 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

AI/ML Overview

The provided text describes a 510(k) submission for "Eurotrol Hct Control and epoc® Hematocrit Verification Fluids," which are quality control materials for hematocrit measurements. This document is a premarket notification for a medical device that verifies the precision and accuracy of another device (the epoc Blood Analysis System). It is not a diagnostic device that performs a clinical diagnosis; thus, the concepts of sensitivity, specificity, human reader performance, MRMC studies, or training/test sets for AI models as typically applied to image-based diagnostic AI devices are not applicable here.

The "acceptance criteria" and "device performance" in this context refer to the characteristics and performance of the control fluid itself in demonstrating its suitability for verifying other devices.

Here's the breakdown based on the provided text, adapted for a quality control material:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for a quality control material revolve around its ability to provide stable and accurate reference values. The "performance" is demonstrated by its inherent properties and its equivalence to a predicate device.

Characteristic	Acceptance Criteria (Implied / Comparator)	Reported Device Performance (New Device)
Number of Levels	Must have multiple levels to cover clinically significant ranges (Predicate has 5)	5 distinct Hct levels (conductivity), simulating clinically significant ranges of Hematocrit.
Analytes	Hematocrit (Conductivity)	Hematocrit (Conductivity)
Container	Suitable for stability and handling (Predicate: Clear glass ampules)	Clear glass ampules
Filling Volume	Sufficient for use (Predicate: 1.7 mL)	2.5 mL
Color	Clear, to avoid interference	Clear
Storage Temperature	Stable within a reasonable range (Predicate: 2 - 25°C/35 - 77°F)	2 - 30°C/35 - 86°F (Broader, which is an improvement)
Matrix/Materials	Stable aqueous solution without interfering substances	Prepared using pure chemicals in a physiologically buffered matrix. Aqueous buffered solution of water and electrolytes. This product contains no red cells and no human or biological materials.
Intended Use	To verify precision and accuracy of hematocrit measurement systems	To verify the precision and accuracy of the epoc® Blood Analysis System for the measurement of hematocrit.
Stability	Must maintain performance over time	12 months (Real-time evaluation of the products to support stability was conducted.)
Precision (QC fluid)	The QC fluid itself should provide consistent results	Precision testing was conducted. (Specific values for precision are not provided in the summary but were generated for the submission).
Accuracy (QC fluid)	The QC fluid should have assigned values that laboratories can use for reference	Assigned values of each batch are printed on a value sheet as available from the Epocal website (http://www.epocal.com/doc_library.html). (This demonstrates how users verify accuracy of their instrument against the QC fluid's known value.)

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

This is not applicable in the typical sense of a diagnostic device's test set for patient data. For this quality control material, the "test set" would refer to the samples of the QC fluid itself tested during its development and validation.

Test Samples: The document states "Tests were conducted to verify specific performance requirements: a) Real-time evaluation of the products to support stability. b) Test precision." The exact number of ampules or batches tested for these purposes is not specified in the summary but would have been part of the non-clinical testing data submitted to the FDA.
Data Provenance: The testing was conducted by Eurotrol B.V. in The Netherlands. This is a non-clinical, controlled laboratory setting, not patient data. It is inherently prospective testing of the manufactured QC material.

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

Not applicable. The ground truth for a quality control material is established by:

Its chemical formulation.
The highly precise and accurate methods used to assign values to each lot/batch in a reference laboratory setting (e.g., using reference methods and highly calibrated instruments).
Comparative testing against established predicate devices.

There are no "experts" in the sense of clinical reviewers establishing diagnoses as ground truth for this type of device.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or diagnostic decision-making involved that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is relevant for diagnostic devices where human reader performance is being evaluated, especially in the context of AI assistance. A quality control material does not involve human readers for diagnostic interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a fluid, not an algorithm. Its "performance" is its chemical stability and its ability to act as a reliable reference standard for an analytical instrument.

7. The Type of Ground Truth Used

The ground truth for this quality control material is its precisely manufactured and characterized chemical composition and its assigned hematocrit values, which are determined by highly accurate reference measurement procedures. This is essentially a "reference standard" or "master value" derived from rigorous chemical and metrological characterization. Its primary evidence for substantial equivalence relies on comparison to a predicate device (RNA Medical QC 900 Hematocrit Control) that is already legally marketed and accepted as a reliable standard.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI models that require training sets of data.

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

Not applicable, as there is no training set for an AI model.

Summary

{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 andepoc®Hematocrit VerificationFluids	RNA Medical QC 900 HematocritControl
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
Storagetemperature	2 - 30°C/35 - 86°F	2 - 25°C/35 - 77°F
Matrix/Materials	Eurotrol Hematocrit Control isprepared using pure chemicals in aphysiologically buffered matrix.Different concentrations provide fivedistinct Hct levels (conductivity),simulating clinically significant rangesof Hematocrit.	QC 900 is a buffered aqueous solutioncontaining electrolytes andnon-conductive ingredients. Thisproduct contains no red cells and nohuman 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.

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

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

Regulation Number and Section

§ 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.