EUROTROL HEMATOCRIT CONTROL

K121467 · Eurotrol B.V. · GLK · May 10, 2013 · Hematology

Device Facts

• Record ID: K121467
• Device Name: EUROTROL HEMATOCRIT CONTROL
• Applicant: Eurotrol B.V.
• Product Code: GLK · Hematology
• Decision Date: May 10, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

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 Story

Eurotrol Hct Control and epoc® Hematocrit Verification Fluids are electrolyte solutions used as quality control materials for the epoc® Blood Analysis System. These fluids simulate clinically relevant hematocrit concentrations via conductivity measurements. The device is used by healthcare professionals to verify the precision and accuracy of the epoc® system's hematocrit channel. The fluids are provided in 2.5 mL glass ampules at multiple concentration levels. The healthcare provider introduces the fluid into the epoc® system; the system measures conductivity and converts it to a hematocrit percentage. This verification process ensures the reliability of patient hematocrit results, supporting clinical decision-making regarding patient blood status.

Clinical Evidence

No clinical data. Bench testing only. Precision/reproducibility studies were conducted across multiple sites and epoc® systems using 3 lots of control material over 20 days. Total variance (CV%) ranged from 1.89% to 4.95% across five levels, meeting the acceptance criterion of ≤9.0% CV. Stability was validated for 3 months (closed-vial) and 15 minutes (open-ampule) using measurand drift analysis.

Technological Characteristics

Electrolyte solutions in a physiologically buffered matrix; no red cells or biological materials. Conductivity-based sensing principle. Dimensions: 2.5 mL glass ampules. Storage: 15-30°C. Connectivity: None (manual sample introduction). Sterilization: Not specified. Software: None (device is a chemical reference material).

Indications for Use

Indicated for use as an assayed hematocrit reference material to verify the precision and accuracy of the epoc® Blood Analysis System for the measurement of hematocrit in a clinical setting. For prescription use only.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• RNA Medical QC 900 Hematocrit Control (k955630)

Submission Summary (Full Text)

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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 [phone] (Telephone) [phone] (FAX)

Contact:

Paul B.P. Kooijmans (Official Correspondent) Eurotrol B.V. Keplerlaan 20 6716 BS Ede, The Netherlands [phone] (Telephone) [phone] (FAX) [e-mail]

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<br>epoc®Hematocrit Verification<br>Fluids | RNA Medical QC 900 Hematocrit<br>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<br>temperature | 2 - 30°C/35 - 86°F | 2 - 25°C/35 - 77°F |
| Matrix/Materials | Eurotrol Hematocrit Control is<br>prepared using pure chemicals in a<br>physiologically buffered matrix.<br>Different concentrations provide five<br>distinct Hct levels (conductivity),<br>simulating clinically significant ranges<br>of Hematocrit. | QC 900 is a buffered aqueous solution<br>containing electrolytes and<br>non-conductive ingredients. This<br>product contains no red cells and no<br>human or biological materials. |

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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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## 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