(126 days)
Not Found
No
The device is a quality control material for hemoglobin measurement systems, not a system that processes data or makes decisions using AI/ML.
No
Explanation: The HemoTrol® WB is described as an assayed quality control material used to verify the performance of other systems (HemoCue® Hb 301 and HemoCue® Hb 801 System). It is not used for treating or diagnosing a disease or condition in a patient.
No
Explanation: The device is described as an assayed quality control material used to verify the performance characteristics of other systems (HemoCue Hb 301 and HemoCue Hb 801 System), not to diagnose a condition itself.
No
The device description clearly states that HemoTrol® WB is a physical material (liquid solution containing bovine red blood cells) packaged in bottles. It is a quality control material, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that HemoTrol® WB is an "assayed quality control material for professional use to verify the performance characteristics of the HemoCue ® Hb 301 and the HemoCue ® Hb 801 System." Quality control materials used to verify the performance of diagnostic systems are considered IVDs.
- Device Description: The description further clarifies that it's an "assayed hemoglobin quality control material intended for professional use in the verification of the precision and accuracy of the HemoCue® 301 and HemoCue® 801 systems." This reinforces its role in ensuring the reliability of diagnostic testing.
- Predicate Device: The mention of a predicate device (K964052; Eurotrol HemoTrol) which is also a quality control material for hemoglobin testing, strongly suggests that this type of product is classified as an IVD.
While the device itself doesn't directly diagnose a condition, its function is to ensure the accuracy and reliability of diagnostic devices (the HemoCue systems) that do perform in vitro diagnostic testing (quantitative determination of hemoglobin). Therefore, it falls under the definition of an IVD.
N/A
Intended Use / Indications for Use
HemoTrol® WB is an assayed quality control material for professional use to verify the performance characteristics of the HemoCue ® Hb 301 and the HemoCue ® Hb 801 System. HemoTrol® WB is intended for the quantitative determination of hemoglobin.
Product codes
GGM
Device Description
HemoTrol® WB is an assayed hemoglobin quality control material intended for professional use in the verification of the precision and accuracy of the HemoCue® 301 and HemoCue® 801 systems. HemoTrol® WB contains bovine red blood cells with hemoglobin lysates in MetHb and additional stabilizers. For daily quality control, three physiological relevant levels are available.
HemoTrol® WB solutions are filled in reclosable plastic primary containers. Each bottle contains 1.1 g of HemoTrol® WB solution. The primary containers are equipped with colored polypropylene caps. Cap color depends on the concentration of hemoglobin (Low: red cap; High: blue cap). Two (2) bottles of the same level are placed in a plastic blister and packed in a product box together with the combined instructions for use (IFU) and value sheet. Both the primary containers and product box are labeled.
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 / POC and laboratory
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
Open Stability:
According to the guidelines described in "CLSI-EP25A-2009" at least on batch of a quality control was monitored to determine the in-use stability. One batch of each level was monitored at four (4) time points (n=6) for in total 35 days at 2-8ºC. Based on this study, HemoTrol® WB is stable for 31 days when stored at 2-8ºC.
Closed Stability:
According to guidelines in "CLSI-EP25A-2009" at least 3 batches of a quality control were monitored to determine the shelf life. Three (3) batches of the three HemoTro® WB levels were monitored at 8 time points for up to 127 days (n=8) at 2-8℃. The samples used were produced according the regular production process of HemoTrol® WB. The total hemoglobin levels were measured on the HemoCue® Hb 301 and HemoCue® Hb 801 systems. Based on this study, HemoTrol® WB is stable for 108 days when stored at 2-8ºC.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 1, 2019
Eurotrol B.V. Mylene de Boer QA/RA Officer Keplerlaan 20 Ede, Gelderland, 6716BS, NL
Re: K182744
Trade/Device Name: HemoTrol WB - Low, HemoTrol WB - Normal and HemoTrol WB - High Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: GGM Dated: September 26, 2018 Received: September 28, 2018
Dear Mylene de Boer:
We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Leonthena R. Carrington -S
Lea Carrington 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) K182744
Device Name
HemoTrol® WB - Low, HemoTrol® WB - Normal and HemoTrol® WB - High
Indications for Use (Describe)
HemoTrol® WB is an assayed quality control material for professional use to verify the performance characteristics of the HemoCue ® Hb 301 and the HemoCue ® Hb 801 System. HemoTrol® WB is intended for the quantitative determination of hemoglobin.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image contains the word "Confidential" in a light gray color. The word is slanted diagonally across the image. The background is a plain white color.
Image /page/3/Picture/1 description: The image shows the Eurotrol logo. The logo consists of a red circle with a white center, surrounded by two gray ovals. Below the logo is the word "Eurotrol" in a bold, sans-serif font. Below the word "Eurotrol" is the phrase "Your Global Reference Point for Quality Control" in a smaller, sans-serif font.
510(K) Summary HemoTrol WB
September 2018
This summary of the 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.
Submitter
Eurotrol B.V.
Keplerlaan 20
6716 BS, Ede, the Netherlands
T: +31 318 695777
Primary Contact: Ms. Mylène de Boer, mdeboer@eurotrol.com
Device Information
| Device name | REF |
|---|---|
| HemoTrol® WB – Low | 08718734960942 |
| HemoTrol® WB – Normal | 08718734960959 |
| HemoTrol® WB – High | 08718734960966 |
Classification
Class II (21 CFR 864,8625) GGM - control, Hemoglobin
Predicate Device
Eurotrol HemoTrol
510(k) number: K964052
Device Description
HemoTrol® WB is an assayed hemoglobin quality control material intended for professional use in the verification of the precision and accuracy of the HemoCue® 301 and HemoCue® 801 systems. HemoTrol® WB contains bovine red blood cells with hemoglobin lysates in MetHb and additional stabilizers. For daily quality control, three physiological relevant levels are available.
HemoTrol® WB solutions are filled in reclosable plastic primary containers. Each bottle contains 1.1 g of HemoTrol® WB solution. The primary containers are equipped with colored polypropylene caps. Cap color depends on the concentration of hemoglobin (Low: red cap; High: blue cap). Two (2) bottles of the same level are placed in a plastic blister and packed in a product box together with the combined instructions for use (IFU) and value sheet. Both the primary containers and product box are labeled.
4
Image /page/4/Picture/0 description: The image shows the Eurotrol logo. The logo consists of a red circle with a white center, surrounded by two gray ovals. Below the logo is the word "Eurotrol" in a bold, sans-serif font. Below the word "Eurotrol" is the phrase "Your Global Reference Point for Quality Control" in a smaller, sans-serif font.
Intended Use
New Device
Confidential
HemoTrol® WB is an assayed quality control material for professional use to verify the performance characteristics of the HemoCue ® Hb 301 and the HemoCue ® Hb 801 System. HemoTrol® WB is intended for the quantitative determination of hemoglobin.
Predicate Device
Eurotrol HemoTrol is an assayed hemoglobin control intended for professional use in the verification of the precision and accuracy of the HemoCue® B-Hemoglobin and the HemoCue Hb 201 systems.
The indication for use for HemoTrol® WB is not identical to the predicate device; however, the differences do not alter the intended diagnostic use of the device, nor do they affect the safety or effectiveness of the device compared to the predicate device. Both Hemotro® WB and the predicate device are assayed quality control materials for professional use to verify the performance characteristics of a hemoglobin analyzer but are designed for a different hemoglobin analyzer.
| Parameter | Similarities | Differences |
|---|---|---|
| Analyte | Hemoglobin | None |
| Analyte Concentration | Both devices cover the range of 95-160 g/L | Predicate device also includes: |
| 80-94 g/L | ||
| Color of liquid | Bloodlike | None |
| Contents | Purified bovine hemolisate and preservatives. | Predicate device does not |
| contain stabilized red blood cells | ||
| Filling volume | 1 ml | None |
| Intended Use | Quality Control material for | |
| professional use to verify the | ||
| performance characteristics of a | ||
| specific Hemoglobin analyzer. | Different target Hemoglobin | |
| analyzer | ||
| Number of Levels | 3 levels: Low, Normal, High | None |
| Open vail stability | 31 days | None |
| Primary Container | Reclosable plastic primary containers | |
| with polypropylene caps | None | |
| Principle of Operations | The absorbance is measured by using | |
| a dual wavelength spectrophotometric | ||
| technology. | Measurements are performed at | |
| 506 nm and 880 nm. Predicate | ||
| device at 570 nm and 880 nm. | ||
| Procedure | Allow the vial to stand for 15 minutes at | |
| room temperature | ||
| Mix the vial before sampling. | ||
| Do not fill the cuvette from the vial. | ||
| Dispense a drop of the control material | ||
| onto a hydrophobic surface. | ||
| Fill the cuvette according to the | ||
| manufacturer's instructions. | ||
| Wipe any excess material from the vial | ||
| and the cap with a clean tissue. | ||
| Recap the vial tightly. | None |
Predicate Device Comparison
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Image /page/5/Picture/0 description: The image contains the Eurotrol logo. The logo consists of a red circle with a white center, surrounded by two gray ovals. Below the logo is the word "Eurotrol" in a serif font. The logo is simple and modern, and the colors are eye-catching.
Your Global Reference Point for Quality Control
| Parameter | Similarities | Differences |
|---|---|---|
| Secondary Packaging | Two (2) bottles of the same level are | |
| placed in a plastic blister and packed in | ||
| a product box together with the | ||
| combined instructions for use (IFU) | ||
| and value sheet. | None | |
| Storage temperature | 2 - 8 degrees Celsius | None |
| Where used | POC and laboratory | None |
Performance Data
Open Stability:
onfidential
According to the guidelines described in "CLSI-EP25A-2009" at least on batch of a quality control was monitored to determine the in-use stability. One batch of each level was monitored at four (4) time points (n=6) for in total 35 days at 2-8ºC. Based on this study, HemoTrol® WB is stable for 31 days when stored at 2-8ºC.
Closed Stability:
According to guidelines in "CLSI-EP25A-2009" at least 3 batches of a quality control were monitored to determine the shelf life. Three (3) batches of the three HemoTro® WB levels were monitored at 8 time points for up to 127 days (n=8) at 2-8℃. The samples used were produced according the regular production process of HemoTrol® WB. The total hemoglobin levels were measured on the HemoCue® Hb 301 and HemoCue® Hb 801 systems. Based on this study, HemoTrol® WB is stable for 108 days when stored at 2-8ºC.
Conclusion
Based on the demonstrated intended use, performance characteristics and comparison of technical characteristics HemoTrol® WB is deemed substantially equivalent to the predicate device: Eurotrol HemoTrol (K964052)