(43 days)
Not Found
No
The device is a quality control material, not an active diagnostic or analytical system. The description focuses on the chemical composition and stability of the control solution.
No.
The device is described as an "assayed quality control material" intended to "verify the performance characteristics" of other systems, not to treat a medical condition.
No
Explanation: This device is a quality control material intended to verify the performance of other diagnostic systems (HemoCue® Hb 301 and HemoCue® Hb 801 System), not to directly diagnose a patient's condition.
No
The device is a quality control material, which is a physical substance (liquid solution) used to verify the performance of other medical devices (hemoglobin analyzers). It is not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that HemoTrol® Duo 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." This indicates it's used in vitro (outside the body) to assess the performance of diagnostic devices.
- Device Description: The description further clarifies that it's an "assayed hemoglobin quality control material intended for professional use in the verification of the performance characteristics" of the specified systems. It contains biological material (stroma-free bovine hemolysate) and is used to check the accuracy and reliability of the diagnostic instruments.
- Function: Quality control materials like HemoTrol® Duo are essential components of the IVD process. They are used to ensure that the diagnostic tests being performed are producing accurate results.
Therefore, based on its intended use and function as a quality control material for diagnostic systems, HemoTrol® Duo clearly falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HemoTrol® Duo 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® Duo is intended for the quantitative determination of hemoglobin.
Product codes (comma separated list FDA assigned to the subject device)
GGM
Device Description
HemoTrol® Duo is an assayed hemoglobin quality control material intended for professional use in the verification of the performance characteristics of the HemoCue® 301 and HemoCue® 801 systems. HemoTrol® Duo contains stroma-free bovine hemolysate with hemoglobin in cyanmethemoglobin (CNMetHb) form and a bioburden-controlling agent. For daily quality control, three physiological relevant levels are available.
HemoTrol® Duo solutions are filled in reclosable plastic primary containers. Each bottle contains 1.0 ml of HemoTrol® Duo 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
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision/Reproducibility:
Three batches of control material of each of the levels was tested on both analyzers - HemoCue Hb 301 System and HemoCue Hb 801 System. The samples were tested with five replicates per day over five operating days on 3 sites. Total precision was within the defined acceptance criteria.
HemoCue Hb301 System
Low: Mean (g/L) 70.2, SD (g/L) 2.0, CV (%) 2.9
Normal: Mean (g/L) 129.8, SD (g/L) 3.2, CV (%) 2.4
High: Mean (g/L) 168.6, SD (g/L) 3.8, CV (%) 2.2
HemoCue Hb801 System
Low: Mean (g/L) 65.0, SD (g/L) 1.1, CV (%) 1.7
Normal: Mean (g/L) 117.0, SD (g/L) 1.5, CV (%) 1.2
High: Mean (g/L) 154.5, SD (g/L) 1.6, CV (%) 1.0
Open Stability:
Nine (9) batches were monitored to determine the in-use stability. Three (3) batches of each level were monitored at three (3) time points for a total of 34 days at 30°C. Based on this study, HemoTrol Duo is stable for 31 days when stored at 30℃.
Closed Stability:
21 batches of a quality control were monitored to determine the shelf life. Three (3) batches of the three HemoTrol Duo levels (9 in total) were monitored up to 337 days at 2-8°C. The samples used were produced according the regular process of HemoTrol Duo. The total hemoglobin levels were measured on the HemoCue® Hb 301 and HemoCue® Hb 801 systems. Based on this study, HemoTrol Duo is stable for 336 days when stored at 2-8ºC.
Expected values and Value Assignment:
For batch acceptance three samples of control materials are evaluated on three HemoCue Hb301 Systems, with three batches of microcuvettes. Each sample is measured once per microcuvette batch, providing 27 replicates per analyzer. If mean value of the 27 measurements performed on the HemoCue Hb301 System is between the 'target acceptance range' the batch can be released for value assignment.
Production acceptance range on Hb301 (g/L):
Low: 70.0 ± 2.5
Normal: 130.0 ± 2.5
High: 170.0 ± 2.5
When the batch is released for value assignment the three samples of control materials are also evaluated on three HemoCue Hb801 Systems, with three batches of microcuvettes. An assigned value is subsequently determined based on each set of 27 measurements and is thus batch and analyzer specific. To determine the assigned value and range the mean value of the 27 measurements is combined with a fixed range:
Label range (g/L):
Low: Measured mean ± 12
Normal: Measured mean ± 21
High: Measured mean ± 27
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.
Not Found
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.
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Image /page/0/Picture/0 description: The image shows 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
November 15, 2019
Eurotrol B.V. Elisanne Biemans QA/RA Manager Keplerlaan 20 EDE, Gelderland, 6716BS NL
Re: K192842
Trade/Device Name: HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: GGM Dated: September 30, 2019 Received: October 3, 2019
Dear Elisanne Biemans:
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. 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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) K192842
Device Name HemoTrol® Duo Low, HemoTrol® Duo Normal and HemoTrol® Duo High
Indications for Use (Describe)
HemoTrol® Duo 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® Duo 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 shows the Eurotrol logo. The logo consists of a red circle inside a gray oval shape, with the word "Eurotrol" written in bold black letters below it. Underneath the word "Eurotrol" is the text "Your Global Reference Point for Quality Control" in a smaller font size.
510(K) Summary
HemoTrol Duo
30 September 2019
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. Elisanne Biemans, ebiemans@eurotrol.com
Device Information
| Device name | REF |
|---|---|
| HemoTrol® Duo Low | AN01624A01 |
| HemoTrol® Duo Normal | AN01624A02 |
| HemoTrol® Duo High | AN01624A03 |
Classification
Class II (21 CFR 864.8625) GGM – control, Hemoglobin
Predicate Device
Eurotrol HemoTrol® WB 510(k) number: K182744
Device Description
HemoTrol® Duo is an assayed hemoglobin quality control material intended for professional use in the verification of the performance characteristics of the HemoCue® 301 and HemoCue® 801 systems. HemoTrol® Duo contains stroma-free bovine hemolysate with hemoglobin in cyanmethemoglobin (CNMetHb) form and a bioburden-controlling agent. For daily quality control, three physiological relevant levels are available.
HemoTrol® Duo solutions are filled in reclosable plastic primary containers. Each bottle contains 1.0 ml of HemoTrol® Duo 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.
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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. Underneath the word is the tagline "Your Global Reference Point for Quality Control" in a smaller, lighter font.
Intended Use
New Device
HemoTrol® Duo is an assayed quality control material for professional use to verify the performance characteristics of the HemoCue® Hb 801 System and Hemotrol® Hb 301 System. HemoTrol® Duo is intended for the quantitative determination of hemoglobin.
Predicate Device
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.
The indication for use for HemoTrol® Duo is identical to the predicate device.
| Parameter | Similarities | Differences |
|---|---|---|
| Analyte | Hemoglobin | None |
| Analyte Concentration | Cover clinical relevant range: | |
| Hb301 Analyzer: 70 - 179 g/L | ||
| Hb801 Analyzer: 65 – 156 g/L | Predicate device also includes: | |
| Hb301 Analyzer: not defined | ||
| Hb801 Analyzer: 95-160 g/L | ||
| Color of liquid | Reddish | None |
| Contents | Purified bovine hemolysate and | |
| preservatives. | New 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. | None | |
| Number of Levels | 3 levels: Low, Normal, High | None |
| Open vial stability | 31 days at 30°C | 31 days at 2-8°C |
| Primary Container | Reclosable plastic primary containers | |
| with polypropylene caps | None | |
| Principle of Operations | The absorbance is measured by using | |
| a dual wavelength spectrophotometric | ||
| technology at 506 and 880 nm. | None | |
| 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, and two gray ovals on either side of the circle. Below the logo is the word "Eurotrol" in a bold, sans-serif font. Below the word "Eurotrol" is the phrase "Global Reference Point for Quality Control" in a smaller, sans-serif font.
Your G
| 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 |
| Intended user | POC and laboratory | None |
Performance Data
Precision/Reproducibility:
Three batches of control material of each of the levels was tested on both analyzers - HemoCue Hb 301 System and HemoCue Hb 801 System. The samples were tested with five replicates per day over five operating days on 3 sites. Total precision was within the defined acceptance criteria.
HemoCue Hb301 System
| Level | Mean (g/L) | SD (g/L) | CV (%) |
|---|---|---|---|
| Low | 70.2 | 2.0 | 2.9 |
| Normal | 129.8 | 3.2 | 2.4 |
| High | 168.6 | 3.8 | 2.2 |
HemoCue Hb801 System
| Level | Mean (g/L) | SD (g/L) | CV (%) |
|---|---|---|---|
| Low | 65.0 | 1.1 | 1.7 |
| Normal | 117.0 | 1.5 | 1.2 |
| High | 154.5 | 1.6 | 1.0 |
Open Stability:
Nine (9) batches were monitored to determine the in-use stability. Three (3) batches of each level were monitored at three (3) time points for a total of 34 days at 30°C. Based on this study, HemoTrol Duo is stable for 31 days when stored at 30℃.
Closed Stability:
21 batches of a quality control were monitored to determine the shelf life. Three (3) batches of the three HemoTrol Duo levels (9 in total) were monitored up to 337 days at 2-8°C. The samples used were produced according the regular process of HemoTrol Duo. The total hemoglobin levels were measured on the HemoCue® Hb 301 and HemoCue® Hb 801 systems. Based on this study, HemoTrol Duo is stable for 336 days when stored at 2-8ºC.
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Image /page/6/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 tagline "Your Global Reference Point for Quality Control" in a smaller, lighter font.
Expected values and Value Assignment:
Three levels of control solution are available.
For batch acceptance three samples of control materials are evaluated on three HemoCue Hb301 Systems, with three batches of microcuvettes. Each sample is measured once per microcuvette batch, providing 27 replicates per analyzer. If mean value of the 27 measurements performed on the HemoCue Hb301 System is between the 'target acceptance range' (see below) the batch can be released for value assignment.
| HemoTrol Duo Level | Production acceptance range on Hb301 (g/L) |
|---|---|
| Low | 70.0 ± 2.5 |
| Normal | 130.0 ± 2.5 |
| High | 170.0 ± 2.5 |
When the batch is released for value assignment the three samples of control materials are also evaluated on three HemoCue Hb801 Systems, with three batches of microcuvettes. An assigned value is subsequently determined based on each set of 27 measurements and is thus batch and analyzer specific. To determine the assigned value and range the mean value of the 27 measurements is combined with a fixed range:
| HemoTrol Duo Level | Label range (g/L) |
|---|---|
| Low | Measured mean ± 12 |
| Normal | Measured mean ± 21 |
| High | Measured mean ± 27 |
Conclusion
Based on the demonstrated intended use, performance characteristics and comparison of technical characteristics HemoTrol® Duo is deemed substantially equivalent to the predicate device: Eurotrol HemoTrol WB (K182744).