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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a formal table separate from the performance results. Instead, for "Expected values and Value Assignment," it details "Production acceptance range on Hb301" for batch release and "Label range" calculated from the measured mean. For precision/reproducibility and stability, the acceptance criteria are implied by the reported results being "within the defined acceptance criteria."

Implicit Acceptance Criteria and Reported Device Performance:

Study Category	Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Precision/Reproducibility	Standard Deviation (SD) & Coefficient of Variation (CV)	"Total precision was within the defined acceptance criteria." Specific numerical criteria for SD/CV are not presented.	HemoCue Hb301 System: - Low: Mean 70.2 g/L, SD 2.0 g/L, CV 2.9% - Normal: Mean 129.8 g/L, SD 3.2 g/L, CV 2.4% - High: Mean 168.6 g/L, SD 3.8 g/L, CV 2.2% HemoCue Hb801 System: - Low: Mean 65.0 g/L, SD 1.1 g/L, CV 1.7% - Normal: Mean 117.0 g/L, SD 1.5 g/L, CV 1.2% - High: Mean 154.5 g/L, SD 1.6 g/L, CV 1.0%
Open Vial Stability	Duration (days) at 30°C	"is stable for 31 days when stored at 30℃." (This is both the criterion and the result based on the study).	31 days stable when stored at 30°C.
Closed Vial Stability	Duration (days) at 2-8°C	"is stable for 336 days when stored at 2-8ºC." (This is both the criterion and the result based on the study).	336 days stable when stored at 2-8°C.
Value Assignment (Batch Release for Hb301)	Mean value (g/L)	- Low: 70.0 ± 2.5 g/L - Normal: 130.0 ± 2.5 g/L - High: 170.0 ± 2.5 g/L	Not explicitly reported as device performance for new batches, but the method for achieving this is described. The batch "can be released for value assignment" if it meets these ranges.
Value Assignment (Label Range for Hb801)	Label range (g/L)	- Low: Measured mean ± 12 - Normal: Measured mean ± 21 - High: Measured mean ± 27	Not explicitly reported as a performance metric, but rather a calculation method for the assigned value and range.

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

Precision/Reproducibility:
- Sample Size: Three batches of control material for each of the three levels (Low, Normal, High), tested with five replicates per day over five operating days on 3 sites. This totals to 3 batches * 3 levels * 5 replicates * 5 days * 3 sites = 675 individual measurements per analyzer system (Hb301 and Hb801).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the study was conducted to demonstrate device performance, implying a prospective study design for this submission.
Open Stability:
- Sample Size: Nine batches (3 batches of each level), monitored at three time points for a total of 34 days.
- Data Provenance: Not explicitly stated.
Closed Stability:
- Sample Size: 21 batches of control material (3 batches of the three HemoTrol Duo levels "9 in total" suggests 9 batches tested, 3 per level, which were then monitored to determine shelf life, potentially across different production runs?). The phrasing "21 batches of a quality control were monitored" and then "Three (3) batches of the three HemoTrol Duo levels (9 in total)" is a bit conflicting. It safely confirms at least 9 batches (3 per level) were used, monitored up to 337 days.
- Data Provenance: Not explicitly stated.
Value Assignment (Batch Release):
- Sample Size: Three samples of control materials (presumably from a batch being assessed) evaluated on three HemoCue Hb301 Systems, with three batches of microcuvettes. Each sample is measured once per microcuvette batch, providing 27 replicates per analyzer being qualified. This is a batch release process, not a test set for the device's overall performance.
- Data Provenance: Not explicitly stated; refers to ongoing production processes.

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

N/A. This device is a quality control material for an analyzer system (HemoCue Hb 301 and Hb 801). The "ground truth" (or target values) for the control material is established through objective laboratory measurements on the respective analyzer systems, not through expert consensus on qualitative data or imaging. Therefore, no experts in the conventional sense (e.g., radiologists) are involved in establishing the ground truth of the control material itself.

4. Adjudication Method

N/A. As the ground truth is established by objective measurements on the specified analyzer systems, there is no need for an adjudication method by human experts. The process for "Value Assignment" described (mean of 27 measurements) serves a similar purpose of establishing a reliable target value.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is typically used for diagnostic devices that involve human interpretation (e.g., medical imaging). This device is a quality control material, which is measured objectively by an automated or semi-automated analyzer.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, implicitly. The performance data for precision/reproducibility and stability are measurements of the control material's characteristics when analyzed by the HemoCue Hb 301 and Hb 801 systems, which are objective measurement devices. Human involvement is primarily in operating the system and recording results, not in interpreting qualitative data, making this essentially a standalone performance assessment of the control material with the specified analyzers.

7. Type of Ground Truth Used

The ground truth for HemoTrol® Duo is established through objective, quantitative measurements of hemoglobin concentration using the HemoCue® Hb 301 and HemoCue® Hb 801 Systems. This is akin to a reference measurement or instrument-generated data, where the analyzer itself defines the 'truth' for the control material within its operational parameters.

8. Sample Size for the Training Set

N/A. This device is a quality control material and is not an AI/ML algorithm that requires a training set. The descriptions of "batches" refer to manufacturing lots of the control material, not data used for training an algorithm.

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

N/A. As above, this device does not involve an AI/ML algorithm or a training set.

Summary

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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

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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)

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

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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/LHb801 Analyzer: 65 – 156 g/L	Predicate device also includes:Hb301 Analyzer: not definedHb801 Analyzer: 95-160 g/L
Color of liquid	Reddish	None
Contents	Purified bovine hemolysate andpreservatives.	New device does not containstabilized red blood cells
Filling volume	1 ml	None
Intended Use	Quality Control material forprofessional use to verify theperformance characteristics of aspecific 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 containerswith polypropylene caps	None
Principle of Operations	The absorbance is measured by usinga dual wavelength spectrophotometrictechnology at 506 and 880 nm.	None
Procedure	Allow the vial to stand for 15 minutes atroom temperatureMix the vial before sampling.Do not fill the cuvette from the vial.Dispense a drop of the control materialonto a hydrophobic surface.Fill the cuvette according to themanufacturer's instructions.Wipe any excess material from the vialand 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 areplaced in a plastic blister and packed ina product box together with thecombined 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).

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.