HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High

K182744 · Eurotrol B.V. · GGM · Feb 1, 2019 · Hematology

Device Facts

• Record ID: K182744
• Device Name: HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High
• Applicant: Eurotrol B.V.
• Product Code: GGM · Hematology
• Decision Date: Feb 1, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended 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.

Device Story

HemoTrol® WB is an assayed quality control material used by healthcare professionals in point-of-care and laboratory settings to verify the performance of HemoCue® Hb 301 and Hb 801 hemoglobin analyzers. The device consists of bovine red blood cells with hemoglobin lysates, MetHb, and stabilizers, provided in three physiological levels (Low, Normal, High). Users dispense a drop of the control material onto a hydrophobic surface and fill the analyzer cuvette according to manufacturer instructions. The analyzer measures absorbance via dual-wavelength spectrophotometry (506 nm and 880 nm) to determine hemoglobin concentration. By comparing the analyzer's output against the provided assay values, clinicians verify the accuracy and precision of the testing system, ensuring reliable patient hemoglobin results.

Clinical Evidence

No clinical data. Bench testing only. Precision/reproducibility evaluated on HemoCue Hb 301 and Hb 801 systems using three levels of control material over five days. Total precision (%CV) ranged from 0.44% to 1.12%. Shelf-life stability (108 days) and in-use stability (31 days) were validated.

Technological Characteristics

Assayed quality control material containing purified bovine red blood cells, hemoglobin lysate, and preservatives. Primary containers are reclosable plastic bottles with colored polypropylene caps. Analyte measurement via dual-wavelength spectrophotometry (506 nm and 880 nm). Storage at 2–8°C. Complies with CLSI EP05-A3 and EP25-A guidelines.

Indications for Use

Indicated for professional use in clinical laboratories and point-of-care settings to verify the precision and accuracy of HemoCue Hb 301 and HemoCue Hb 801 systems for hemoglobin measurement.

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

• Eurotrol HemoTrol (K964052)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM

A. 510(k) Number:
K182744

B. Purpose for Submission:
Clearance of control materials for the HemoCue Hb 301 System and HemoCue Hb 801 System

C. Measurand:
Hemoglobin

D. Type of Test:
Quantitative determination of hemoglobin

E. Applicant:
EUROTROL B.V.

F. Proprietary and Established Names:
HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High

G. Regulatory Information:

1. Regulation section:
21 CFR 864.8625, Hematology quality control mixture

2. Classification:
Class II

3. Product code:
GGM, Control, Hemoglobin

4. Panel:
Hematology (81)

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H. Intended Use:

1. Intended use(s):

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.

2. Indication(s) for use:

Same as intended use

3. Special conditions for use statement(s):

For prescription use only

4. Special instrument requirements:

HemoCue Hb 301 System and HemoCue Hb 801 System

I. 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 physiologically 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; Normal: white cap; High: blue cap). Two 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.

J. Substantial Equivalence Information:

1. Predicate device name(s):

HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High

2. Predicate 510(k) number(s):

K964052

3. Comparison with predicate:

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| Similarities | | |
| --- | --- | --- |
| Item | Candidate
HemoTrol WB - Low,
HemoTrol WB - Normal,
HemoTrol WB - High | Predicate
Eurotrol HemoTrol
K964052 |
| Intended 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. | HemoCue HemoTrol is an assayed hematology control intended for use in the verification of the accuracy and precision of the HemoCue B-Hemoglobin and the HemoCue Hb 201 systems. |
| Analyte | Hemoglobin | Same |
| Fill volume | 1 mL | Same |
| Number of Levels | 3 levels: Low, Normal, High | Same |
| Open vial stability | 31 days | Same |
| Primary Container | Reclosable plastic primary containers with polypropylene caps | Same |
| 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. | Same |
| Secondary Packaging | Two 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. | Same |
| Storage temperature | 2–8°C | Same |
| Where used | Point of care (POC) sites and clinical laboratory | Same |

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| Differences | | |
| --- | --- | --- |
| Item | Device
HemoTrol WB - Low,
HemoTrol WB - Normal,
HemoTrol WB - High | Predicate
Eurotrol HemoTrol
K964052 |
| Analyte Concentration Range | 95–160 g/L | 80–160 g/L |
| Contents | Contains purified bovine red blood cells with hemoglobin lysate and preservatives | Contains purified bovine hemoglobin lysate but not stabilized bovine red blood cells or preservatives |
| Target analyzer | HemoCue Hb 301 System and HemoCue Hb 801 System | HemoCure B-Hemoglobin and HemoCue Hb 201 systems |
| Operations | The absorbance is measured by using a dual wavelength spectrophotometric technology. Measurements are performed at 506 nm and 880 nm. | The absorbance is measured by using a dual wavelength spectrophotometric technology. Measurements are performed at 570 nm and 880 nm. |

## K. Standard/Guidance Document Referenced (if applicable):

- CLSI EP05-A3; Evaluation of Precision Performance of Qualitative Measurement Methods; Approved Guideline - Third Edition.
- CLSI EP25-A; Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline

## L. Test Principle:

The absorbance of hemoglobin in the control materials is measured by using a dual wavelength (506 nm and 880 nm) spectrophotometric technology in the HemoCue Hb 301 and HemoCue Hb 801 Systems.

## M. Performance Characteristics (if/when applicable):

### 1. Analytical performance:

#### a. Precision/Reproducibility:

One lot of control material at three hemoglobin levels was tested on both analyzers - HemoCue Hb 301 System and HemoCue Hb 801 System. The samples were tested with five replicates per analyzer per day over five operating days. Total precision was within the defined acceptance criteria.

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HemoCue Hb 301 System:

| Hemoglobin level | Mean (g/L) | SD (g/L) | %CV |
| --- | --- | --- | --- |
| Low | 103.20 | 1.13 | 1.10 |
| Normal | 139.90 | 1.57 | 1.12 |
| High | 171.90 | 1.90 | 1.10 |

HemoCue Hb 801 System:

| Hemoglobin level | Mean (g/L) | SD (g/L) | %CV |
| --- | --- | --- | --- |
| Low | 96.40 | 0.81 | 0.84 |
| Normal | 132.60 | 0.89 | 0.67 |
| High | 163.50 | 0.72 | 0.44 |

b. Linearity/assay reportable range:

Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Stability- Shelf Life

Shelf life stability at 2–8°C was assessed using control materials of three hemoglobin levels. Three lots of each hemoglobin level were tested with 3–6 replicates per lot per time point. Eight time points between 0 to 127 days were tested on both analyzers - HemoCue Hb 301 System and HemoCue Hb 801 System. Shipping conditions with temperature ranges of either 22–30°C or -10–3°C were applied on Day 7–14. The study data supported the recommended stability claim of 108 days at 2–8°C.

In-use stability

In-use stability at 2–8°C was assessed using control materials of three hemoglobin levels. Five time points (0, 14, 21, 28, and 35 days) were tested on both analyzers - HemoCue Hb 301 System and HemoCue Hb 801 System. Each hemoglobin level was tested with 2–4 replicates per lot per time point. The study data supported the recommended stability claim of 31 days at 2–8°C.

Expected Values

Three physiologically relevant levels are available:

| HemoTrol WB Level | Target Total Hemoglobin (g/L) |
| --- | --- |
| Low | 95 |
| Normal | 130 |
| High | 160 |

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Value Assignment

Value assignment is performed for each new lot of HemoTrol WB. Three samples of control materials were evaluated on three HemoCue Hb 801 Systems, with three lots of microcuvettes. Each sample is measured once per microcuvette lot per analyzer, providing 27 replicates. If the 27 measurements are within the acceptance criteria (4% for Normal and 7% for Low and High), a value range is assigned to the lot as the mean value of these 27 measurements with ±4% for Normal and ±7% for Low and High.

d. Detection limit:
Not applicable

e. Analytical specificity:
Not applicable

f. Assay cut-off:
Not applicable

2. Comparison studies:
a. Method comparison with predicate device:
Not applicable
b. Matrix comparison:
Not applicable

3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable

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4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
Not applicable

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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