LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV

K091303 · Bio-Rad Laboratories · JPK · Aug 2, 2010 · Hematology

Device Facts

• Record ID: K091303
• Device Name: LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV
• Applicant: Bio-Rad Laboratories
• Product Code: JPK · Hematology
• Decision Date: Aug 2, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Indications for Use

Liquichek Hematology-16 Control LV is intended for use as an assayed hematology control to monitor the precision of hematology analyzers that measure the following parameters: GRAN (Granulocytes), HCT (Hematocrit), HGB (Hemoglobin), LYMPH (Lymphocytes), MCH (Mean Corpuscular Hemoglobin), MCHC (Mean Corpuscular Hemoglobin Concentration), MCV (Mean Corpuscular Volume), MID (Mid-Sized Cells), MONO (Monocytes), MPV (Mean Platelet Volume), PLT (Platelets), RBC Red Blood Cells), RDW (Red Blood Cell Distribution Width), and WBC (White Blood Cells).

Device Story

Liquichek Hematology-16 Control LV is an assayed quality control material used to monitor the precision of hematology analyzers. It consists of a suspension of stabilized lysable human erythrocytes, simulated platelet components, simulated white cells, and animal-derived constituents in a stabilizing medium. The device is provided in 1.5 mL glass vials with screw caps. It is used in clinical laboratory settings by technicians or laboratory staff to verify the performance of hematology analyzers by comparing measured values against assigned ranges. The control is stored at 2°C to 8°C, with a shelf life of 160 days and an open-vial stability of 21 days. By providing an objective assessment of instrument precision, it helps ensure the reliability of patient blood cell counts and indices.

Clinical Evidence

No clinical data. Bench testing performed per CLSI EP5-A2 guidelines. Precision study conducted over 20 days (two runs/day, duplicate) across three levels of control. Total precision standard deviations were compared to instrument manufacturer claims using chi-square tests; all p-values were > 0.05, indicating no statistically significant difference in precision performance.

Technological Characteristics

Suspension of stabilized lysable human erythrocytes, simulated platelet components, simulated white cells, and animal-derived constituents in a stabilizing medium. 1.5 mL glass vials with screw caps. Storage: 2°C to 8°C. Shelf life: 160 days. Open vial stability: 21 days. Standard referenced: CLSI EP5-A2.

Indications for Use

Indicated for use as an assayed hematology control to monitor the precision of hematology analyzers measuring blood cell parameters (GRAN, HCT, HGB, LYMPH, MCH, MCHC, MCV, MID, MONO, MPV, PLT, RBC, RDW, WBC). No specific patient population or contraindications described.

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

• Liquichek Hematology-16 Control (formerly known as TRI-COUNT 16) (k902389)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k091303

B. Purpose for Submission:
Modification of a cleared device

C. Measurand:
WBC, LYMPH, MONO, MID, GRAN, RBC, HGB, HCT, MCH, MCHC, MCV, RDW, PLT and MPV

D. Type of Test:
Assayed quality control material

E. Applicant:
Bio-Rad Laboratories

F. Proprietary and Established Names:
Liquichek Hematology-16 Control LV

G. Regulatory Information:
1. Regulation section:
21 CFR 864.8625; Hematology quality control
2. Classification:
Class II
3. Product code:
JPK; Mixture, Hematology Quality Control
4. Panel:
Hematology 81

H. Intended Use:
1. Intended use(s):
Liquichek Hematology-16 Control LV is intended for use as an assayed hematology control to monitor the precision of hematology analyzers that measure the following parameters: GRAN (Granulocytes), HCT (Hematocrit), HGB (Hemoglobin), LYMPH (Lymphocytes), MCH (Mean Corpuscular Hemoglobin), MCHC (Mean Corpuscular Hemoglobin Concentration), MCV (Mean Corpuscular Volume), MID (Mid-Sized Cells), MONO (Monocytes), MPV (Mean Platelet Volume), PLT (Platelets), RBC Red Blood Cells), RDW (Red Blood Cell Distribution Width), and WBC (White Blood Cells).
2. Indication(s) for use:
Same as intended use
3. Special conditions for use statement(s):
Not applicable
4. Special instrument requirements:
Not applicable

I. Device Description:
This product is a suspension of stabilized lysable human erythrocytes, simulated platelet components, simulated white cells and constituents of animal origin in a medium containing stabilizers.

J. Substantial Equivalence Information:

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1. Predicate device name(s):

Liquichek Hematology-16 Control (formerly known as TRI-COUNT 16)

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

k902389

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Liquichek Hematology-16 Control LV is intended for use as an assayed hematology control to monitor the precision of hematology analyzers that measure the following parameters: GRAN (Granulocytes), HCT (Hematocrit), HGB (Hemoglobin), LYMPH (Lymphocytes), MCH (Mean Corpuscular Hemoglobin), MCHC (Mean Corpuscular Hemoglobin Concentration), MCV (Mean Corpuscular Volume), MID (Mid-Sized Cells), MONO (Monocytes), MPV (Mean Platelet Volume), PLT (Platelets), RBC Red Blood Cells), RDW (Red Blood Cell Distribution Width), and WBC (White Blood Cells). | Liquichek Hematology-16 Control is a hematology reference control used in monitoring determinations of blood cell values on cell counters. |
| Form | Liquid | Same |
| Matrix | Suspension containing blood cells | Same |
| Preservatives | Contains preservatives | Same |
| Storage (unopened) | 160 days at 2°C to 8°C | Same |
| Open vial claim | 21 days at 2°C to 8°C | Same |
| Analytes | GRAN (Granulocytes), HCT (Hematocrit), HGB (hemoglobin), LYMPH (Lymphocytes), MCH (Mean Corpuscular Hemoglobin), MCHC (Mean Corpuscular Hemoglobin Concentration), MCV (Mean Corpuscular Volume), MID (mid-Sized Cells)/ Mono (Monocytes), MPV (Mean Platelet Volume), PLT (Platelets), RBC (Red Blood Cells), RDW (Red Blood Cells Distribution Width), WBC (White Blood Cells) | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Fill Volume | 1.5 mL | 3.0 mL |
| Vial Type | Glass vials with screw caps | Glass tubes with pierceable caps |

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

CLSI EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods

L. Test Principle:

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The use of quality control materials is indicated as an objective assessment of the precision of methods and techniques in use and is an integral part of good laboratory practices. Three levels of control are available to allow monitoring of performance.

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

### 1. Analytical performance:

#### a. Precision/Reproducibility:

Each level of control was tested two times per day, in duplicate, for 20 days as outlined in the CSLI EP5-A2 guideline. The total precision standard deviations for Liquichek Hematology-16 Control LV (Table 1) were compared to the instrument manufacturer precision standard deviation (Table 2) and the statistical p-values were calculated utilizing a chi-square test. The observed differences between the study precision results and the instrument manufacturer precision claims are considered statistically significant when the p-values are < 0.05. The p-values obtained from this study are > 0.05 (Table 3), which indicates that the observed differences are not statistically significant.

Table 1: Total precision standard deviation for Liquicheck Hematology-16 Control LV

| Parameter | RBC Cells/μL | Hbg g/dL | MCV fL | RDW % | PLT Cells/μL | MPV fL | WBC Cells/μL | LY% | MO% | GR% |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Low | 0.025 | 0.076 | 0.542 | 0.198 | 1.654 | 0.124 | 0.096 | 1.243 | 1.206 | 0.946 |
| Normal | 0.027 | 0.103 | 0.502 | 0.153 | 4.861 | 0.062 | 0.133 | 1.066 | 0.906 | 0.794 |
| High | 0.029 | 0.116 | 0.560 | 0.309 | 11.089 | 0.075 | 0.227 | 0.643 | 0.382 | 0.756 |

Table 2: Instrument Manufacturer Precision Standard Deviation

| Parameter | RBC Cells/μL | Hbg g/dL | MCV fL | RDW % | PLT Cells/μL | MPV fL | WBC Cells/μL | LY% | MO% | GR% |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Low | 0.040 | 0.120 | 0.720 | 0.348 | 3.780 | 0.198 | 0.170 | 2.964 | 1.136 | 1.500 |
| Normal | 0.040 | 0.120 | 0.720 | 0.318 | 9.900 | 0.198 | 0.170 | 2.438 | 0.100 | 2.138 |
| High | 0.042 | 0.140 | 0.768 | 0.322 | 17.435 | 0.198 | 0.362 | 2.059 | 0.100 | 2.707 |

Table 3: Statistical "p" Values for Total Precision SD

| Parameter | RBC Cells/μL | Hbg g/dL | MCV fL | RDW % | PLT Cells/μL | MPV fL | WBC Cells/μL | LY% | MO% | GR% |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Low | 1.0000 | 1.0000 | 0.9818 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 0.2247 | 1.0000 |
| Normal | 0.9998 | 0.9499 | 0.9976 | 1.0000 | 1.0000 | 1.0000 | 0.9985 | 1.0000 | 0.1925 | 1.0000 |
| High | 0.9997 | 0.9841 | 0.9931 | 0.6311 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 0.9864 | 1.0000 |

b. Linearity/assay reportable range:
Not Applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Stability studies were performed to determine the open vial and shelf life

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stability for the Liquichek Hematology-16 Control LV. Two lots of data are provided for each study. These studies are performed in such a manner as to mimic the handling of product in the customer's hands following opening of these products and their preparation for use. The open vial study time is typically defined to be at least 20% longer than the claimed open vial stability for the product and tested at least at four time points: at the beginning at the end and two time points during the middle of the study (T-zero, T-M1, T-M2 and T-Final + 20%). The acceptance criterion is generally defined as the T-Final + 20% being within the expected ranges.

Open Vial Stability: All parameters are stable for 21 days when stored at 2°-8°C.

Shelf life stability: All parameters are stable for 160 days at 2 -8° C.

The review of the data was within acceptable limits.

Value Assignment: The mean values printed in the Liquichek Hematology-16 Control LV package insert are derived from replicate analyses and are specific for each lot of product. The tests listed are performed by manufacturer or independent laboratories using a representative sampling of each product.

Laboratory results may vary from the listed values. Variations over time and between laboratories may be caused by differences in laboratory technique, instrumentation calibrating methods, reagents or by any stated limitations for this product. It is recommended that each laboratory establish its own means and acceptable ranges with each lot of Liquichek Hematology-16 Control LV.

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

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
Expected values are provided in the Package Insert accompanying the product.

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

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O. Conclusion:

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

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