COULTER BODY FLUID CONTROL

K082162 · Beckman Coulter, Inc. · JPK · Feb 3, 2009 · Hematology

Device Facts

• Record ID: K082162
• Device Name: COULTER BODY FLUID CONTROL
• Applicant: Beckman Coulter, Inc.
• Product Code: JPK · Hematology
• Decision Date: Feb 3, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Indications for Use

The Beckman-Coulter Body Fluid Control is a hematology quality control material used to monitor the performance and verify the measuring range of the body fluid cycle of the UniCel® DxH 800 COULTER Cellular Analysis System.

Device Story

Body Fluid Control is a reference product consisting of treated, stabilized human erythrocytes in an isotonic medium, with a platelet-sized component and fixed erythrocytes to simulate leukocytes. It is used in clinical laboratories to monitor the accuracy and precision of the UniCel® DxH 800 COULTER Cellular Analysis System during body fluid cycle counting. By comparing instrument measurements against assigned values and expected ranges provided in the product documentation, laboratory personnel verify the system's performance and measurable range. The control helps ensure the reliability of hematology analysis, ultimately supporting accurate clinical decision-making for patient samples processed on the analyzer.

Clinical Evidence

Bench testing only. Stability studies were conducted to support claims of 18 events within 16 days for open vials and 120 days for closed vials. No clinical data was required or presented.

Technological Characteristics

Reference material composed of treated, stabilized human erythrocytes in an isotonic medium, including a platelet-sized component and fixed erythrocytes to simulate leukocytes. Designed for use with the UniCel® DxH 800 COULTER Cellular Analysis System. No specific ASTM standards or software algorithms are described for the control material itself.

Indications for Use

Indicated for use as a quality control material to monitor performance and verify the measuring range of the body fluid cycle on the UniCel® DxH 800 COULTER Cellular Analysis System.

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

• COULTER® 5C® Cell Control (K912133, K060464)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE

A. 510(k) Number:
K082162

B. Purpose for Submission:
Clearance of new device

C. Measurand:
Erythrocytes, Monocytes, Lymphocytes

D. Type of Test:
Quality Control Material

E. Applicant:
Beckman-Coulter INC

F. Proprietary and Established Names:
Coulter Body Fluid Control

G. Regulatory Information:
1. Regulation section:
21 CFR 864.8625
2. Classification:
Class II
3. Product code:
JPK
4. Panel:
81 Hematology

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H. Intended Use:

1. Intended use(s):

The Beckman-Coulter Body Fluid Control is a hematology quality control material used to monitor the performance and verify the measuring range of the body fluid cycle of the UniCel® DxH 800 COULTER Cellular Analysis System.

2. Indication(s) for use:

3. Special conditions for use statement(s):

4. Special instrument requirements:

UniCel® DxH 800 COULTER Cellular Analysis System (K081930)

I. Device Description:

The Beckman-Coulter Body Fluid Control is a hematology quality control mixture intended to be used with the UniCel® DxH 800 COULTER Cellular Analysis System (K081930). It consists of 3 levels of treated, stabilized human erythrocytes, a stabilized platelet-sized component, and fixed erythrocytes that simulate leukocytes. The platelet-sized components are not assayed nor reported in the body fluid cycle.

J. Substantial Equivalence Information:

1. Predicate device name(s):

COULTER® 5C® Cell Control (cleared as COULTER® PX Cell Control)

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

K912133, K060464

3. Comparison with predicate:

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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Quality control material intended to monitor the performance of a hematology analyzer | same |
| Product composition | Treated, stabilized human erythrocytes in an isotonic medium, and stabilized platelet-sized component, and fixed erythrocytes to simulate leukocytes | same |
| Levels | 3 levels | same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Cellular Population | Erythrocytes, Platelets, Lymphocytes, and monocytes | Erythrocytes, platelets, lymphocytes, monocytes, neutrophils, and eosinophils |
| Assayed Parameters | RBC and TNC | WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, Ly%, Mo%, Ne%, Eo%, Ba%, Ly#, Mo#, Ne#, Eo#, Ba# |
| Analyzers | UniCel® DxH 800 | COULTER® LH 780, LH 750, GENS*S, STKS, LH 500, HmX, HmX w. Autoloader, MAXM, & MAXM w. Autoloader |

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

L. Test Principle:

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

# 1. Analytical performance:

a. Precision/Reproducibility:

Body Fluids Level 1

| % CV | | |
| --- | --- | --- |
| | RBC | TNC |
| Lot 1 | 4.0 | 8.3 |
| Lot 2 | 4.1 | 10.2 |
| Lot 3 | 4.2 | 9.2 |

Body Fluids Level 2

| % CV | | |
| --- | --- | --- |
| | RBC | TNC |
| Lot 1 | 0.6 | 1.8 |
| Lot 2 | 0.6 | 1.9 |
| Lot 3 | 0.9 | 1.8 |

Body Fluids Level 3

| % CV | | |
| --- | --- | --- |
| | RBC | TNC |
| Lot 1 | 1.2 | 1.3 |
| Lot 2 | 1.1 | 1.4 |
| Lot 3 | 1.2 | 1.1 |

b. Linearity/assay reportable range: N/A
c. Traceability, Stability, Expected values (controls, calibrators, or methods):

The product was evaluated for real-time open and closed vial stability.

d. Detection limit: N/A
e. Analytical specificity: N/A
f. Assay cut-off: N/A

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2. Comparison studies:
a. Method comparison with predicate device:
N/A
b. Matrix comparison:
N/A

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

4. Clinical cut-off:
N/A

5. Expected values/Reference range:
N/A

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

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

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