COULTER 5C CELL CONTROL

K060464 · Beckman Coulter, Inc. · JPK · Mar 28, 2006 · Hematology

Device Facts

• Record ID: K060464
• Device Name: COULTER 5C CELL CONTROL
• Applicant: Beckman Coulter, Inc.
• Product Code: JPK · Hematology
• Decision Date: Mar 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Indications for Use

5C Cell control is a hematology quality control mixture used to monitor the performance of coulter hematology analyzers listed on the Table of Expected Results in conjunction with specific Coulter reagents. The assigned values and expected ranges on the Table of Expected Results can be used to monitor instrument performance.

Device Story

5C Cell Control is a stabilized hematology quality control mixture; composed of treated human erythrocytes, stabilized platelet-sized components, and fixed erythrocytes simulating leukocytes. Used in clinical laboratory settings to monitor daily performance of automated hematology analyzers. Provided in three levels (Normal, Abnormal I, Abnormal II). Healthcare providers analyze the control on the instrument; compare results against assigned values and expected ranges provided in the Table of Expected Results. Discrepancies in control values indicate potential instrument performance issues, prompting calibration or maintenance. Benefits include ensuring accuracy and reliability of patient hematology test results.

Clinical Evidence

Bench testing only. Stability studies were conducted to support claims of 13 days (open vial) and 95 days (closed vial) for the RDW-SD parameter.

Technological Characteristics

Reference material composed of treated, stabilized human erythrocytes in isotonic, bacteriostatic medium; includes platelet-sized components and fixed erythrocytes. Derived parameter (RDW-SD) calculated from RBC histogram data. No changes to formulation or manufacturing process.

Indications for Use

Indicated for use as a quality control material for hematology analyzers to monitor instrument performance for parameters including WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, and differential leukocyte counts.

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 (cleared as COULTER® PX Cell Control)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE

A. 510(k) Number:
K060464

B. Purpose for Submission:
The parameter RDW-SD (Red Cell Distribution Width-Standard Deviation) is being added to the Coulter 5C Cell Control.

C. Manufacturer and Instrument Name:
Beckman Coulter, Inc., Coulter 5C Cell Control is intended to be used on a new automated hematology analyzer called the Coulter LH780 which will be capable of analyzing the RDW-SD parameter.

D. Type of Test or Tests Performed:
Coulter 5C Cell Control is a quality control material for the parameters WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, Ly%, Mo%, Ne%, Eo%, Ba%, Ly#, Mo#, Ne#, Eo#, and Ba#.

E. System Descriptions:

1. Device Description:
5C Cell Control is a hematology quality control mixture intended to be used with automated cell counters and differential cell counters. It is prepared from stabilized human blood so that repeated measurements by an automated cell counter, or differential cell counter, can be made to monitor instrument daily performance. 5C Cell Control consists of treated stabilized human erythrocytes, a stabilized platelet sized component, and fixed erythrocytes that simulate leukocytes. Three levels of varying component concentrations (Abnormal II, Abnormal I, and Normal) are offered.

2. Principles of Operation:
N/A

3. Modes of Operation:
N/A

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4. Specimen Identification:
N/A

5. Specimen Sampling and Handling:
N/A

6. Calibration:
N/A

7. Quality Control:
5C Cell Control has assigned values and expected ranges which can be used to monitor instrument performance.

8. Software: N/A

FDA has reviewed applicant's Hazard Analysis and Software Development processes for this line of product types:
Yes _______ or No _______

F. Regulatory Information:

1. Regulation section:
21 CFR 864.8625

2. Classification:
Class II

3. Product code:
JPK

4. Panel:
Hematology (81)

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G. Intended Use:

1. Indication(s) for Use:

5C Cell control is a hematology quality control mixture used to monitor the performance of coulter hematology analyzers listed on the Table of Expected Results in conjunction with specific Coulter reagents. The assigned values and expected ranges on the Table of Expected Results can be used to monitor instrument performance.

2. Special Conditions for Use Statement(s):

N/A

H. Substantial Equivalence Information:

1. Predicate Device Name(s) and 510(k) numbers:

COULTER® 5C® Cell Control, K912133 (cleared as COULTER® PX Cell Control)

2. Comparison with Predicate Device:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Product Description | 5C Controls consist of treated, stabilized human erythrocytes in an isotonic, bacteriostatic medium. It also contains a stabilized platelet-sized component, and fixed erythrocytes to simulate leukocytes. | Same |
| Intended Use | 5C Cell Control is a hematology quality control mixture used to monitor the performance of Coulter hematology analyzers listed on the Table of Expected Results in conjunction with specific coulter reagents. The assigned values and expected | Same |

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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Cellular Populations | ranges on the Table of Expected Results can be used to monitor instrument performance. | Same |
| Manufacturing Process | Erythrocytes, platelets, lymphocytes, monocytes, neutrophils, and eosinophils. | Same |
| Sample Preparation | 5C Cell Control is prepared from pre-screened units of whole human blood as well as animal blood. Stabilized RBC and platelet pools and fixed lymphocyte, monocyte, neutrophil, and eosinophils pools are manufactured independently. These pools are combined to provide the desired target ranges. | Same |
| Final Product Form | No special sample preparation is required. The control is a ready to use product. The control is warmed to ambient temperature, mixed by hand and analyzed on specified hematology analyzers. | Same |
| Open Vial Stability | Three levels, liquid, ready to use. | Same |
| Closed Vial Stability | 13 events over 13 days when stored at 2-8° C. | Same |
| | 95 days when stored at 2-8° C. | Same |

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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Assayed Parameters | WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, PCT, PDW, Ly%, Mo%, Ne%, Eo%, Ba%, Ly#, Mo#, Ne#, Eo#, Ba# | Same with the additional parameter RDW-SD. |

I. Special Control/Guidance Document Referenced (if applicable):

N/A

J. Performance Characteristics:

1. Analytical Performance:

a. Accuracy:

N/A

b. Precision/Reproducibility:

N/A

c. Linearity:

N/A

d. Carryover:

N/A

e. Interfering Substances:

N/A

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2. Other Supportive Instrument Performance Data Not Covered Above:

For Open Vial Stability and Closed Vial Stability, a total of nine lots of 5C Controls were tested through expiration starting near the end of the product's shelf life. Two tubes per level (3) were evaluated. Open Vial Stability was determined to be 13 events over 13 days when stored at 2-8° C. Closed Vial Stability was determined to be 95 days when stored at 2-8° C.

K. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

L. Conclusion:

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

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