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

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 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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K 060464

Image /page/0/Picture/1 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized black circle with two white curved lines running through it. To the right of the circle are the words "BECKMAN" on the top line and "COULTER" on the bottom line, both in a bold, sans-serif font.

MAR 2 8 2006

## 510(k) Summary Parameter Addition (RDW-SD) to COULTER 5C Cell Control

#### 1. Submitted By:

Nancy Nadler Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 11800 SW 147 Avenue, M/C: 31-B06 Miami, Florida 33196-2500 Telephone: [phone] FAX: [phone]

#### 2. Date Submitted:

February 21, 2006

#### 3. Device Name(s):

#### 3.1 Proprietary Names

COULTER® 5C® Cell Control

#### 3.2 Classification Name

Hematology quality control mixture (21 CFR § 864.8625)

#### 4. Predicate Device:

| Candidate(s) | Predicate | Manufacturer | Docket<br>Number |
|------------------------------|--------------------------------------------------------------------------|-----------------------|------------------|
| COULTER® 5C® Cell<br>Control | COULTER® 5C® Cell<br>Control<br>(Cleared as COULTER® PX<br>Cell Control) | Beckman Coulter, Inc. | K912133 |

#### 5. Description:

5C Cell Control is a reference product prepared from treated, stabilized human erythrocytes in an isotonic, bacteriostatic medium. 5C Cell Control also contains a stabilized, platelet-sized component, and fixed erythrocytes to simulate leukocytes. By design, 5C Cell Control confirms and monitors instrument

Beckman Coulter , Inc. 11800 S.W. 147th Avenue Miami, FL 33196-2500

# Mailing Address:

11800 S.W. 147th Avenue P.O. Box 169015 Miami, FL 33116-9015

Customer Service: [phone] Product Information: (800) 526-69321 [phone] [phone] Internet: www.beckmancouiter.com

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accuracy and precision performance by providing measurements for counting, sizing, hemoglobin determination and White Blood Cell differentiation using VCS technology.

#### ి. Intended Use:

5C Cell Control is a hematology quality control material used to monitor the performance of COULTER hematology analyzers listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents (Refer to your Product Manuals or On-line Help System.)

The assigned values and expected ranges on the TABLE OF EXPECTED RESULTS can be used to monitor instrument performance. This product can also be used to establish your own laboratory mean.

#### 7. Comparison to Predicate(s):

COULTER 5C Cell Control with the additional parameter (RDW-SD) is identical to the current COULTER 5C Cell Control. RDW-SD is a derived parameter from the RBC histogram which is obtained on a new COULTER hematology analyzer (5106 submission pending). The control product formulation and manufacturing processes were not modified to obtain the additional parameter.

#### 8. Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution. Stability studies of 5C Cell Control with RDW-SD parameter support the Beckman Coulter stability claims of 13 events within 13 days (open vial) and 95 days (closed vial).

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and tail. The eagle is positioned to the right of a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

MAR 2 8 2000

Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

Ms. Nancy Nadler Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 11800 SW 147 Avenue, M/C: 31-B06 Miami, Florida 33196-2500

> k060464 Trade/Device Name: COULTER® 5C® Cell Control Regulation Number: 21 CFR § 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: II Product Code: JPK Dated: February 21, 2006 Received: February 22, 2006

Dear Ms. Nadler:

Re:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 -

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Robert Beckerh

Robert L. Becker, Jr., MD, PK Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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page 1 of

510(k) Number (if known):

Device Name: COULTER® 5C® Cell Control

### Indications for Use:

5C Cell Control is a hematology quality control material used to monitor the performance of COULTER hematology analyzers listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents (Refer to your Product Manuals or On-line Help System.)

The assigned values and expected ranges on the TABLE OF EXPECTED RESULTS can be used to monitor instrument performance. This product can also be used to establish your own laboratory mean.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use
Optional Format 1-2-96

Division Sign Off

Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K060464

Concurrence of CDRH, Office of Device Evaluation (ODE)