COULTER 4C-EX 300 CELL CONTROL

K100607 · Beckman Coulter, Inc. · JPK · Nov 18, 2010 · Hematology

Device Facts

• Record ID: K100607
• Device Name: COULTER 4C-EX 300 CELL CONTROL
• Applicant: Beckman Coulter, Inc.
• Product Code: JPK · Hematology
• Decision Date: Nov 18, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

4C®-EX 300 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 instrument specific instructions for use). 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.

Device Story

4C®-EX 300 Cell Control is a stabilized human blood-based quality control mixture; contains treated erythrocytes, platelet-sized components, and fixed erythrocytes simulating leukocytes. Used in clinical laboratories to monitor daily performance of automated hematology analyzers (DxH™ 300/300C). Provided in three levels (Abnormal Low, Normal, Abnormal High). Laboratory personnel run the control through the analyzer; instrument measures counting, sizing, and hemoglobin determination. Output is compared against assigned values and expected ranges provided in the Table of Expected Results. Monitoring ensures instrument accuracy and precision; allows laboratories to establish their own mean. Benefits include verification of system performance and reliability of patient test results.

Clinical Evidence

No clinical data. Bench testing only. Precision/reproducibility studies were conducted on DxH 300 and DxH 300C analyzers across three sites over 20 days, following CLSI EP05-A2. Results met all pre-defined acceptance criteria for CV% across all levels (Abnormal Low, Normal, Abnormal High). Stability studies (open and closed vial) confirmed performance over the claimed shelf life.

Technological Characteristics

Stabilized human blood-based mixture; contains treated erythrocytes, stabilized platelet-sized components, and fixed erythrocytes. Liquid, ready-to-use reagent. Three levels of concentration. Analyzed via automated cell/differential counters using counting, sizing, and hemoglobin determination principles. Storage at 2-8°C. Open vial stability: 35 days/20 events; Closed vial stability: 145 days.

Indications for Use

Indicated for use as a hematology quality control material to monitor the performance of specific COULTER hematology analyzers and to establish laboratory means.

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® 4C®-ES Cell Control (k010064)

Submission Summary (Full Text)

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## 510(k) Summary COULTER® 4C®- EX 300 Cell Control

100007

#### 1. Submitted By:

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

NOV 1882010

#### 2. Date Submitted :

March 2, 2010

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

#### 3.1 Proprietary Names

COULTER® 4C®-EX 300 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® 4C®-EX 300<br>Cell Control<br>(with additional parameter,<br>RDW-SD) | COULTER® 4C®-ES<br>Cell Control | Beckman Coulter,<br>Inc. | K010064 |

#### 5. Description:

4C -EX 300 Cell Control is a reference product prepared from treated, stabilized human erythrocytes in an isotonic medium. 4C®-EX 300 Cell Control also contains a stabilized, platelet-sized component, and fixed erythrocytes to simulate leukocytes. By design, 4C®-EX 300 Cell Control confirms and monitors instrument accuracy and precision performance by providing measurements for counting, sizing and hemoglobin determination.

Traditional 510(k) Submission 4C-EX 300 Cell Control Beckman Coulter, Inc.

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#### ଚ. Intended Use:

4C -EX 300 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 instrument specific instructions for use)

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® 4C®-EX 300 Cell Control with the additional parameter (RDW-SD) is identical to the current COULTER 4C®-ES Cell Control. RDW-SD is a derived parameter from the RBC histogram which is obtained on a new COULTER® hematology analyzer. The control product formulation and manufacturing processes were not modified to obtain the additional parameter.

#### 8. Summary of Performance Data:

| Study | Study Design | Study Results |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Open and<br>Closed Vial<br>Stability | Evaluated open and closed vial stability<br>of 3 lots of 4C®-EX 300 Cell Control over<br>the shelf life of the product on a DxH 300<br>and DxH 300C. | 4C®-EX 300 Cell<br>Control demonstrated<br>acceptable results. |
| Value<br>Assignment<br>Process | Value assignments for each lot of 4C®-<br>EX 300 Cell Control are determined on<br>validated systems using specific<br>Beckman Coulter reagents. Assigned<br>Values are confirmed by multiple<br>analysis of the control product. | Established process for<br>generating assigned<br>value for 4C®-EX 300<br>Cell Control. |
| Range<br>Determination<br>Process | The expected ranges for RDW-SD were<br>calculated by a bio-statistician based<br>upon the assigned values and expected<br>ranges of MCV and RDW parameters<br>and the mathematical relationship<br>between these parameters for each level<br>of 4C®-EX 300 Cell Control. | Established RDW-SD<br>expected ranges for<br>each level of 4C®-EX<br>300 Cell Control. |

Traditional 510(k) Submission 4C-EX 300 Cell Control Beckman Coulter, Inc.

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The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution.

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

Traditional 510(k) Submission 4C-EX 300 Cell Control Beckman Coulter, Inc.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

Beckman Coulter, Inc. c/o Ms. Lourdes Coba Staff Regulatory Affairs Specialist 11800 SW 147 Avenue MS 31 B06 Miami, FL 33196

NOV 1 8 2010

Re: k100607

Trade/Device Name: COULTER 4C-EX 300 Cell Control Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: JPK Dated: October 27, 2010 Received: October 28, 2010

Dear Ms. Coba:

- స

.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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice

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Page 2 -- Ms. Lourdes Coba

requirements as set forth in the quality systems (QS) 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

ia mchan

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indication for Use

NOV 1 8 2010

510(k) Number (if known): K100607

Device Name: COULTER® 4C®-EX 300 Cell Control

Indication For Use:

4C®EX 300 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 instrument specific instructions for use).

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.

Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Signature: Sender R. S. Li

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Ki00607