COULTER 6C CELL CONTROL, MODELS 628027 & A59925

K081822 · Beckman Coulter, Inc. · JPK · Jan 21, 2009 · Hematology

Device Facts

• Record ID: K081822
• Device Name: COULTER 6C CELL CONTROL, MODELS 628027 & A59925
• Applicant: Beckman Coulter, Inc.
• Product Code: JPK · Hematology
• Decision Date: Jan 21, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

COULTER® 6C 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. 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

Hematology quality control material; stabilized human blood components; includes stabilized erythrocytes, platelet-sized components, and fixed erythrocytes simulating leukocytes and nucleated red blood cells (NRBCs). Used in clinical laboratories to monitor daily performance of automated hematology analyzers (UniCel® DxH 800). Three concentration levels provided. Laboratory personnel aspirate control material into analyzer; instrument performs counting, sizing, hemoglobin determination, and white blood cell differentiation using VCSn technology. Output compared against assigned values/expected ranges in provided tables to verify instrument accuracy and precision. Facilitates quality assurance and establishment of laboratory-specific means.

Clinical Evidence

No clinical data. Bench testing only. Precision and reproducibility evaluated across three lots and three levels of control material on the UniCel® DxH 800 analyzer. Stability testing (open and closed vial) confirmed 95-day closed vial stability and 18-event/16-day open vial stability. Value assignment process utilized validated systems and Beckman Coulter reagents.

Technological Characteristics

Stabilized human blood; contains stabilized erythrocytes, platelet-sized components, and fixed erythrocytes (leukocyte/NRBC analogs). Isotonic medium. Three concentration levels. Compatible with UniCel® DxH 800. VCSn technology used for sensing. Storage at 2-8°C. Closed vial stability 95 days; open vial stability 18 events/16 days.

Indications for Use

Indicated for use as a hematology quality control material to monitor the performance of specific COULTER hematology analyzers in clinical laboratory settings.

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)
• COULTER® PX Cell Control (K060464)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a circular graphic on the left and the company name on the right. The graphic is a black circle with two curved white lines inside. The company name is written in a bold, sans-serif font, with "BECKMAN" on top of "COULTER".

l

JAN 21 2009

# 510(k) Summary COULTER 6C Cell Control

# l Submitted By:

Lourdes Coba Staff Regulatory Affaırs Specialıst Beckman Coulter, Inc 11800 SW 147 Avenue, M/C 31-B06 Mıamı, Florıda 33196-2500 Telephone [phone] FAX [phone]

K081822

# 2 Date Submitted:

June 26, 2008

# 3 Device Name(s):

### 3 1 Proprietary Names

COULTER® 6C Cell Control

# 3 2 Classification Name

Hematology qualıty control mıxture (21 CFR § 864 8625)

#### 4 Predicate Device:

| Candidate(s) | Predicate | Manufacturer | Docket<br>Number |
|-----------------------------|-----------------------------------------------------------------------------|----------------------|-------------------------|
| COULTER® 6C Cell<br>Control | COULTER® 5C®<br>Cell Control<br>(Cleared as<br>COULTER® PX Cell<br>Control) | Beckman Coulter, Inc | K912133<br>&<br>K060464 |

{1}------------------------------------------------

### 5 Description:

.

て

6C Cell Control is a reference product prepared from treated, stabilized human erythrocytes in an isotonic medium 6C Cell Control also contains a stabilized, platelet-sized component, and fixed erythrocytes to simulate leukocytes and nucleated red blood cells By design, 6C Cell Control confirms and monitors instrument accuracy and precision performance by providing measurements for counting, sizing, hemoglobin determination, NRBC enumeration and White Blood Cell differentiation using VCSn technology

### 6 Intended Use:

6C 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

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 6C Cell Control is essentially identical to the current COULTER 5C Cell Control with the addition of 2 parameters NRBC% and NRBC# This control 1s for use with the UniCel® DxH 800 analyzer (pending 510(k) submission) An NRBC analog was added to the 5C control product formulation

### 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 6C Cell Control support the Beckman Coulter stability claims of 18 events within 16 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 implementung regulation 21 CFR 807 92

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Beckman Coulter, Inc c/o Ms Nancy Nadler Staff Regulatory Affairs Specialist 11800 SW 147" Avenue Miamı, FL 33196

JAN 21 2009

Re k081822

Trade/Device Name Coulter® 6C Cell Control Regulation Number 21 CFR 864 8625 Regulation Name Hematology Quality Control Mixture Regulatory Class Class II Product Code Dated January 05, 2009 Received January 06, 2009

Dear Ms Nadler

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 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 comples 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 (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

{3}------------------------------------------------

Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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) For questions regarding postmarket surveillance, please contact CDRH's Otfice of Surveillance and Biometric's (OSB's) Division of Postmarket Survey)lance at [phone] For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone] 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 us Internet address http //www fda gov/cdrh/industry/support/index.html

Sincerely yours,

M chan

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

Enclosure

{4}------------------------------------------------

510(k) Number (if known) K

ીસ જિલ્લામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપા

Device Name COULTER® 6C Ccll Control

Indications For Use

6C Cell Control is a hematology quality control material used to monitor the performance of COULTER hematology analyzers Insted in 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 montor instrument performance This product can also be used to establish your own laboratory mean

Prescription Use __X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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

Concurrence of CDRH Office of In Vitro Diagnostic Devices (OIVD)
ision Sign Off
Office of In Vitro Diagnostic Design
Page 1 of

Office of In Vitro Diagnostic Device Evaluation and Sa

5.19(k) K081822

COULTER® 6C Cell Control Traditional 510(k) Notification

Page 14

Page 1 of 1