CD-CHEX PLUS BC

K051633 · Streck · GGL · Aug 16, 2005 · Hematology

Device Facts

• Record ID: K051633
• Device Name: CD-CHEX PLUS BC
• Applicant: Streck
• Product Code: GGL · Hematology
• Decision Date: Aug 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

CD-Chex® Plus BC is designed to serve as a quality control specimen for clinical flow cytometric procedures performed with Beckman Coulter flow cytometry instruments.

Device Story

CD-Chex® Plus BC is a stabilized human blood cell suspension (red and white blood cells) used as a quality control material for clinical flow cytometry. It is intended for use in clinical laboratories performing flow cytometric analysis on Beckman Coulter instruments. The device contains surface antigens that react with monoclonal antibodies, allowing for the identification of leukocyte subsets (lymphocytes, monocytes, granulocytes) based on light scatter and antigen expression. Laboratory personnel use the product to verify instrument performance and assay consistency by comparing recovery values against assigned assay means. It provides a reference for normal peripheral blood leukocytes, helping ensure the accuracy of clinical diagnostic testing.

Clinical Evidence

No clinical data. Bench testing only. Stability was validated using Beckman Coulter EPICS XL flow cytometers with tetraONE and System II software. Testing included closed-vial stability (up to 60 days) and open-vial stability (up to 30 days) across multiple lots. Alternate site testing at four laboratories confirmed consistency of assigned values.

Technological Characteristics

Suspension of stabilized human red and white blood cells in a preservative medium. Packaged in 3.0ml plastic vials. Designed for use with Beckman Coulter flow cytometry instruments. Analyzed via light scatter and fluorescent antibody staining for leukocyte subset identification.

Indications for Use

Indicated for use as a quality control specimen for clinical flow-cytometric procedures performed with Beckman Coulter flow cytometry instruments.

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

• CD-Chex® Plus (K960894)

Submission Summary (Full Text)

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K051633

# 510(k) Summary of Safety and Effectiveness

| 510(k) Submitter: | Streck<br>7002 South 109th Street<br>La Vista, NE 68128 |
|---------------------------------|-------------------------------------------------------------|
| Official Correspondent: | Carol Thompson, Quality Assurance Manager<br>[phone] |
| Date Prepared: | July 15, 2005 |
| Names of Device:<br>Trade Name: | CD-Chex® Plus BC |
| Common Name: | Immunophenotyping Control |
| Classification Name: | White Cell Control, 21CFR864.8625 |
| Predicate Device: | CD-Chex® Plus (K960894) |

Description: CD-Chex Plus BC is a suspension of stabilized human red blood cells and human white blood cells packaged in a plastic vial containing 3.0 mL volumes. The vials are packaged in a vacuum formed "clam-shell" box.

### Intended Use:

CD-Chex Plus BC is designed to serve as a quality control specimen for clinical flowcytometric procedures performed with Beckman Coulte® flow cytometry instruments.

### Comparison with Predicate Device:

Like CD-Chex Plus, CD-Chex Plus BC is intended to enable the user to verify satisfactory performance of flow cytometry systems. Both devices contain control cells which possess surface antigens detectable with monoclonal antibodies.

Unlike CD-Chex Plus, CD-Chex Plus BC has a shorter closed vial stability. CD-Chex Plus BC closed vial stability is 60 days, where CD-Chex Plus is 90 days. The other difference is that CD-Chex Plus BC has two components that are used generally for stabilizing cellular components that are at a higher concentration than CD-Chex Plus. This allows the product to work optimally with Coulter and BC FACSCount flow cytometry systems.

### Testing Performed:

Three studies of CD-Chex Plus BC were conducted: 1) Closed Vial Stability; 2) Open Vial Stability; and 3) Alternate Site Testing. Study results showed CD-Chex Plus BC to be consistently reproducible and stable for the entire product dating.

### Conclusions Drawn from the Tests:

Study results show CD-Chex Plus BC to be consistently reproducible, substantially equivalent to the predicate product, and stable for the entire product dating. CD-Chex Plus BC is a safe and effective product, which fulfills its intended use when used as instructed in the product package insert.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines representing the feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carol Thompson Quality Assurance Manager Streck 7002 South 109th Street La Vista, Nebraska 68128

AUG 1 6 2005

Re: k051633 Trade/Device Name: CD-Chex® Plus BC Regulation Number: 21 CFR § 864.8625 Regulation Name: Hematology Quality Control Regulatory Class: II Product Code: GGL Dated: July 21, 2005 Received: July 22, 2005

## Dear Ms. Thompson:

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 (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.

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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,

lobetz Beckerh

Robert L. Becker, Jr., MD, PH.1 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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510(k) Number (if known):

K05 No33

CD-Chex® Plus BC Device Name:

Indications For Use:

CD-Chex Plus BC is designed to serve as a quality control specimen for clinical flow-cytometric procedures performed with Beckman Coulter® flow cytometry instruments.

Prescription Use X (Per 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)

Il Reeves for J. Bautista
Division Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K051632