R&D CBC-XE HEMATOLOGY CONTROL

K042094 · R&D Systems, Inc. · JPK · Sep 1, 2004 · Hematology

Device Facts

• Record ID: K042094
• Device Name: R&D CBC-XE HEMATOLOGY CONTROL
• Applicant: R&D Systems, Inc.
• Product Code: JPK · Hematology
• Decision Date: Sep 1, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

R&D CBC-XE Hematology Control is a tri-level control designed for use in monitoring the accuracy and precision of Sysmex™ hematology instruments. Refer to the assay sheet for specific instrument models.

Device Story

R&D CBC-XE Hematology Control is a tri-level control mixture used to monitor the performance of Sysmex hematology instruments. It serves as a quality control tool for laboratory professionals to verify instrument accuracy and precision. The control is processed by the hematology instrument similarly to a patient sample; the instrument measures the control and provides output values for various hematology parameters. Clinicians and laboratory staff compare these output values against established assay ranges provided in the product documentation. If the results fall within the expected range, the instrument is considered to be performing correctly, ensuring reliable patient test results. The control is stored at 2-8°C and has a shelf life of 75 days (closed) or 14 days/14 samplings (open).

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements; results met predetermined acceptance criteria.

Technological Characteristics

Tri-level hematology control mixture. Designed for use with Sysmex hematology instruments. Stability: 75 days closed vial, 14 days/14 samplings open vial at 2-8°C. No specific materials of construction or software algorithms described.

Indications for Use

Indicated for use as a tri-level quality control material to monitor the accuracy and precision of Sysmex hematology instruments in a clinical laboratory setting.

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.

Submission Summary (Full Text)

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K042094

## 510(k) Summary R&D Systems, Inc. CBC-XE Hematology Control

| Date of Summary: | July 30, 2004 |
|----------------------|-----------------------------------------------------------------------|
| Company Name: | R&D Systems, Inc.<br>614 McKinley Place N.E.<br>Minneapolis, MN 55413 |
| Contact name: | Ralph E. Hogancamp<br>612-656-4413, FAX [phone] |
| Classification name: | Hematology Quality Control Mixture |
| Product name: | R&D CBC-XE Hematology Control |
| CFR section: | 864.8625 Hematology quality control<br>mixture. |
| Device Class: | Class II |

Predicate Device: R&D Systems CBC-8K Hematology Control, K913879 manufactured by R&D Systems, Inc. 614 McKinley Place N.F., Minneapolis, MN 55413

Description: This control is a hematology control mixture designed to monitor values obtained from Sysmex hematology instruments.

Intended use: R&D CBC-XF Hematology Control is a tri-level control designed for use in monitoring the accuracy and precision of Sysmex™ hematology instruments. Refer to the assay sheet for specific instrument models.

Comparison: Both products are used to monitor Sysmex™ hematology instruments. The R&D CBC-XE added new parameters.

Discussion: Laboratory testing of 3 validation lots has shown R&D CBC-XE Hematology Control to have substantial equavalence in performance, precision and stability to the predicate device. R&D CBC-XE Hematology Control passed the acceptance criteria of remaining within the assay range over the life of the product. R&D CBC-XE Hematology Control has demonstrated precision as indicated by the small standard deviation and % CV's obtained during laboratory testing. Expiriation dating has been established at 75 days (closed vial) and 14 days, or 14 samplings (open vial) when stored at 2 - 8° C and handled according to instructons for use.

Conclusion: R&D CBC-XE Hematology Control is a safe and effective control for the above intended use when used as instructed in the package insert.

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Image /page/1/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. 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

Mr. Ralph E. Hogancamp Quality Assurance and Regulatory Affairs Specialist R & D Systems, Inc. 614 McKinley Place, N.E. Minneapolis, Minnesota 55413

k042094 Re:

Trade/Device Name: R & D CBC-XE Hematology Control Regulation Number: 21 CFR § 864.8625 Regulation Name: Hematology Quality Control Mixture Regulatory Class: II Product Code: JPK Dated: July 20, 2004 Received: August 5, 2004

Dear Mr. Hogancamp:

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 rcclassified 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.

SEP - 1 2004

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 Eederal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has madc 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 cquivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to procced 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/dsma/dsmamain.html.

Sincerely yours,

Robert L. Becker Jr.

Robert L. Becker, Jr., M.D., 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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## Indications for Use

## 510(k) Number (if known): K042094

Device Name: R&D CBC-XE Hematology Control

Indications for Use:

्

R&D CBC-XE Hematology Control is a tri-level control designed for use in monitoring the accuracy and precision of Sysmex™ hematology instruments. Refer to assay sheet for specific instrument models.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Josephine Bautista

Division Sign-Off

os of In Vitro Diagnostic Device ﺎ ﺳﺎﺗ Instantion and Seiny

510(k) K042094

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