R&D LH-NRBC HEMATOLOGY CONTROL

K061320 · R&D Systems, Inc. · JPK · Jun 2, 2006 · Hematology

Device Facts

• Record ID: K061320
• Device Name: R&D LH-NRBC HEMATOLOGY CONTROL
• Applicant: R&D Systems, Inc.
• Product Code: JPK · Hematology
• Decision Date: Jun 2, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

R&D LH-nRBC Hematology Control is a tri-level control for use in monitoring the performance of Coulter® hematology instruments and other auxiliary methods. Refer to assay sheet for specific instrument models.

Device Story

Tri-level hematology control; used to monitor performance of Coulter® hematology instruments and auxiliary methods. Product serves as reference material to verify instrument accuracy and precision. Laboratory personnel use control to ensure hematology analyzers remain within established assay ranges. Stability established at 75 days (closed vial) and 14 days (open vial) at 2-8°C.

Clinical Evidence

Bench testing only. Validation performed on 3 lots to assess performance, precision, and stability. Results confirmed device remains within assay range over product life. Precision demonstrated via small standard deviation and % CVs.

Technological Characteristics

Tri-level hematology control mixture. Liquid form factor. Designed for use with Coulter® hematology instruments. Stability: 75 days closed vial, 14 days open vial at 2-8°C.

Indications for Use

Indicated for use as a tri-level quality control material to monitor the performance of Coulter® hematology instruments and auxiliary methods.

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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JUN - 2 2006

Lo61320

### 510(k) Special Summary R&D Systems, Inc. LH-nRBC Hematology Control

| Date of Summary: | May 10, 2006 |
|----------------------|-----------------------------------------------------------------------|
| 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 LH-nRBC Hematology Control |
| CFR section: | 864.8625 Hematology quality control<br>mixture. |
| Device Class: | Class II |

Predicate Device: R&D Systems CBC-5D Hematology Control, K983032 manufactured by R&D Systems, Inc. 614 McKinley Place N.E., Minneapolis, MN 55413

Description: This control is a tri-level control for use in monitoring the performance of Coulter® hematology instruments and other auxiliary methods.

Intended use: R&D LH-nRBC Hematology Control is a tri-level control for useain monitoring the performance of Coulter® hematology instruments and other auxiliary methods. Refer to assay sheet for specific instrument models.

Comparison: Both products are used to monitor Coulter® multi-parameter hematology instruments. The R&D LH-nRBC added new parameters.

Discussion: Laboratory testing of 3 validation lots has shown R&D LH-nRBC Hematology Control to have substantial equavalence in performance, precision and stability to the predicate device. R&D LH-nRBC Hematology Control passed the acceptance criteria of remaining within the assay range over the life of the product. R&D LH-nRBC 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 (open vial) when stored at 2 - 8° C and handled according to instructons for use.

Conclusion: R&D LH-nRBC 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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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Ralph E. Hogancamp Regulatory Affairs R & D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413

JUN - 2 2006

Re: k061320 Trade/Device Name: R&D LH-nRBC Hematology Control Regulation Number: 21 CFR § 864.8625 Regulation Name: Hematology Quality Control Mixture Regulatory Class: II Product Code: JPK Dated: May 10, 2006 Received: May 16, 2006

Dear 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 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,

Robert L. Becker Jr.

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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# Indications for Use

# 510(k) Number (if known): K 00/ 320

# Device Name: R&D LH-nRBC Hematology Control

### Indications for Use:

R&D LH-nRBC Hematology Control is a tri-level control for use in monitoring the performance of Coulter® hematology instruments and other auxiliary methods. Refer to assay sheet for specific instrument models.

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=0

Office of In Vitro Diagnostic Device Evaluation and Safety

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