R&D CBC-3D + CRP HEMATOLOGY CONTROL

K061511 · R&D Systems, Inc. · JPK · Jul 10, 2006 · Hematology

Device Facts

• Record ID: K061511
• Device Name: R&D CBC-3D + CRP HEMATOLOGY CONTROL
• Applicant: R&D Systems, Inc.
• Product Code: JPK · Hematology
• Decision Date: Jul 10, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

R&D CBC-3D + CRP Hematology Control is a tri-level control to monitor values on automated and semi-automated impedence type hematology analyzers. It can also be used for manual methods.Refer to assay sheet for specific instrument models.

Device Story

R&D CBC-3D + CRP is a hematology control; used to monitor performance of hematology analyzers. Modification involves addition of C-Reactive Protein (CRP) component and updated assay sheet parameters. Device functions as a reference material to verify analyzer accuracy/precision. Used in clinical laboratory settings by laboratory technicians. Output provides expected values for hematology parameters; assists clinicians in validating instrument performance and ensuring reliable patient test results.

Clinical Evidence

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

Technological Characteristics

Tri-level hematology quality control mixture. Designed for impedance-based hematology analyzers. Stability: 105 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 performance of automated and semi-automated impedance-based hematology analyzers and manual hematology 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.

Predicate Devices

• R&D Systems CBC-3D Hematology Control (K843962)

Submission Summary (Full Text)

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## JUL 1 0 2006

#### 510(k) Special Summary R&D Systems, Inc. CBC-3D + CRP Hematology Control

| Date of Summary: | May 30, 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 CBC-3D + CRP Hematology Control |
| CFR section: | 864.8625 Hematology quality control<br>mixture. |
| Device Class: | Class II |

Predicate Device: R&D Systems CBC-3D Hematology Control, K843962 manufactured by R&D Systems, Inc. 614 McKinley Place N.E., Minneapolis, MN 55413

Description: This control is a tri-level control to monitor values on automated and semiautomated impedence type hematology analyzers. It can also be used for manual methods.

Intended use: R&D CBC-3D + CRP Hematology Control is a tri-level control to monitor values on automated and semi-automated impedence type hematology analyzers. It can also be used for manual methods.Refer to assay sheet for specific instrument models.

Comparison: Both products are used to monitor automated and semi-automated inpedence type hematology instruments. The R&D CBC-3D + CRP added a new parameter.

Discussion: Laboratory testing of 3 validation lots has shown R&D CBC-3D + CRP Hematology Control to have substantial equavalence in performance, precision and stability to the predicate device. R&D CBC-3D + CRP Hematology Control passed the acceptance criteria of remaining within the assay range over the life of the product. R&D CBC-3D + CRP 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 105 days (closed vial) and 14 days (open vial) when stored at 2 - 8° C and handled according to instructons for use.

Conclusion: R&D CBC-3D + CRP 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

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Public Health Service

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

JUL 1 0 2006

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Re: k061511

> 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: June 28, 2006 Received: June 29, 2006

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 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,

lobatz Beckerh

Robert L. Becker, Jr., MD, P2 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 0615 | | L K

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

Indications for Use:

R&D CBC-3D + CRP Hematology Control is a tri-level control designed to monitor values on automated and semi-automated impedance type hematology analyzers. Refer to assay sheet for specific instrument models.

Over-The-Counter Use Prescription Use X (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Josephine Bautista

Division Sign Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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