R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL

K051339 · R&D Systems, Inc. · JPK · Jul 12, 2005 · Hematology

Device Facts

• Record ID: K051339
• Device Name: R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL
• Applicant: R&D Systems, Inc.
• Product Code: JPK · Hematology
• Decision Date: Jul 12, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

R&D CBC-4K Plus Retics Hematology Control is an assayed whole blood control designed to monitoring the accuracy and precision of CELL-DYN® hematology instruments. Refer to assay sheet for specific instrument models.

Device Story

Modified hematology control device; addition of new parameters: RETC (reticulocyte count), % RETC, and IRF (immature reticulocyte fraction); includes porcine reticulocytes in control formulation. Used in clinical laboratory settings to verify performance of hematology analyzers. Device modification maintains fundamental scientific technology of previously cleared device.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements to confirm performance of new parameters.

Technological Characteristics

Hematology control containing porcine reticulocytes; parameters include RETC, % RETC, and IRF. Device is a modification of a previously cleared hematology control.

Indications for Use

Indicated for use as an assayed whole blood control to monitor the accuracy and precision of CELL-DYN® 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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JUL 1 2 2005

#### 510(k) Special Summary R&D Systems, Inc. CBC-4K Plus Retics Hematology Control

| Date of Summary: | June 29, 2005 |
|----------------------|-----------------------------------------------------------------------|
| 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-4K Plus Retics Hematolog<br>Control |
| CFR section: | 864.8625 Hematology quality control<br>mixture. |

Predicate Device: R&D Systems CBC-4K Hematology Control, K970331 manufactured by R&D Systems, Inc. 614 McKinley Place N.E., Minneapolis, MN 55413

Description: This control is an assayed whole blood control designed to monitor values on multi-parameter hematology cell counters.

Intended use: R&D CBC-4K Plus Retics Hematology Control is an assayed whole blood control designed to monitoring the accuracy and precision of CELL-DYN® hematology instruments. Refer to assay sheet for specific instrument models.

Comparison: Both products are used to monitor CELL-DYN® hematology instruments. The R&D CBC-4K Plus Retics added new parameters.

Discussion: Laboratory testing of 3 validation lots has shown R&D CBC-4K Plus Retics Hematology Control to have substantial equavalence in performance, precision and stability to the predicate device. R&D CBC-4K Plus Retics Hematology Control passed the acceptance criteria of remaining within the assay range over the life of the product, R&D CBC-4K Plus Retics 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 8 days (open vial) when stored at 2 - 8° C and handled according to instructons for use.

Conclusion: R&D CBC-4K Plus Retics 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 & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.

Public Health Service

# JUL 1 2 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k051339

Trade/Device Name: R&D CBC-4K Plus Retics Hematology Control Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: JPK Dated: June 29, 2005 Received: June30, 2005

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,

lobetz Beckerh

Robert L. Becker, Jr., MD, PH. 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): K051339

#### Device Name: R&D CBC-4K Plus Retics Hematology Control

Indications for Use:

R&D CBC-4K Plus Retics Hematology Control is an assayed whole blood control designed to monitoring the accuracy and precision of CELL-DYN® hematology instruments. Refer to assay sheet for specific instrument models.

Prescription Use X________AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K05133 510(k)________________________________________________________________________________________________________________________________________________________________________

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