R & D BODY FLUID CONTROL

K020229 · R&D Systems, Inc. · JPK · Feb 6, 2002 · Hematology

Device Facts

• Record ID: K020229
• Device Name: R & D BODY FLUID CONTROL
• Applicant: R&D Systems, Inc.
• Product Code: JPK · Hematology
• Decision Date: Feb 6, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

R&D BODY FLUID Control is used to monitor total cell counts performed manually using a hemocytometer to validate the quantitation of red and white cells in patient body fluid samples.

Device Story

R&D BODY FLUID Control is an assay control mixture consisting of WBCs and RBCs in a stabilizing medium. It simulates the morphology and count of cells found in human body fluids. The device is used in clinical laboratory settings by laboratory personnel to monitor the accuracy and precision of manual hemocytometer cell counting procedures. By processing the control alongside patient samples, clinicians validate the quantitation of red and white cells. This monitoring ensures the reliability of manual counting methods, supporting accurate clinical decision-making regarding patient body fluid analysis.

Clinical Evidence

Bench testing only. Validation of three lots demonstrated performance, precision, and stability. Precision metrics included small standard deviation and %CVs. Stability established at 14 weeks (closed vial) and 30 days/14 entries (open vial) at 2-8°C.

Technological Characteristics

Hematology quality control mixture containing stabilized WBCs and RBCs. Formulated to simulate body fluid cell morphology and counts. Designed for manual hemocytometer use. Storage requirements: 2-8°C.

Indications for Use

Indicated for use as a hematology quality control mixture to monitor manual hemocytometer total cell counts of red and white blood cells in patient body fluid samples.

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

• Spinalscopics Control (K970862)

Submission Summary (Full Text)

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K
K020229

## FEB 0 6 2002

## 510(k) Summary R&D Systems, Inc. BODY FLUID Control

| Date of Summary: | January 22, 2002 |
|----------------------|----------------------------------|
| Company Name: | R&D Systems, Inc. |
| | 614 McKinley Place N.E. |
| | Minneapolis, MN 55413 |
| Contact name: | Ralph E. Hogancamp |
| | 612-656-4413, FAX [phone] |
| Classification name: | White and Red Blood Cell Control |

R&D BODY FLUID Control 864.8625 Hematology quality control mixture. Class II

Device Class:

Product name:

CFR section:

Predicate Device: Spinalscopics Control, manufactured by Quantimetrix Corporation 2005 Manhattan Beach Boulevard, Redondo Beach, CA 90278-1205. 510(k) number: K970862.

Description: This control is an assay control mixture for hemocytometer counts. R&D BODY FLUID Control is composed of WBCs and RBCs in a stabilizing medium. R&D BODY FLUID Control simulates cells and body fluids in morphology and count.

Intended use: R&D BODY FLUID Control is used to monitor total cell counts performed manually using a hemocytometer to validate the quantitation of red and white cells in patient body fluid samples.

Comparison: Both products are used with manual hemocytometer methods to monitor total cell counts in patient body fluids.

Discussion: Laboratory testing of 3 validation lots have shown R&D BODY FLUID Control to have substantial equavalence in performance, precision and stability to the predicate device. R&D BODY FLUID Control passed the acceptance criteria of remaining within the assay range over the life of the product. R&D BODY FLUID Control has demonstrated precision as indicated by the small standard deviation and %CV's obtained during laboratory testing. Expiriation dating has been established at 14 weeks in customers hands (closed vial) and 30 days, or 14 entries (open vial) when stored at 2 - 8° C and handled according to instructons for use.

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

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 0 6 2002

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

Re: k020229

Trade/Device Name: R&D BODY FLUID Control Regulation Number: 21 CFR § 864.8625 Regulation Name: Hematology QC Mixture Regulatory Class: II Product Code: JPK Dated: January 22, 2002 Received: January 23, 2002

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Koao229

Device Name: R&D BODY FLUID Control

Indications for Use:

R&D BODY FLUID Control is used to monitor total cell counts performed manually using a hemocytometer to validate the quantitation of red and white cells in patient body fluid samples.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

- (Division Sign-Off)
- Division of Clinical Laboratory Devices
- 510(k) Number KD20229

| <strong>Labels</strong> | <strong>Values</strong> |
|-------------------------|-------------------------|
| Prescription Use | ✓ |
| QR | |
| Over-The-CounterUse | |

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