CDS 3-PD HEMATOLOGY CONTROLS

K024173 · Clinical Diagnostic Solutions, Inc. · JPK · Jan 14, 2003 · Hematology

Device Facts

• Record ID: K024173
• Device Name: CDS 3-PD HEMATOLOGY CONTROLS
• Applicant: Clinical Diagnostic Solutions, Inc.
• Product Code: JPK · Hematology
• Decision Date: Jan 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

CDS 3-PD Hematology Controls are intended to scrvc as a mcans of verifying the results obtained from a hematology analyzer system. This material applies to hematology analyzer systems equipped to measure RBC count and size, WBC count and size, I'LT count and size, total HGB concentration, and calculated parameters HCT, MCH, MCHC, RDW, WBC percent and uumber for lymphocyte, monounclear and granulocyte populations. The products are designed to be sampled directly into the analyzer system as a sample specimen with minimal operator intervention.

Device Story

CDS 3-PD Hematology Controls are stabilized blood-based control materials used to verify the accuracy and precision of hematology analyzer systems. The product is sampled directly into the analyzer as a specimen, mimicking patient samples. It provides known values for RBC, WBC, and PLT counts/sizes, HGB concentration, and calculated indices (HCT, MCH, MCHC, RDW, and WBC differential). Used in clinical laboratory settings by laboratory personnel to monitor system performance and ensure reliable patient test results.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stabilized blood-based control material. Designed for direct aspiration by hematology analyzer systems. No electronic or software components.

Indications for Use

Indicated for use as a quality control material for hematology analyzer systems to verify performance in measuring RBC, WBC, PLT counts and sizes, HGB concentration, and derived parameters (HCT, MCH, MCHC, RDW, and WBC differential populations).

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

• Beckman Coulter 4C Plus
• Streck Para12
• Hematronix Figuinox 16
• R&D Systems CBC-3D

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 4 2003

Mr. Andrew C. Swanson President Clinical Diagnostic Solutions, Inc. 1660 N.W. 65th Avenue, Suite 2 Plantation, FL 33313

k024173 Re:

> Trade/Device Name: CDS 3-PD Hematology Controls Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: JPK Dated: December 2, 2002 Received: December 18, 2002

Dear Mr. Swanson:

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 vour 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).

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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.

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). 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 Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number: K024173

Device Name: CDS 3-PD Hematology Coultols

Indications for Use:

CDS 3-PD Hematology Controls are intended to scrvc as a mcans of verifying the results obtained from a hematology analyzer system. This material applies to hematology analyzer systems equipped to measure RBC count and size, WBC count and size, I'LT count and size, total HGB concentration, and calculated parameters HCT, MCH, MCHC, RDW, WBC percent and uumber for lymphocyte, monounclear and granulocyte populations. The products are designed to be sampled directly into the analyzer system as a sample specimen with minimal operator intervention.

These control products are substantially equivalent to control products of other manufacturers already in commercial distribution, such as Beckman Coulter 4C Plus, Streck Para12. Hematronix Figuinox 16 and R&D Systems CBC-3D hematology controls.

(PLEASE DO NOT WRITE DELOW THIS LINE-CONTINUE ON ANOTHER PAGE II? NEEDED)

Concurrence of CDRIL, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K024173

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)