(27 days)
CDS 3-PD Hematology Controls are intended to serve as a means 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, PLT count and size, total HGB concentration, and calculated parameters HCT, MCH, MCHC, RDW, WBC percent and number for lymphocyte, mononuclear and granulocyte populations. The products are designed to be sampled directly into the analyzer system as a sample specimen with minimal operator intervention.
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The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for the "CDS 3-PD Hematology Controls" device. This letter indicates that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices.
However, the letter does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. The 510(k) pathway for medical device clearance primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria and detailed performance studies like a PMA (Premarket Approval) application would.
Therefore, I cannot extract the requested information from the provided text. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed scientific study demonstrating performance against specific acceptance criteria.
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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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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)
§ 864.8625 Hematology quality control mixture.
(a)
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).(b)
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.