(41 days)
The CDS Hematology Calibrator for red cell, white cell and platelet counting is a device that resembles red cells, white cells and platelets in whole blood specimens and is intended to serve as a calibration standard for automated hematology analyzers, including Beckman Coulter: S-Plus IV-VI series, STKR, JS, JR, ST and JT series, STKS, MAXM, MD, Counto, OnyX, T series and A . T and A . T diff series analyzers; the Abbott Cell-Dyn 1100, Cell-Dyn 1400, 1500, 1600 and 1700 analyzers; and the Danam EXCEL 16 and EXCEL 22 and Coulter Ac T diff analyzers used to count red cells, white cells and platelets. It is a stable suspension of particles whose size, shape, concentration and other characteristics have been precisely and accurately determined.
Not Found
This document is a 510(k) premarket notification decision letter from the FDA for the CDS Hematology Calibrator (CDS CAL). It states that the device is substantially equivalent to legally marketed predicate devices, meaning it can be marketed. However, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it include details about performance, sample size, ground truth, or expert qualifications.
Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory approval based on "substantial equivalence" rather than detailed performance metrics and studies.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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JUN 1 0 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Andrew C. Swanson President Clinical Diagnostic Solutions, Inc. 1660 N.W. 65th Avenue Suite 2 Plantation, FL 33313
K041130 Re:
Trade/Device Name: CDS Hematology Calibrator (CDS CAL) Regulation Number: 21 CFR 864.8165 Regulation Name: Calibrator for hemoglobin or hematocrit measurement Regulatory Class: Class II Product Code: KRZ, KRY, KSA Dated: March 29, 2004 Received: May 4, 2004
Dear Mr. Swanson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beeemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the entributions of the enactment date of the Medical Device Amendments, or to conimer of the rias 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 r ou may, therefore, marris 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 it may be subject to Sach additions (CFR), Parts 800 to 895. In additions (CFR), Parts 800 to 895 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 I Tcase be advised that I Driv issualite or our device complies with other requirements of the Act that I Dri has intatutes and regulations administered by other Federal agencies. You must or any I coclar statutes and regaraments, 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) I mis letter will and in you to begin finding of substantial equivalence of your device to a legally promated 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, rs you don't op 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). You may obtain other general information on your responsibilities under the Act from the I va inay 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,
Joseph L. Hackett
Joseph L. Hackett, Ph.D. Acting 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: K041130
Device Name: _CDS Hematology Calibrator (CDS CAL)
Indications for Use:
The CDS Hematology Calibrator for red cell, white cell and platelet counting is a device The CDS Hematores] Canceaves and platelets in whole blood specimens and is that tescholes red contry with eent and for automated hematology analyzers, including
intended to serve as a calibration standard for automation and comparent and MM michded to Serve as a valle-VI series, STKR, JS, JR, ST and JT series, STKS, MAXM, Deckinal: Counto, OnyX, T series and A . T and A . T diff series analyzers; the 1101, Gell-Dyn 1400, 1500, 1600 and 1700 and 1700 analyzers; and the Danam EXCEL 16 and About Cen Dyn 1100) wood to count red cells, white cells and platelets. It is a EACEL 22 andry 2015, micenable to ose size, shape, concentration and other characteristics have been precisely and accurately determined.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K041130
Page 1 of 1 __
§ 864.8165 Calibrator for hemoglobin or hematocrit measurement.
(a)
Identification. A calibrator for hemoglobin or hematocrit measurement is a device that approximates whole blood, red blood cells, or a hemoglobin derivative and that is used to set instruments intended to measure hemoglobin, the hematocrit, or both. It is a material whose characteristics have been precisely and accurately determined.(b)
Classification. Class II (special controls). 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.