(194 days)
The MS 4/5 is a quantitative, automated hematology analyzer that provides a leukocyte differential for in vitro diagnostic use in clinical laboratories.
Not Found
The provided texts are from a 510(k) premarket notification for the MS 4/5 Hematology Analyzer, primarily containing the FDA's response and the Indications for Use statement. It does not contain the detailed acceptance criteria and study information that would typically be found in the manufacturer's submission for device performance.
Therefore, I cannot provide the requested information from these documents. To answer your questions, I would need the actual study report or the sections of the 510(k) submission that detail the performance testing and acceptance criteria for the MS 4/5 Hematology Analyzer.
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AUG 3 1 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Jackie Coleman, Ph.D. Director of Scientific and Regulatory Affairs Melet Schloesing Laboratories USA 2030 Gillepsie Way, Suite 104 El Cajon, California 92020
K050421 Re:
Trade/Device Name: MS 4/5 Hematology Analyzer Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: July 20, 2005 Received: July 27, 2005
Dear Dr. Coleman:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your be determined 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 encrease) (o togethy) in the Medical Device Amendments, or to commerce prior to May 20, 1978, are excordance with the provisions of the Federal Food, DNA de vices that have been require approval of a premarket approval application (PMA). and Costicule I for (110) that as noves, subject to the general controls provisions of the Act. The 1 ou may, mercrore, maines of the Act include requirements for annual registration, listing of general controls provisions 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 IT your device is classified (600 a00 voy ols. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations a hiar oc saily of to care addin and Federal Regulations (CFR), Parts 800 to 895. In addition, FDA be found in Thre 21, Oous of a sents 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 that I DA has made a acterine administered by other Federal agencies. You must or any I catales and registments, including, but not limited to: registration and listing (21 Comply with an the Free brequire Parts 801 and 809); and good manufacturing practice CI K Pat 607), adoming (21 be quality systems (QS) regulation (21 CFR Part 820). This letter requirements as becament are ag your device as described in your Section 510(k) premarket win anow you to begin marketing of substantial equivalence of your device to a legally marketed nonitication. The I Drivination 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 you destro specific introllion and advertising of your device, please contact the Office of In of quotions on are promise Evaluation and Safety at (240) 276-0484. 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 Tou may obatin other gefarers, 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/industry/support/index.html
Sincerely yours,
Robert Beckerh
Robert L. Becker, Jr., MD, PA 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): Da50
Device Name: MS 4/5 Hematology Analyzer
Indications for Use:
The MS 4/5 is a quantitative, automated hematology analyzer that provides a leukocyte THE MO 4/513 a quantitulive, cannostic use in clinical laboratories.
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 Device Evaluation (ODE)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K050421
Page 18 of 165
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”