(119 days)
The Ferritin Reagent is for the determination of ferritin concentrations in human serum and plasma on the Beckman Coulter family of AU clinical chemistry analyzers. For in vitro diagnostic use only.
Serum ferritin is an indicator of body iron stores: it has been shown to correlate with stainable bone marrow iron. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.
Not Found
This document is an FDA 510(k) clearance letter for the Beckman Coulter Ferritin Reagent (OSR61203). It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed study information, acceptance criteria, or performance data that you requested about the device.
The letter explicitly states: "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...". This means the FDA found sufficient evidence that the new device performs as intended and is as safe and effective as a device already on the market. The specific details of how that substantial equivalence was demonstrated are typically found in the 510(k) submission itself, which is not provided in this public clearance letter.
Therefore, I cannot answer your questions based solely on the provided text. The document is primarily a formal notification of clearance, not a technical report of the studies performed.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center-WO66-G609 Silver Spring, MD 20993-0002
Beckman Coulter Inc. c/o Ms. Catriona Neilan Regulatory Affairs Manager Lismeehan, O'Callaghan's Mills Co. Clare Ireland
DEC 1 1 2009
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Re: K092505
Trade/Device Name: Ferritin (OSR61203) Regulation Number: 21 CFR §866.5340 Regulation Name: Ferritin immunological test system Regulatory Class: Class II Product Code: DBF Dated: October 27, 2009 Received: October 28, 2009
Dear Ms. Neilan:
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 (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 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); medical device reporting (reporting of medical
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Page 2 - Ms. Catriona Neilan
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
thova In Chan
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): K092505
Device Name: Beckman Coulter Ferritin Reagent (OSR61203)
Indication For Use:
The Ferritin Reagent is for the determination of ferritin concentrations in human serum and plasma on the Beckman Coulter family of AU clinical chemistry analyzers. For in vitro diagnostic use only.
Serum ferritin is an indicator of body iron stores: it has been shown to correlate with stainable bone marrow iron. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.
Prescription Use - V -(21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Reena Philip
Division Sian-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K092505
§ 866.5340 Ferritin immunological test system.
(a)
Identification. A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.(b)
Classification. Class II (performance standards).