BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203

K092505 · Beckman Coulter, Inc. · DBF · Dec 11, 2009 · Immunology

Device Facts

• Record ID: K092505
• Device Name: BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203
• Applicant: Beckman Coulter, Inc.
• Product Code: DBF · Immunology
• Decision Date: Dec 11, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5340
• Device Class: Class 2

Intended Use

The Ferritin Reagent is for the determination of ferritin concentrations in human serum and plasma on the Beckman Coulter family of clinical chemistry analyzers. 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.

Device Story

In vitro diagnostic reagent for quantitative ferritin measurement in human serum and plasma; utilizes latex-enhanced immuno-turbidimetric assay principle; antibody-coated latex beads aggregate in presence of ferritin antigen; immune complexes scatter light; turbidimeter measures light scatter proportional to ferritin concentration; used on Beckman Coulter AU series clinical chemistry analyzers; operated by laboratory technicians; output provided as concentration (ng/mL); results assist clinicians in diagnosing iron metabolism disorders; benefits include assessment of body iron stores and correlation with bone marrow iron.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on the device's performance as an immunological test system for ferritin.

Technological Characteristics

Latex-enhanced immuno-turbidimetric assay; liquid ready-to-use reagent; compatible with Beckman Coulter AU400/480/640/680/2700/5400 analyzers; standardized to 3rd International Standard for Ferritin (NIBSC 94/572); utilizes photo-optic detection of light scatter; reagent stability 60 days on-board.

Indications for Use

Indicated for the quantitative determination of ferritin in human serum and plasma to aid in the diagnosis of iron metabolism disorders, including hemochromatosis and iron deficiency anemia, in adult patients.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone] or [phone] 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