K Number
K092505
Device Name
BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203
Date Cleared
2009-12-11

(119 days)

Product Code
Regulation Number
866.5340
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
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More Information

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No
The document describes a reagent for a clinical chemistry analyzer, which is a laboratory test for measuring a specific substance (ferritin) in blood. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.

No.
The device is an in vitro diagnostic reagent used to measure ferritin levels, aiding in the diagnosis of iron metabolism diseases, rather than directly treating or preventing them.

Yes
The text explicitly states "For in vitro diagnostic use only" and "Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism."

No

The device is a reagent for use with a clinical chemistry analyzer, indicating it is a chemical substance and not a software-only device.

Yes, this device is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section explicitly states:

  • "For in vitro diagnostic use only." This is a clear declaration that the device is intended for use outside of the body to diagnose conditions.
  • "The Ferritin Reagent is for the determination of ferritin concentrations in human serum and plasma..." This describes the specific biological samples (serum and plasma) and the analyte (ferritin) being measured, which are typical for in vitro diagnostics.
  • "Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism..." This explains the diagnostic purpose of the measurement, further confirming its IVD nature.

N/A

Intended Use / Indications 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.

Product codes

DBF

Device Description

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Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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Predicate Device(s)

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Reference Device(s)

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Predetermined Change Control Plan (PCCP) - All Relevant Information

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§ 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).

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus symbol.

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

Image /page/0/Picture/6 description: The image shows the text "Re: k092 Trad". The text is in a simple, sans-serif font. The letters are black, and the background is white. The text is slightly blurry, but it is still legible.

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

1

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

2

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