K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET

K050944 · Kamiya Biomedical Co. · DBF · Dec 23, 2005 · Immunology

Device Facts

• Record ID: K050944
• Device Name: K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET
• Applicant: Kamiya Biomedical Co.
• Product Code: DBF · Immunology
• Decision Date: Dec 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5340
• Device Class: Class 2

Intended Use

The K-ASSAY® Ferritin (2) assay is an in vitro diagnostic reagent for the quantitative determination of ferritin (an iron-storing protein) in human serum and plasma by immunoturbidimetric assay on the Roche/Hitachi 917 analyzer. Measurements of ferritin aid in the diagnosis of diseases affecting iron overload and iron deficiency anemia. For in vitro diagnostic use. The K-ASSAY® Ferritin Calibrator Set is an in vitro diagnostic reagent for calibration of the K-ASSAY® Ferritin (2) Assay. For in vitro diagnostic use.

Device Story

K-ASSAY® Ferritin (2) is an in vitro diagnostic reagent kit for quantitative ferritin measurement in human serum/plasma. Input: patient serum or plasma samples. Principle: latex-enhanced immunoturbidimetric assay; sample mixed with reagent containing latex particles sensitized with rabbit anti-human ferritin antibody; agglutination occurs proportional to ferritin concentration. Output: absorbance change measured via turbidimetry on Roche/Hitachi 917 analyzer; concentration determined by interpolation from a calibration curve. Used in clinical laboratories by trained personnel. Output aids clinicians in diagnosing iron overload and iron deficiency anemia, potentially benefiting patients through timely identification of iron-related disorders.

Clinical Evidence

No clinical prospective or retrospective studies provided. Performance supported by bench testing: precision (CV < 7%), linearity (R ≥ 0.99, range 2-1000 ng/mL), and analytical specificity (no interference from hemoglobin, bilirubin, lipids, or rheumatoid factor). Method comparison with predicate (n=64) showed correlation coefficient R=0.9969, slope 0.89. Matrix comparison (n=20) confirmed equivalence between serum, EDTA, and sodium heparin plasma.

Technological Characteristics

Latex-enhanced immunoturbidimetric assay. Reagents: reaction buffer and latex particles coated with rabbit anti-human ferritin antibodies. Instrument: Roche/Hitachi 917 analyzer. Calibration: 5-point curve using liquid calibrators. Traceability: 1st WHO International reference Preparation Human Ferritin (BIBSC 80/602).

Indications for Use

Indicated for quantitative determination of ferritin in human serum and plasma to aid in the diagnosis of iron overload and iron deficiency anemia. No specific age or gender contraindications provided.

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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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Kamiva Biochemical Company c/o Mr. Brian Schliesman Director 12779 Gateway Dr. Seattle, WA 98168

DEC 2 3 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Re: k050944

Trade/Device Name: K-Assay® Ferritin (2) and K-Assay® Ferritin Calibrator Set Regulation Number: 21 CFR 866.5340 Regulation Name: Ferritin immunological test system Regulatory Class: Class II Product Code: DBF, JIT Dated: April 6, 2005 Received: April 21, 2005

Dear Mr. Schliesman:

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 application (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 such 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 Parl 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to legally marketed predicate device results in a classification 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 questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 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/cdrh/industry/support/index.html

Sincerely yours,

Robert Beckerh

Robert L. Becker, Jr., MD, PH.D 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 STATEMENT

510(k) Number (if known): KO50944 4

K-ASSAY® Ferritin (2) and K-ASSAY® Ferritin Calibrator Set Device Name:

Indications For Use:

The K-ASSAY® Ferritin (2) assay is an in vitro diagnostic reagent for the quantitative determination of ferritin (an iron-storing protein) in human serum and plasma by immunoturbidimetric assay on the Roche / Hitachi 917 analyzer. Measurements of ferritin aid in the diagnosis of diseases affecting iron overload and iron deficiency anemia. For in vitro diagnostic use.

The K-ASSAY® Ferritin Calibrator Set is an in vitro diagnostic reagent for calibration of the K-ASSAY® Ferritin (2) Assay.

For in vitro diagnostic use.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

maria r for Concurrence of CD Miston State Evaluation (ODE)

> Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K050944

Prescription Use × (Per 21 CFR 801.109) Over-The-Counter Use

Optional Format 1-2-96)

4/06/2005

Ferritin (2) 510(k) KAMIYA BIOMEDICAL COMPANY OR