QUANTEX FERRITIN

K040879 · Instrumentation Laboratory CO · DBF · May 10, 2004 · Immunology

Device Facts

• Record ID: K040879
• Device Name: QUANTEX FERRITIN
• Applicant: Instrumentation Laboratory CO
• Product Code: DBF · Immunology
• Decision Date: May 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5340
• Device Class: Class 2

Intended Use

Quantex Ferritin is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of ferritin in human serum or EDTA plasma on Clinical Chemistry Systems, and aids in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia. The quantex Ferritin controls I/I are intended for use in monitoring the quality control of results obtained with the quantex Ferritin reagents by turbidimetry. The quantex Ferritin standard multipoint is intended for use in establishing the calibration curve for the quantex Ferritin reagents by turbidimetry.

Device Story

Quantex Ferritin is a latex particle-enhanced immunoturbidimetric assay; measures ferritin levels in human serum or EDTA plasma samples. Operates on clinical chemistry systems; utilizes turbidimetry to quantify ferritin concentration. Provides quantitative results to clinicians; aids in diagnosing iron metabolism diseases like hemochromatosis and iron deficiency anemia. Includes dedicated controls and multipoint standards for calibration and quality monitoring. Used in clinical laboratory settings by trained personnel.

Clinical Evidence

No clinical studies performed. Evidence consists of analytical bench testing: precision (n=60, total CV 2.29-12.3%), linearity (R² 0.999-1.000), and method comparison (n=94, slope 0.9293). Interference testing confirmed minimal impact from lipemia, RF, bilirubin, and hemoglobin.

Technological Characteristics

Latex particle-enhanced immunoturbidimetric assay. Reagents: Ferritin R1 (buffer) and R2 (rabbit IgG anti-ferritin coated polystyrene latex). Calibrators: TRIS buffer with human ferritin. Controls: Lyophilized human ferritin. Connectivity: ILAB 900/1800 clinical chemistry systems. Traceability: 3rd WHO International Standard (NIBSC 94/572).

Indications for Use

Indicated for the quantitative determination of ferritin in human serum or EDTA plasma to aid in the diagnosis of iron metabolism disorders, including hemochromatosis and iron deficiency anemia. Intended for prescription use.

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.

Predicate Devices

• AxSYM Ferritin (K935847)

Submission Summary (Full Text)

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K040879

MAY 1 0 2004

# Section 3 quantex Ferritin 510(k) Summary (Summary of Safety and Effectiveness)

#### Submitted by:

Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: [phone] Fax: [phone]

#### Contact Person:

Carol Marble, Regulatory Affairs Director Phone: [phone] / Fax: [phone]

Summary Prepared:

April 2, 2004

Name of the device:

quantex Ferritin

#### Classification name(s):

| 866.5340 | Ferritin Immunological Test System |
|----------|---------------------------------------|
| DBF | Ferritin, Antigen, Antiserum, Control |

Class II

### Identification of predicate device(s):

K935847 AxSYM Ferritin

### Description of the device/intended use(s):

Quantex Ferritin is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of ferritin in human serum or EDTA plasma on Clinical Chemistry Systems, and aids in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.

The quantex Ferritin controls I/I are intended for use in monitoring the quality control of results obtained with the quantex Ferritin reagents by turbidimetry.

The quantex Ferritin standard multipoint is intended for use in establishing the calibration curve for the quantex Ferritin reagents by turbidimetry.

### Statement of Technological Characteristics of the Device Compared to Predicate Device:

Quantex Ferritin is substantially equivalent to the commercially available predicate device, AxSYM Ferritin, in performance and intended use.

#### Summary of Performance Data:

In a method comparison study evaluating 94 serum samples with Ferritin levels ranging from 3.2 to 1000 ng/ml on an ILab 900/1800, the slope was 0.92 and the correlation coefficient (r) was 0.994 for quantex Ferritin versus the predicate device.

Within precision assessed over multiple runs using quantex Ferritin controls VII on an Lab 900/1800 gave a CV of 4.1% (at a mean of 43.2 ng/mL) and 1.6% (at a mean of 402.8 ng/mL).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 0 2004

Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Co. 113 Hartwell Avenue Lexington, MA 02421

k040879 Re:

> Trade/Device Name: Quantex Ferritin Regulation Number: 21 CFR 866.5340 Regulation Name: Ferritin immunological test system Regulatory Class: Class II Product Code: DBF, JJX, JIT Dated: May 03, 2004 Received: May 04, 2004

Dear Ms. Marble:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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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/dsma/dsmamain.html.

Sincerely yours,

Joseph L. Ardolett

Joseph L. Hackett, Ph.D. Acting 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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# Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: quantex Ferritin

Indications for Use:

Quantex Ferritin is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of ferritin in human serum or EDTA plasma on Clinical Chemistry Systems, and aids in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.

The quantex Ferritin controls VII are intended for use in monitoring the quality control of results obtained with the quantex Ferritin reagents by turbidimetry.

The quantex Ferritin standard multipoint is intended for use in establishing the calloration curve for the quantex Ferritin reagents by turbidimetry.

Prescription Use
(Part 21 CFR 801 Subpart D)

OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Marie Chan

**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

KO40879 510(k) _______________________________________________________________________________________________________________________________________________________________________

Section 2

quantex Ferritin 510(k)

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