AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501

K974505 · Alfa Biotech (Uk) , Ltd. · DBF · Feb 17, 1998 · Immunology

Device Facts

• Record ID: K974505
• Device Name: AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501
• Applicant: Alfa Biotech (Uk) , Ltd.
• Product Code: DBF · Immunology
• Decision Date: Feb 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5340
• Device Class: Class 2

Intended Use

The AuraFlex Ferritin assay is a fluorescent enzyme immunoassay for the quantitative determination of ferritin in human serum or plasma using the AuraFlex System. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemachromatosis (iron overload) and iron deficiency anemia.

Device Story

AuraFlex Ferritin is a fluorescent enzyme immunoassay used for quantitative ferritin measurement in human serum or plasma. The device operates on the AuraFlex System; it processes patient samples to determine ferritin levels. Results assist clinicians in diagnosing iron metabolism disorders, specifically iron deficiency anemia and hemochromatosis. The assay is intended for professional use in clinical laboratory settings.

Clinical Evidence

A comparison study was conducted using 94 human serum samples. The AuraFlex Ferritin assay was compared against another ferritin assay, yielding a correlation coefficient of 0.99.

Technological Characteristics

Fluorescent enzyme immunoassay reagents for use with the AuraFlex System. Quantitative measurement principle.

Indications for Use

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

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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K974505

## 10.0 510(K) SUMMARY

FEB 1 7 1998

A 510(k) Summary follows for the AuraFlex® Ferritin reagents described in this submission.

510(k) Summarv AuraFlex® Ferritin

:

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Submitter's Name: Alfa Biotech (UK) Ltd

Submitter's Address: Unit 4, Spring Lakes Estate, Deadbrook Lane, Aldershot, Hants, GU12 4UH

Submitter's Telephone: [phone]

Submitter's Contact: Mr M John Taylor

Date 510(k) Summary Prepared: 24 November 1997

Device Trade or Proprietary Name: AuraFlex® Ferritin

Device Common or Usual Name: Immunoassay for Ferritin

Device Classification Name: Ferritin Test System

Device Description: Fluorescent immunoassay reagents.

Device Intended Use: The AuraFlex® Ferritin assay is a fluorescent immunoassay for the quantitative determination of Ferritin in human serum or plasma using the AuraFlex System.

## Data Upon Which Substantial Equivalence was Determined:

A comparison study was conducted in which 94 human serum samples were assayed using the AuraFlex® Ferritin assay in singlicate. Results between the two assays showed a correlation of 0.99 (AuraFlex® Ferritin = 0.99 Other Ferritin assay + 1.9 ng/ml (ug/1).

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure embracing a globe, symbolizing the department's mission to protect and promote the health and well-being of all Americans.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

M. John Taylor Director of Quality and Regulatory Affairs Alfa Biotech (UK) Ltd. 4 Spring Lakes Estate Deadbrook Lane Aldershot, Hampshire GU12 4UH UNITED KINGDOM

FFB 17 1998

K974505 Re : Trade Name: AuraFlex® Ferritin Regulatory Class: II Product Code: DBF 82 November 24, 1997 Dated: December 01, 1997 Received:

Dear Mr. Taylor:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure ...... .............................................................................................................................................................

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510(k) Number (if known): K974505

Device Name: AURAFLEX Ferritin

Indications for Use:

AuraFlex Ferritin is a fluorescent enzyme immunoassay for the quantitative determination of ferritin in human serum or plasma using the AuraFlex System.

Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemachromatosis (iron overload) and iron deficiency anemia.

(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Madeni

(Division Sign-Off)
Division of Clinical Laboratory Devices K974505
510(k) Number

**Prescription Use**
(Per 21 CFR 801.109)

OR

## Over-The-Counter Use

(Optional Format 1-2-96)

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