RANDOX IRON

K974604 · Randox Laboratories, Ltd. · JMO · Jan 6, 1998 · Clinical Chemistry

Device Facts

• Record ID: K974604
• Device Name: RANDOX IRON
• Applicant: Randox Laboratories, Ltd.
• Product Code: JMO · Clinical Chemistry
• Decision Date: Jan 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1415
• Device Class: Class 1

Intended Use

The Randox Laboratories Limited Iron Test Kit is an in vitro diagnostic reagent for the quantitative determination of iron in human serum. The method is based on the reaction of ferrous iron with the chromogen ferrozine to produce a coloured chromophore which can be detected at 570nm. Serum iron may be used to distinguish between different types of anaemias and to identify conditions involving iron deficiency. This test kit must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Device Story

The Randox Iron Test Kit is an in vitro diagnostic reagent system used in clinical laboratory settings. It measures iron levels in human serum samples. The principle of operation involves a chemical reaction where ferrous iron reacts with the chromogen ferrozine to form a colored chromophore. This chromophore is detected via spectrophotometry at a wavelength of 570nm. The resulting quantitative measurement of serum iron assists healthcare providers in distinguishing between different types of anaemias and identifying iron deficiency conditions. The device is intended for professional use by qualified laboratory personnel under controlled laboratory conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent kit; utilizes ferrozine chromogen-based colorimetric assay; detection via spectrophotometry at 570nm; intended for use with standard laboratory instrumentation.

Indications for Use

Indicated for the quantitative determination of iron in human serum to assist in the diagnosis of anaemias and iron deficiency conditions. For use by qualified laboratory personnel.

Regulatory Classification

Identification

An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

**JAN - 6 1998**

Dr. P. Armstrong Randox Laboratories, Ltd. Ardmore, Diamond Road Crumlin, Co. BT29 4QY Antrim, United Kingdom

K974604 Re : Randox Iron II Requlatory Class: Product Code: JMO Dated: December 8, 1997 December 10, 1997 Received:

Dear Dr. Armstrong:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marrice 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 You may, therefore, Food, Drug, and Cosmetic Act (Act). market the device, subject to the general controls provisions The general controls provisions of the Act 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 In addition, FDA may publish further announcements action. 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 requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (Chiration. 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 described in your cial equivalence of your device to a legally marketed predicate device results in a classification for your markets production 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 che regulation entitled, "Misbranding by reference to 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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

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

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Enclosure

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| | | | | CALLER AND CONSULTER COLLEGE OF CHARRET OF |
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| 0(k) Number (if known) | NOT KNOWN |
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| vice Name | IRON |

dications For Use :

ne Randox Laboratories Limited Iron Test Kit is an *in vitro* diagnostic reagent for the
Jantitative determination of iron in human serum. The method is based on the reaction of
rrous iron with the chromogen ferrozine to produce a coloured chromophore which can
e detected at 570nm. Serum iron may be used to distinguish between different types of
aemias and to identify conditions involving iron deficiency.

his test kit must be used by suitably qualified laboratory personnel under appropriate
boratory conditions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| 'Yescription Use<br>Per 21 CFR 801.109) | OR | Over-The-Counter Use<br>(Optional format 1-2-96) |
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(Division Sign-Off)

Division of Clinical

| 510(k) Number | 12974604 |
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