SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30

K973933 · Diagnostic Chemicals , Ltd. · JIY · Nov 4, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973933
• Device Name: SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: JIY · Clinical Chemistry
• Decision Date: Nov 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1410
• Device Class: Class 1

Intended Use

For the quantitative determination of iron in serum. For IN VITRO diagnostic use.

Device Story

Serum Iron-SL Assay is an in vitro diagnostic reagent used for the quantitative measurement of iron levels in human serum. The assay is intended for use by clinical laboratory professionals. It functions via chemical reaction to determine iron concentration, providing data that assists clinicians in assessing iron status and diagnosing related disorders. The device is used in clinical laboratory settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic chemical assay for serum iron quantification. Reagent-based colorimetric or similar chemical detection method. Intended for use on automated clinical chemistry analyzers.

Indications for Use

Indicated for the quantitative determination of iron in human serum for in vitro diagnostic use.

Regulatory Classification

Identification

An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Karen Callbeck, R.T., B.Sc. Regulatory Affairs Coordinator Diaqnostic Division Diagnostic Chemicals Limited West Royalty Industrial Park Charlottetown, PE, CANADA

NOV - 4 1997

K973933 Re: Trade Name: Serum Iron-SL Assay, Catalogue Numbers 157-10,157-30 Regulatory Class: I I Tier: Product Code: JIY Dated: September 30, 1997 Received: October 15, 1997

Dear Ms. Callbeck:

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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 requlatory 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 miqht 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 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 Sutman

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): | K973933 |
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|---------------------------|---------|

Device Name: Serum Iron-SL Assay

## Indications For Use:

For the quantitative determination of iron in serum. For IN VITRO diagnostic use.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of ClinicalDevices K973933
510(k) Number

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

(Optional Format 1-2-96)

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