IRON-PC-SL ASSAY MODEL # 151-10, 151-26

K020816 · Diagnostic Chemicals , Ltd. · JIY · May 14, 2002 · Clinical Chemistry

Device Facts

• Record ID: K020816
• Device Name: IRON-PC-SL ASSAY MODEL # 151-10, 151-26
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: JIY · Clinical Chemistry
• Decision Date: May 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1410
• Device Class: Class 1

Intended Use

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 and chronic renal disease. For the quantitative determination of iron in serum and heparinized plasma. For IN VITRO diagnostic use.

Device Story

Iron-PC-SL Assay is an in vitro diagnostic reagent system used to measure non-heme iron levels in serum and heparinized plasma samples. The device is intended for use in clinical laboratory settings by trained laboratory personnel. It provides quantitative iron measurements to assist clinicians in diagnosing and monitoring conditions such as iron deficiency anemia, hemochromatosis, and chronic renal disease. The assay utilizes chemical reagents to react with iron in the patient sample, producing a measurable signal that correlates with iron concentration. Results are reported to healthcare providers to inform clinical decision-making regarding patient iron status and therapeutic interventions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent system for quantitative iron measurement. Operates via chemical reaction for colorimetric or similar detection of non-heme iron in serum and heparinized plasma. Standalone reagent kit.

Indications for Use

Indicated for the quantitative determination of iron in serum and heparinized plasma for the diagnosis and treatment of diseases including iron deficiency anemia, hemochromatosis, and chronic renal disease. 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. Nancy Olscamp External Regulatory Affairs Coordinator Diagnostic Division Diagnostic Chemical Limited 16 McCarville Street Charlottetown PE Canada C1E 2A6

Re: k020816

> Trade/Device Name: Iron-PC-SL Assay Regulation Number: 21 CFR 862.1410 Regulation Name: Iron (non-heme) test system Regulatory Class: Class I Product Code: JIY Dated: March 12, 2002 Received: March 13, 2002

Dear Ms. Olscamp:

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.

MAY 1 4 2002

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

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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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Steven Butman

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) Notification

Iron-PC-SL Assay, Cat. No. 151-10, 151-26

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## Diagnostic Chemicals Limited

## INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K020816

Device Name: Iron-PC-SL Assay

## Indications for Use:

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 and chronic renal disease.

For the quantitative determination of iron in serum and heparinized plasma.

For IN VITRO diagnostic use.

zed plasma.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use .

OR

Over-The-Counter Use

(Per 21 CFR 801.109