IL TEST IRON

K972363 · Instrumentation Laboratory CO · JIY · Aug 15, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972363
• Device Name: IL TEST IRON
• Applicant: Instrumentation Laboratory CO
• Product Code: JIY · Clinical Chemistry
• Decision Date: Aug 15, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1410
• Device Class: Class 1

Intended Use

IL Test™ Iron is intended for the quantitative in vitro diagnostic determination of iron in human serum and plasma using the ferene method on Instrumentation Laboratory's line of clinical chemistry systems. A total iron binding capacity (TIBC) determination can also be performed using IL Test™ Iron in conjunction with the IL Test™ TIBC Sample Preparation Kit.

Device Story

IL Test™ Iron is an in vitro diagnostic reagent kit for quantitative iron measurement in human serum and plasma. It utilizes the ferene method for colorimetric analysis on Instrumentation Laboratory clinical chemistry systems. The device is used in clinical laboratory settings by trained personnel. It provides iron concentration values, which clinicians use to diagnose and manage iron deficiency anemia, hemochromatosis, and chronic renal disease. When used with the IL Test™ TIBC Sample Preparation Kit, it also enables total iron binding capacity (TIBC) determination. The output assists healthcare providers in assessing iron status and guiding therapeutic decisions.

Clinical Evidence

Method comparison study of 105 serum samples. Correlation (r) for iron measurement was 0.9933 (Monarch) and 0.9986 (ILab). Correlation (r) for TIBC measurement was 0.9920 (Monarch) and 0.9988 (ILab).

Technological Characteristics

In vitro diagnostic reagent kit utilizing the ferene method for colorimetric iron determination. Designed for use on Instrumentation Laboratory clinical chemistry systems. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for quantitative in vitro diagnostic determination of iron in human serum and plasma for the diagnosis and treatment of iron deficiency anemia, hemochromatosis, and chronic renal disease.

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.

Predicate Devices

• IL Test™ Iron (K871973)
• Monarch Clinical Chemistry System (K932467)
• ILab Clinical Chemistry System (K932467)

Submission Summary (Full Text)

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K972363

AUG 1 5 1997

## SECTION 3 IL Test™ Iron - 510(k) SUMMARY (Summary of Safety and Effectiveness)

#### Submitted by:

Betty Lane Director, Regulatory Affairs Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 Phone: [phone] Fax: [phone]

#### Contact Person:

Betty Lane Phone: [phone]

#### Summary Prepared:

June 18, 1997

### Name of the device:

IL Test™ Iron

#### Classification name(s):

862.1410

Iron (non-heme) test systems

Class I

#### Identification of predicate device(s):

IL Test™ Iron K871973 for Monarch Clinical Chemistry System K932467 for ILab Clinical Chemistry System

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

IL Test™ Iron permits the quantitative in vitro diagnostic determination of iron in human serum and plasma using the ferene method on Instrumentation Laboratory's line of clinical chemistry instruments. Measurements of the levels of iron are used in the diagnosis and treatment of iron deficiency anemia, hemochromatosis and chronic renal disease. A total iron binding capacity (TIBC) determination can also be performed using IL Test™ Iron in conjunction with the IL Test™ TIBC Sample Preparation Kit.

## Statement of how the Technological Characteristics of the Device compare to the Predicate device:

IL Test™ Iron uses the same test principle as the predicate IL Test™ Iron and is substantially equivalent in performance, intended use, and safety and effectiveness.

#### Summary of Performance Data:

In a method comparison study evaluating 105 serum samples, the correlation (r) of the "new" IL Test™ Iron to the predicate IL Test™ Iron on the Monarch Clinical Chemistry System was 0.9933 and on the ILab Clinical Chemistry System was 0.9986. A comparison study of total iron binding capacity for the "new" versus the "predicate" IL Test™ Iron showed a correlation (r) of 0.9920 on the Monarch and 0.9988 on the ILab.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three curved lines representing the human services aspect. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 1 5 1997

Ms. Betty Lane Director Requlatory Affairs Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173

K972363 Re: IL Test Iron Requlatory Class: I Product Code: JIY Dated: June 24, 1997 Received: June 25, 1997

Dear Ms. Lane:

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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 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 deyice 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 Other qeneral 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 Litman

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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# Indications for Use Statement

510(k) Number (if known): _

Device Name: IL Tèst™ Iron I

# Indications for Use:

IL Test™ Iron is intended for the quantitative in vitro diagnostic determination of iron in human serum and plasma using the ferene method on Instrumentation Laboratory's line of clinical chemistry systems. A total iron binding capacity (TIBC) determination can also be performed using IL Test™ Iron in conjunction with the IL Test™ TIBC Sample Preparation Kit.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Diaries of William Earl Montgomery

ratory Devices

| Prescription Use<br>(Per 21 CFR 801.019) | ✓ |
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OR

Over-The-Counter Use _

Section 2

IL Test™ Iron 510(k)

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