MAGNETIC TIBC KIT

K990216 · Reference Diagnostics, Inc. · JMO · Feb 16, 1999 · Clinical Chemistry

Device Facts

• Record ID: K990216
• Device Name: MAGNETIC TIBC KIT
• Applicant: Reference Diagnostics, Inc.
• Product Code: JMO · Clinical Chemistry
• Decision Date: Feb 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1415
• Device Class: Class 1

Intended Use

For in vitro diagnostic use only. The Magnetic TIBC Kit quantitatively measures total iron-biding capacity in serum.

Device Story

The Magnetic TIBC Kit is an in vitro diagnostic test used to measure total iron-binding capacity in serum samples. It is intended for use in clinical laboratory settings by trained personnel. The device utilizes a magnetic separation method to isolate iron-binding proteins. The output is a quantitative measurement of TIBC, which assists clinicians in diagnosing and monitoring anemia, specifically differentiating between chronic illness-related anemia and iron deficiency anemia. The test results are used by physicians to guide clinical decision-making regarding patient iron status and treatment plans.

Clinical Evidence

Bench testing only. A correlation study was performed comparing the Magnetic TIBC Kit to the J & S microcolumn method using 103 serum samples. The study demonstrated a correlation of 0.99 with a regression equation of y = 1.02x - 5.7.

Technological Characteristics

In vitro diagnostic kit utilizing magnetic separation technology for the quantitative measurement of TIBC in serum. The device is a chemical reagent-based assay system.

Indications for Use

Indicated for the quantitative measurement of total iron-binding capacity (TIBC) in serum to evaluate the cause and progression of anemia, specifically to differentiate between anemia resulting from chronic illness and iron deficiency anemia.

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.

Predicate Devices

• J & S Microcolumn and Iron Saturating reagent kit for TIBC

Submission Summary (Full Text)

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2/16/99

K990216

## SUMMARY OF SAFETY AND EFFECTIVENESS

A comprehensive evaluation was performed between the Magnetic TIBC Kit and the predicate device to determine if they are substantially equivalent

A correlation between the Magnetic TIBC method and the J & S microcolumn method was obtained using a total of 103 samples. The following relationship was obtained:

・・・・

# y = 1.02x - 5.7 with a correlation of 0.99

Based upon this information, Reference Diagnostics, Inc. believes that the Magnetic TIBC Kit is substantially equivalent to the J & S Microcolumn and Iron Saturating reagent kit for TIBC.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 16 1999

Joseph Lawlor, Ph.D. President Reference Diagnostics, Inc. 23 Crosby Drive Bedford, MA 01730-1401

Re: K990216 Trade Name: Magnetic TIBC Kit Regulatory Class: I Product Code: 75 JMO Dated: January 21, 1999 Received: January 22, 1999

Dear Dr. Lawlor:

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 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). 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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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### Statement of Intended Use

Page 1 of 1

510(k) Number (if known):

Device Name:

Magnetic TIBC Kit

### Indications For Use:

For in vitro diagnostic use only. The Magnetic TIBC Kit quantitatively measures total iron-biding capacity in serum.

### Summary and Explanation of the Test:

Total iron-binding capacity (TIBC) is used to evaluate the cause and progression of anemia. This measurement helps to differentiate between anemia resulting from chronic illness and iron anto (Division Sign-Off) deficiency anemia.

Division of Clinical Laboratory Devices
510(k) Number K990216

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The Counter Use