TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02

K991666 · A.P. Total Care, Inc. · JMO · Jun 30, 1999 · Clinical Chemistry

Device Facts

• Record ID: K991666
• Device Name: TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02
• Applicant: A.P. Total Care, Inc.
• Product Code: JMO · Clinical Chemistry
• Decision Date: Jun 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1415
• Device Class: Class 1

Intended Use

The Total Iron Binding Capacity (TIBC) reagents, product No. FE109-01, FE109-02 and The Total Iron Binding Capacity (TIDO) reagones processor seni-automated, quantitative determination of TIBC in serum, or plasma.

Device Story

Device consists of chemical reagents for the quantitative determination of Total Iron Binding Capacity (TIBC) in serum or plasma samples. Used in clinical laboratory settings; processed via semi-automated analyzers. Reagents facilitate the measurement of iron-binding capacity, aiding clinicians in assessing iron metabolism and diagnosing conditions related to iron deficiency or overload. Output is a quantitative concentration value used to inform clinical decision-making regarding patient iron status.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic chemical reagents for TIBC determination. Designed for use with semi-automated laboratory processors. Principle of operation is based on standard biochemical assay methods for iron binding capacity measurement.

Indications for Use

Indicated for the quantitative determination of Total Iron Binding Capacity (TIBC) in human serum or plasma for clinical diagnostic use.

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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JUN 30 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

A.P. Total Care c/o Mr. Luis P. Leon Catachem, Inc. 70 Hawley Avenue P.O. Box 6216 Bridgeport, Connecticut

Re: K991666

> Trade Name: Total Iron Binding Capacity (TIBC) Regulatory Class: II Product Code: JMO Dated: May 8, 1999 Received: May 14, 1999

Dear Mr. Leon:

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 QS 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 [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/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): ____________________________________________________________________________________________________________________________________________________

Total Iron Binding Capacity Device Name:__________________________________________________________________________________________________________________________________________________________________ (TIBC)

## Indications For Use:

The Total Iron Binding Capacity (TIBC) reagents, product No. FE109-01, FE109-02 and The Total Iron Binding Capacity (TIDO) reagones processor seni-automated, quantitative determination of TIBC in serum, or plasma.

(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__________________________________________________________________________________________________________________________________________________________

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