TOTAL IRON, MODELS FE 109-01, FE 109-02

K991244 · A.P. Total Care, Inc. · JMO · May 25, 1999 · Clinical Chemistry

Device Facts

• Record ID: K991244
• Device Name: TOTAL IRON, MODELS FE 109-01, FE 109-02
• Applicant: A.P. Total Care, Inc.
• Product Code: JMO · Clinical Chemistry
• Decision Date: May 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1415
• Device Class: Class 1

Intended Use

The total iron reagents: Buffer, pH 4.5 (R1), product No. FE109-01 and Color reagent, product No. FE109-02 are for use in the automated, quantitative determination of Total Iron in serum, or plasma.

Device Story

Total Iron reagents (Buffer pH 4.5 and Color reagent) are in vitro diagnostic chemical reagents used for the quantitative measurement of iron levels in human serum or plasma samples. The device is intended for use on automated clinical chemistry analyzers in a laboratory setting. The reagents react with iron in the patient sample to produce a measurable color change, which is detected by the analyzer's spectrophotometric system. The resulting quantitative output allows clinicians to assess iron status, aiding in the diagnosis and management of conditions such as iron deficiency anemia or iron overload. The device is operated by trained laboratory personnel.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic chemical reagents (Buffer pH 4.5 and Color reagent). Principle of operation is colorimetric spectrophotometry for iron quantification. Designed for use on automated clinical chemistry analyzers.

Indications for Use

Indicated for the automated, quantitative determination of Total Iron in human serum or plasma for clinical diagnostic purposes. Prescription use only.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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MAY 25 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K991244 Trade Name: Total Iron Requlatory Class: II Product Code: JMO April 07, 1999 Dated: April 12, 1999 Received:

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 Requlation (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 In addition, FDA may publish further regulatory action. 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 Putman

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): | K991244 |
|---------------------------|------------|
| Device Name: | TOTAL IRON |

Indications For Use:

The total iron reagents: Buffer, pH 4.5 (R1), product No. FE109-01 and Color reagent, The lotal non reagents. Dance, pro no (201) productio use in the automated, quantitative determination of Total Iron in serum, or plasma.

Jean Coogr
(Division Sign-Off)
Division of Clinical Laboratory
510(k) Number K991244

(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_

(Optional Format 1-2-96)