OPTICOAT T4 EIA KIT

K982298 · Biotecx Laboratories, Inc. · KLI · Feb 3, 1999 · Clinical Chemistry

Device Facts

• Record ID: K982298
• Device Name: OPTICOAT T4 EIA KIT
• Applicant: Biotecx Laboratories, Inc.
• Product Code: KLI · Clinical Chemistry
• Decision Date: Feb 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1700
• Device Class: Class 2

Intended Use

A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

Device Story

OptiCoat T, EIA Kit is an in vitro diagnostic test system for quantitative measurement of total thyroxine (T4) in human serum. Device utilizes enzyme immunoassay (EIA) technology to detect thyroid hormone levels. Intended for use in clinical laboratory settings by trained laboratory personnel. Healthcare providers use quantitative results to assess thyroid function, aiding in diagnosis and management of thyroid disorders. System provides objective biochemical data to support clinical decision-making regarding patient thyroid status.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Enzyme immunoassay (EIA) test system for serum analysis. Quantitative measurement of total thyroxine (T4).

Indications for Use

Indicated for the measurement of total (free and protein bound) thyroxine (thyroid hormone) in serum to aid in the diagnosis and treatment of thyroid diseases in patients.

Regulatory Classification

Identification

A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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Public Health Service

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EEB 3 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mohan Mehra, Ph.D. President Biotecx Laboratories, Inc. 6023 South Loop East Houston, Texas 77033

Re: K982298 Trade Name: OptiCoat T, EIA Kit Regulatory Class: II Product Code: KLI Dated: January 11, 1999 Received: January 12, 1999

Dear Dr. Mehra:

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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Ref: 1960

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510(k) Number (if known): K982298

Device Name: T4 EIA Kit

Indications For Use:

A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

Dean Hooper

(Division Sign-Off)
Division of Clinical Laboratory Levices
510(k) Number K982298

(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 801.1009)

OR

Over-the-Counter Use

(Optional Format 1-2-96)