FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300

K020548 · Monobind · CEC · Apr 5, 2002 · Clinical Chemistry

Device Facts

• Record ID: K020548
• Device Name: FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300
• Applicant: Monobind
• Product Code: CEC · Clinical Chemistry
• Decision Date: Apr 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1695
• Device Class: Class 2

Intended Use

Free T4 test device is an in vitro diagnostic test system for the quantitative determination of circulating Free T4 (non-protein bound Thyroxine) in human serum. It is intended strictly for invitro diagnostic use as an aid to clinical diagnosis of thyroid diseases.

Device Story

Monobind Free T4 Microwell EIA is an in vitro diagnostic test system; utilizes enzyme immunoassay (EIA) technology to measure non-protein bound Thyroxine in human serum. Device used in clinical laboratory settings by trained personnel. Input is human serum sample; output is quantitative concentration of Free T4. Results assist clinicians in diagnosing thyroid-related conditions. Device provides objective data to support clinical assessment of thyroid function.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and performance characteristics typical of EIA diagnostic systems.

Technological Characteristics

Enzyme immunoassay (EIA) test system; microwell format; quantitative measurement of Free T4 in human serum; in vitro diagnostic use.

Indications for Use

Indicated for the quantitative determination of circulating Free T4 (non-protein bound Thyroxine) in human serum as an aid in the clinical diagnosis of thyroid diseases.

Regulatory Classification

Identification

A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three horizontal lines that curve downwards. The logo also includes the text "HEALTH & HUMAN SERVICES USA" arranged in a semi-circle around the top of the caduceus.

## Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR = 5 2002

Mr. Jay Singh Regulatory Affairs Monobind, Inc. 729 West 16th Street - Suite C-4 Costa Mesa, CA 92627

> k020548 Trade/Device Name: Monobind, Free T4 (Thyroxine) Microwell EIA Regulation Number: 21 CFR 862.1695 Regulation Name: Free thyroxine test system Regulatory Class: Class II Product Code: CEC Dated: February 15, 2002 Received: February 19, 2002

Dear Mr. Singh:

Re:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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): K020548.

Device Name: Monobind, Free T4 (Thyroxine) Microwell EIA.

Free T4 test device is an in vitro diagnostic test system for the quantitative determination of circulating Free T4 (non-protein bound Thyroxine) in human serum. It is intended strictly for invitro diagnostic use as an aid to clinical diagnosis of thyroid diseases.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: _

OR

Over-The-Counter (OTC) Use

1

3

(Per 21CFR 801.109)

(Optional Format 1-2-96).

(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number K111498