T-UPTAKE MICROPLATE EIA

K980088 · Monobind · KHQ · Feb 4, 1998 · Clinical Chemistry

Device Facts

• Record ID: K980088
• Device Name: T-UPTAKE MICROPLATE EIA
• Applicant: Monobind
• Product Code: KHQ · Clinical Chemistry
• Decision Date: Feb 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1715
• Device Class: Class 2

Intended Use

The Measurement of the Total Amount of Binding Sites Available for the Thyroid Hormones in Human Serum or Plasma by a Microplate Enzyme Immunoassay. Measurements obtained from this device are used in the diagnosis and treatment of thyroid diseases.

Device Story

T-Uptake Microplate EIA measures unsaturated thyroid hormone binding capacity in human serum or plasma. Device utilizes microplate enzyme immunoassay (EIA) technology; wells coated with anti-thyroxine antibody. Input samples (serum/plasma) incubated with enzyme-T4 conjugate and thyroxine. Enzyme-T4 conjugate competes for binding sites; amount of enzyme bound to well inversely proportional to specimen's binding capacity. After incubation, enzyme activity quantitated via reaction with substrate. Absorbance measured and compared to dose-response curve generated from serum references of known capacity. Used in clinical laboratories; operated by laboratory technicians. Results assist clinicians in diagnosing and managing thyroid disorders.

Clinical Evidence

Clinical comparison performed using 120 specimens from hypothyroid, pregnant, euthyroid, and hyperthyroid populations. Method comparison between the new microplate EIA and the predicate radioassay showed a correlation coefficient of 0.972 and a linear regression equation of y = 1.56 + 0.966x. Mean values were 20.0 for the reference method and 29.3 for the new method.

Technological Characteristics

Microplate enzyme immunoassay (EIA). Components: plastic microplate wells coated with anti-thyroxine antibody, enzyme-T4 conjugate, and thyroxine. Detection principle: competitive binding enzyme immunoassay with colorimetric substrate reaction. Quantitation via absorbance measurement compared to reference curve. Standalone laboratory test.

Indications for Use

Indicated for the measurement of thyroid hormone binding sites in human serum or plasma to assist in the diagnosis and treatment of thyroid diseases in patients, including those with hypothyroid, euthyroid, and hyperthyroid conditions.

Regulatory Classification

Identification

A triiodothyronine uptake test system is a device intended to measure the total amount of binding sites available for binding thyroid hormone on the thyroxine-binding proteins, thyroid-binding globulin, thyroxine-binding prealbumin, and albumin of serum and plasma. The device provides an indirect measurement of thyrkoxine levels in serum and plasma. Measurements of triiodothyronine uptake are used in the diagnosis and treatment of thyroid disorders.

Predicate Devices

• Monobind T3 Uptake radioassay (RA)

Submission Summary (Full Text)

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KEJ

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K980088

Jan. 7, 98

510(k) Summary

Dear Sir:

Monobind inc., registedion number 2020726, piane to introduce into commercial thyrold hormone binding sites in human serum or plasma.

The proprietery name is T-Uptake (TV). Morquiste EIA and the usual neme le T-Uptake
EIA. This device classification name is - Tifledothyronine (T3) uptake test staten, product code KHQ fper 21 CRF section 862.1716).

This device is substantially equivalent to the Monobind T3 Uptake radioessay (RA), which predicates the new device.

The contact includual for this submission is Dr. Frederick R. Jerome.

The Monobind micropiate EIA utilizes limited amount of anti-inyroxine antibochy ritorial on the surface of plastic wells of a microllers. Speciments, collexiors
or controle are there seded by the enzyme-Te conjugate and thyrozine. The line in the added t ondageness antalig processor of the least be alight of the excyme only gets to epocimen increases. After the completion of the inculbetion portod, the eacyme-T4
onlyne on the well le quantitated by reaction with sultable substrator. The activity of the The employment of several serum references of known unsaturated thyrold hormone binding capacity permits construction of a graph of absorbance and concentration. From comparison to the dose response curve, an unknown specimen's absorbance can be correlated with thyrold hormone binding capacity

The intended use of the device: The Measurement of the Total Amount of Binding Sites Avaliable for the Thyrold Hormones in Human Serum or Plasma by a Micropiate Enzyme Immunossay.

The technological characteristics of the new device compared to the predicate device are seeentially identical. This includes identically propered callbrators, and the saturation of binding proteins with exogencusly added thyrold hormone. Main differences reside in the use of an enzyme tracer compared to a radiciscone. T4 versus T3 as the salurating thyroid hormons and antibody to plck up the unreacted thyrold hormones versus denatured albumin in the radioassay.

Substantial equivalency was based on clinical comparison filmear regression), using 120 specimens from hypothyroid, pregnant, euthyroid and hyperthyrold populations. The mean values for reference method (radicaseey) and this method (microplate EIA) are 20.0 and 29.3 respectively. The equation to a straight line (y= 1.56 + 0.966) and correlation cosficient (0.972) indicates good method sqreement.

> 726 West 16" Street , Costa Moss , CA (USA) 92627 Phone: [phone] FAX: [phone]

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 4 1998

Dr. Frederick R. Jerome · President Monobind, Inc. 729 West 16th Street Costa Mesa, California 92627

K980088 Re : T-Uptake Microplate EIA Regulatory Class: II Product Code: KHQ Dated: January 8,1998 Received: January 9, 1998

Dear Dr. Jerome:

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 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 The general controls provisions of the Act 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 In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register.

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/dsmamain.html".

Sincerely yours,
Steven Gutman

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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## Indications for Use Statement

| 510(k) Number (if known): | |
|---------------------------|--|
|---------------------------|--|

Device Name: T-Uptake Microplate EIA

The Measurement of the Total Amount of Binding Sites Available for the Thyroid Hormones in Human Serum or Plasma by a Microplate Enzyme Immunoassay. Measurements obtained from this device are used in the diagnosis and treatment of thyroid diseases.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Divi | |
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| Division | |
| 510(k) Number | K950088 |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use<br>(Optional Folmat 1-2-96) |
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