TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA

K971779 · Monobind · CDP · Jun 16, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971779
• Device Name: TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA
• Applicant: Monobind
• Product Code: CDP · Clinical Chemistry
• Decision Date: Jun 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1710
• Device Class: Class 2

Intended Use

The quantitative determination of total triiodothyronine concentration in human serum or plasma by a microplate enzymelmmunoassay.

Device Story

Total Triiodothyronine (T3) Microplate EIA is an enzyme immunoassay for measuring T3 levels in human serum or plasma. The device uses anti-T3 antibodies immobilized on plastic microtiter plate wells. During testing, patient samples, calibrators, or controls are added alongside an enzyme-T3 conjugate. A competition reaction occurs between native T3 in the sample and the enzyme-T3 conjugate for limited antibody binding sites. After incubation, unreacted material is decanted. The remaining enzyme activity is quantified by adding a substrate that produces a color change, measured via spectrophotometry. The test is performed in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing and managing thyroid disorders, including hyperthyroidism.

Clinical Evidence

Clinical comparison performed using 120 specimens from hypothyroid, euthyroid, and hyperthyroid populations. Comparison between reference coated tube RIA and subject microplate EIA showed mean values of 168 and 162, respectively. Linear regression yielded y=3.8+0.947 with a correlation coefficient of 0.987. Recovery data showed 102.1% average recovery of exogenous T3; linearity studies showed 95.7% average recovery.

Technological Characteristics

Microplate-based enzyme immunoassay. Components include anti-T3 antibody immobilized on plastic microtiter wells and enzyme-T3 conjugate. Detection via colorimetric substrate reaction. Non-radiolabeled format.

Indications for Use

Indicated for the quantitative determination of total triiodothyronine (T3) concentration in human serum or plasma to aid in the diagnosis and treatment of thyroid diseases, such as hyperthyroidism.

Regulatory Classification

Identification

A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.

Predicate Devices

• Monobind total trilodothyronine (T3) coated tube radioimmunoassay (RIA)

Submission Summary (Full Text)

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K97179

JUN 1 6 1997

Image /page/0/Picture/2 description: The image shows a logo for Monobind, Inc. The logo features a stylized, interconnected "MB" design in bold, black lines. Below the symbol, the words "MONOBIND, INC." are printed in a simple, sans-serif font, also in black.

Mav. 9. 97

510(k) Summary

Dear Sir:

Monobind Inc. , registration number 2020726, plans to introduce into commercial distribution an enzymelmmunoassay (EIA) kit for the determination of total trilodothyronine (T3) in human serum or plasma.

The proprietary name is Total Trilodothyronine (T3) Microplate EIA and the usual name Is T3 EIA. This device classification name is - enzyme immunoassay, non-radiolabeled, total trilodothyronine - product code CPD (per 21 CRF section 862.1710).

This device is substantially equivalent to the Monobind total trilodothyronine (T3) coated tube radioimmunoassay (RIA), which predicates the new device.

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

The Monobind microplate ElA utilizes anti-trilodothyronine antibody immobilized on the surface of plastic wells of a microtiterplate. Specimens, callbrators or controls are then added followed by the enzyme-T3 conjugate. A competition reaction results between the native trilodothyronine in the sample and the added enzyme-T3 conjugate for a limited number of antibody combining sites. After the completion of the Incubation period, the enzyme-T3 conjugate is separated from unreacted material by decantation. The activity of the enzyme on the well is quantitated by reaction with suitable substrate to produce color.

The Intended use of the device: The quantitative determination of total triiodothyronine concentration in human serum or plasma by a microplate enzymelmmunoassay.

The technological characteristics of the new device compared to the predicate device are essentially identical. This includes the use of the same anti-trilodothyronine antibody (coated on a plastic surface), identically prepared callbrators, sample size and the composition of the tracer buffer. The sole difference resides in the use of an enzyme tracer compared to a radioisotope.

Substantial equivalency was based on clinical comparison (linear regression), using 120 specimens from hypothyroid, euthyroid and hyperthyroid populations. The mean values for reference method (coated tube RIA) and this method (microplate EIA) are 168 and 162 respectively. The equation to a straight line (y= 3.8 + 0.947) and correlation coefficient (0.987) Indicates good method agreement.

In addition recovery data demonstrated an average recovery of 102.1% when exogenous added trilodothyronine was introduced into human serum specimens. Similarly, linearity studies showed an average 95.7% when a specimens were diffuted and compared to the dose response curve.

729 West 16" Street , Costa Mesa , CA (USA) 92627 Phone: [phone] FAX: [phone]

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

. IIIn I 6 1997

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

K971779 Re: Total Triiodothyronine (T3) Microplate EIA 体 Regulatory Class: II Product Code: CDP Dated: May 9, 1997 Received: May 14, 1997

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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (CMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Flease 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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Paqe 2

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 requlation (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): K971779

Device Name: Total Triiodothyronine (T3) EIA

The quantitative determination of total triiodothyronine concentration in human serum or plasma by a microplate i its qualified in the more of the may be are used in the diagnosis and treatment of thyroid. diseases such as hyperthyoidism.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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| Vision of Clinical Laboratory Devices | |
| 510(k) Number | K971779 |

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