THYROTROPIN(TSH) ELISA

K971780 · Monobind · JLW · Jun 24, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971780
• Device Name: THYROTROPIN(TSH) ELISA
• Applicant: Monobind
• Product Code: JLW · Clinical Chemistry
• Decision Date: Jun 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1690
• Device Class: Class 2

Intended Use

The quantitative determination of thyrotropin (TSH) concentration in human serum by a microplate enzymeimmunoassay. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

Device Story

Thyrotropin (TSH) ELISA is a microplate enzyme immunoassay (IEMA) for quantitative TSH measurement in human serum. Device utilizes two-site sandwich immunoassay technology; monoclonal biotinylated anti-TSH antibody and enzyme-labeled anti-TSH antibody form a soluble sandwich complex with native TSH antigen. Complex is deposited onto streptavidin-coated polystyrene wells via high-affinity streptavidin-biotin reaction. After incubation and separation (decantation/aspiration), enzyme activity is measured, which is directly proportional to TSH concentration. A dose-response curve is generated using known serum references to determine unknown concentrations. Used in clinical laboratory settings by trained personnel. Results assist healthcare providers in diagnosing thyroid or pituitary disorders.

Clinical Evidence

Clinical comparison study using 170 specimens from hypothyroid, euthyroid, and hyperthyroid populations. Compared subject microplate IEMA method to reference ICMA method. Mean values: 4.54 µIU/ml (subject) vs 4.21 µIU/ml (reference). Correlation coefficient 0.995; linear regression y=0.47+0.968. Recovery of exogenous TSH averaged 98.1%. Linearity studies averaged 99.2%.

Technological Characteristics

Two-site sandwich enzyme immunoassay (IEMA). Components: monoclonal biotinylated anti-TSH antibody, enzyme-labeled anti-TSH antibody, streptavidin-coated polystyrene wells. Detection principle: enzyme activity proportional to antigen concentration. Standardized against international reference material.

Indications for Use

Indicated for the quantitative determination of TSH in human serum to aid in the diagnosis of thyroid or pituitary disorders in patients.

Regulatory Classification

Identification

A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

Predicate Devices

• Ciba Corning ACS 180 chemiluminescence (ICMA) test

Submission Summary (Full Text)

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JUN 24 1997

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Mav. 10. 97

510(k) Summarv

Dear Sir:

Monobind Inc., registration number 2020726, plans to introduce into commercial distribution an enzymeimmunoassay (IEMA) kit for the determination of thyrotropin (TSH) In human serum.

The proprietary name is Thyrotropin (TSH) ELISA and the usual name is TSH IEMA. This device classification name is - thyroid-stimulating hormone test system - product code JLW (per 21 CRF section 862.1690).

This device is substantially equivalent to the Ciba Corning ACS 180 chemiluminescence (ICMA) test, which predicates the new device.

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

The Monobind ELISA method is based on two-site immunoassay (sandwich) technology utilizing the streptavidin-biotin reaction to effect separation. Upon mixing monoclonal biotinylated anti-TSH antibody, the enzyme-labeled anti-TSH antibody and a serum containing the native antigen (TSH), reaction results between the native antigen (TSH) and the antibodies, without competition or steric hindrance, to form a soluble sandwich complex. Simultaneously, the complex is deposited to the well through the high affinity reaction of streptavidin and biotinylated antibody. After incubation is complete, decantation or aspiration separates the bound fraction. The enzyme activity on the well is directly proportional to the native antigen (TSH) concentration. By utilizing several different serum references of known antigen values, a dose response curve can be generated from which the antigen concentration of an unknown can be ascertained.

The intended use of the device: The quantitative determination of therotropin (TSH) concentration in human serum by a microplate enzymelmmunoassay.

The technological characteristics of the new device compared to the predicate device are very similar. This includes the use of two-site immunoassay (sandwich) technology using monoclonal and polyclonal antibodies, and human serum prepared calibrators (standardized against the same international reference material). The main difference resides in the use of an enzyme tracer compared to chemiluminescence as well as magnetic particles versus streptavidin coated polystvrene wells.

Substantial equivalency was based on clinical comparison (linear regression), using 170 specimens from hypothyroid, euthyroid and hyperthyrold populations. The mean values for reference method (ICMA) and this method (microplate IEMA) are 4.21 ulU/mi and 4.54 µlU/mi respectively. The equation to a straight line (y= 0.47+ 0.968) and correlation coefficient (0.995) indicates good method agreement.

In addition recovery data demonstrated an average recovery of 98.1% when exogenous added thyrotropin was introduced into human serum specimens. Similarly, linearity studies showed an average 99.2% when specimens were diluted and compared to the dose response curve.

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

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

- -

JUN 24 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re : K971780 Thyrotropin (TSH) ELISA Regulatory Class: II Product Code: JLW Dated: May 13, 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 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 Requlations, Title 21, Parts 800 to 895. ಗ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. 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.

Image /page/1/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The image is in black and white.

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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): K971780

Device Name: Thyrotropin (TSH) Microplate EIA

The quantitative determination of thyrotropin (TSH) concentration in human serum by a microplate enzymeimmunoassay.Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K971780 |

| Prescription Use | <div style="display:inline-block; width:30px;">✓</div> | OR | Over-The-Counter Use | <div style="display:inline-block; width:30px;"></div> |
|----------------------|--------------------------------------------------------|----|--------------------------|-------------------------------------------------------|
| (Per 21 CFR 801.109) | | | (Optional Folmat 1-2-96) | |