ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA

K971835 · Monobind · DDC · Jul 3, 1997 · Immunology

Device Facts

• Record ID: K971835
• Device Name: ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA
• Applicant: Monobind
• Product Code: DDC · Immunology
• Decision Date: Jul 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5870
• Device Class: Class 2

Intended Use

The quantitative determination of thyroglobulin (Tg) autoantibodies in human serum or plasma by a microplate enzymeimmunoassay. Measurements of Tg autoantibodies may aid in the diagnosis of certain thyroid diseases such as Hashimoto, Graves, and nontoxic goiter.

Device Story

Anti-Thyroglobulin (Tg) Microplate ELISA is an in vitro diagnostic test for human serum or plasma. The device uses ELISA technology with streptavidin-coated microwells. Biotinylated thyroglobulin antigen reacts with patient autoantibodies to form an immune complex, which is captured on the streptavidin-coated well. An enzyme-linked anti-human IgG conjugate binds to the immobilized complex. After washing, enzyme activity is measured, which is directly proportional to the antibody concentration in the specimen. A reference curve is generated using serum calibrators to quantify unknown samples. The test is performed in a laboratory setting. Results assist clinicians in diagnosing thyroid conditions such as Hashimoto's thyroiditis, Graves' disease, and thyroid nodules/carcinoma.

Clinical Evidence

Clinical comparison study using 82 biological specimens from normal and disease state populations (Hashimoto's thyroiditis, Graves' disease, thyroid nodules, thyroid carcinoma). Linear regression analysis yielded a correlation coefficient of 0.995 and a regression equation of y = 9.79 + 0.969(x). Mean values were 419.2 IU/ml (reference) and 415.6 IU/ml (subject). Linearity studies showed 98.7% average recovery.

Technological Characteristics

Microplate ELISA; streptavidin-biotin separation principle; enzyme-linked immunosorbent assay; anti-hIgG-HRP conjugate; purified thyroglobulin antigen; standardized against 1st IRP 65/93 reference material.

Indications for Use

Indicated for the quantitative determination of thyroglobulin autoantibodies in human serum or plasma to aid in the diagnosis of thyroid diseases including Hashimoto's thyroiditis, Graves' disease, and nontoxic goiter.

Regulatory Classification

Identification

A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.

Predicate Devices

• Biomerica anti-thyroglobulin ELISA test

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for MONOBIND, INC. The logo consists of a stylized letter "B" formed by two interconnected shapes. Below the logo, the text "MONOBIND, INC." is printed in a bold, sans-serif font. Underneath the company name, the date "May. 14, 97" is printed in a bold, italicized font.

K 921835

JUL - 3 1997

510(k) Summarv

Dear Sir:

Monobind Inc., registration number 2020726, plans to introduce into commercial distribution an ELISA kit for the determination of thyroglobulin autoantibodies in human serum or plasma.

The proprietary name is Anti-Thyroglobulin (Tg) Microplate ELISA and the usual name is Anti-Ta ELISA. This device classification name is - thyroid autoantibody immunological test system - product code DDC (per 21 CRF section 866.5870).

This device is substantially equivalent to the Biomerica anti-thyroglobulin ELISA test, which predicates the new device.

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

The Monobind method is based on ELISA technology utilizing the streptavidin-blotin reaction to effect separation. Upon mixing blotinylated thyroglobulin antigen, and a serum containing the autoantibody (anti-Tg), reaction results between the biotinylated thyroglobulin antigen and the antibodies to form an immune complex. Simultaneously, the complex is deposited to the well through the high affinity reaction of streptavidin, coated on the well, and biotinylated thyroglobulin antigen. After incubation is complete, decantation or aspiration separates the unbound components. The enzyme linked species specific antibody (anti-h-igG) is then added to the microwells. The anti-h-lgG enzyme conjugate that binds to the immobilized immune complex in a second incubation are separated from unreacted material by a wash step. The enzyme activity in this fraction Is directly proportional to the antibody concentration in the specimen. By utilizing several different serum references of known antibody activity, a reference curve can be generated from which the antibody activity of an unknown can be ascertained.

The intended use of the device: The quantitative determination of thyroglobulin (Tg) autoantibodies in human serum or plasma by a microplate enzymeimmunoassay.

The technological characteristics of the new device compared to the predicate device are very similar. This includes ELISA technology with highly purified thyroglobulin antigen. and diluted human serum prepared calibrators (standardized against the same international reference material 1st IRP 65/93). A difference lles in the use of anti-hlgG -HRP (Monobind method) versus HRP-Protein A (Biomerica method) to expose the antibody activity on the solid phase. However, both reagents' function is to detect anti-h-IgG on the solid phase. The enzyme and substrate systems are the same.

Substantial equivalency was based on clinical comparison (linear regression), using 82 biological specimens from normal and disease states populations. The disease states Included; Hashimoto's thyroiditis, Graves Disease, thyroid nodules as well as thyroid carcinoma. The mean values for reference method and this method are 419.2 IU/ml and 415.6 IU/ml respectively. The equation to a straight-line [ v= 9.79+0.969 (x) ] and correlation coefficient (0.995) Indicates good method agreement.

In addition, linearity studies showed an average 98.7% recovery 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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Image /page/1/Picture/0 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a human figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dr. Frederick Jerome 729 West 16th Street, C-4 Costa Mesa, CA 92627

JUL - 3 1997

Re: K971835 Trade Name: Anti-thyroglobulin (Tg) Microplate ELISA Regulatory Class: II Product Code: DDC Dated: May 14, 1997 Received: May 19, 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 Regulations, Title 21, Parts 800 to 895. A 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 the Federal Register.

Please note: this response to your promarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Preduct Radiation Control provisions, or other Federal Laws or Regulations.

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].

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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" (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 at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Toutman

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): K971835

Device Name: Anti-thyroglobulin(Tg) Microplate ELISA

The quantitative determination of thyroglobulin autoantibodies in human serum or plasma by a microplate enzymeimmunoassay. Measurements of Tg autoantibodies may aid in the diagnosis of certain thyroid diseases such as Hashimoto, Graves, and nontoxic goiter.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Deborah Moore for
Dr. Peter Maxim

(Division Sign-00
Division of Clinical Laboratory Devices
510(k) Number K971835

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Folmat 1-2-96)