ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA

K971834 · Monobind · JNL · Jul 3, 1997 · Immunology

Device Facts

• Record ID: K971834
• Device Name: ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA
• Applicant: Monobind
• Product Code: JNL · 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 thyroid peroxidase (TPO) autoantibodies in human serum or plasma by a microplate enzymeimmunoassay. Measurements of TPO autoantibodies may aid in the diagnosis of certain thyroid diseases such as Hashimoto, Graves, and nontoxic goiter.

Device Story

The Anti-Thyroid peroxidase (TPO) Microplate ELISA is an in vitro diagnostic kit used to measure TPO autoantibodies in human serum or plasma. The device utilizes ELISA technology based on a streptavidin-biotin reaction. Biotinylated thyroid peroxidase antigen and patient serum are mixed, forming an immune complex that binds to streptavidin-coated wells. After incubation and washing, an enzyme-linked anti-h-IgG conjugate is added. The resulting enzyme activity is directly proportional to the antibody concentration in the specimen. A reference curve is generated using serum references of known activity to quantify the unknown sample. The test is performed in a laboratory setting by trained personnel. Results assist clinicians in diagnosing thyroid conditions such as Hashimoto's thyroiditis, Graves' disease, and thyroid nodules or carcinoma.

Clinical Evidence

Clinical comparison performed using 82 biological specimens from normal and disease-state populations, including Hashimoto's thyroiditis, Graves' disease, thyroid nodules, and thyroid carcinoma. The study compared the subject device against a reference method, yielding a correlation coefficient of 0.989 and a linear regression equation of y = 1.02(x) - 5.1. Linearity studies demonstrated an average 101.2% recovery when specimens were diluted and compared to the dose-response curve.

Technological Characteristics

ELISA-based microplate immunoassay. Utilizes streptavidin-coated wells and biotinylated thyroid peroxidase antigen. Detection via enzyme-linked anti-h-IgG (HRP conjugate). Standardized against WHO 66/387 international reference material. Manual or automated plate processing.

Indications for Use

Indicated for the quantitative determination of thyroid peroxidase (TPO) 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-thyroid peroxidase 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, interconnected "M" and "B" in a bold, black color. Below the logo, the text "MONOBIND, INC." is printed in a simple, sans-serif font. Underneath the company name, the date "May. 16. 97" is printed.

JUL 3 1997

510(k) Summarv

Dear Sir:

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

The proprietary name is Anti-Thyroid peroxidase (TPO) Microplate ELISA and the usual name is Anti-TPO ELISA. This device classification name is - thyroid autoantibody Immunological test system - product code JNL (per 21 CRF section 866.5870).

This device is substantlally equivalent to the Biomerica anti-thyroid peroxidase 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 thyroid peroxidase antigen, and a serum containing the autoantibody (anti-TPO), reaction results between the biotinylated theroid peroxidase 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 thyroid peroxidase antigen. After incubation is complete, decantation or aspiration separates the unbound components. The enzyme linked specific antibody (anti-h-lgG) is then added to the microwells. The anti-h-igG 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 thyroid peroxidase (TPO) 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 thyroid peroxidase antigen, and diluted human serum prepared callbrators (standardized against the same international reference material WHO 66/387). The main difference lies in that the antigen is pre-coated on the well (Blomerica method) versus being deposited during incubation (Monobind procedure). Both methods use anti-higG-HRP) to expose the antibody activity on the solid phase. The 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 are 127.0 IU/ml and 122.9 IU/ml respectively. The equation to a straight-line [ y= 1.02(x) - 5.1 ] and correlation coefficient (0.989) indicates good method agreement.

In addition, Ilnearly studies showed an average 101.2% 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wing shapes, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the eagle symbol.

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: K971834 Trade Name: Anti-thyroid (TPO) Microplate ELISA Regulatory Class: II Product Code: JNL 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 premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Flectronic Product 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 Autman

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): K971834

Device Name: Anti-thyroid peroxidase(TPO) Microplate ELISA

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

Petre Mafeni

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

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

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

Prescription Use
(Per 21 CFR 801.109) OR

(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Folmat 1-2-96)