SERAQUEST ANTI-THYROGLOBULIN

K023592 · Quest Intl., Inc. · DDC · Jan 6, 2003 · Immunology

Device Facts

• Record ID: K023592
• Device Name: SERAQUEST ANTI-THYROGLOBULIN
• Applicant: Quest Intl., Inc.
• Product Code: DDC · Immunology
• Decision Date: Jan 6, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5870
• Device Class: Class 2

Intended Use

The Anti-Thyroglobulin test is intended for the quantative detection of human IgG antibodies to thyroglobulin antigen, in human serum by enzyme immunoassay. The presence of antithyroglobulin antibodies can be used with other serological tests and clinical findings to aid in diagnosing individuals with Autoimmune Thyroditis and Grave's Disease. For In Vitro Diagnostic Use Only.

Device Story

SeraQuest Anti-Thyroglobulin is a solid-phase enzyme immunoassay (EIA) for detecting human IgG antibodies against thyroglobulin in human serum. The test uses microwells coated with purified human thyroglobulin. Patient serum is incubated in the wells; if anti-thyroglobulin antibodies are present, they bind to the immobilized antigen. After washing, an enzyme-labeled conjugate (goat anti-human IgG) is added, followed by a substrate. The enzyme converts the substrate into a yellow end-product, measured photometrically at 405 nm. Results are reported in IU/mL based on a standard curve calibrated to NIBSC standards. The test is performed in a laboratory setting by trained personnel. Clinicians use the quantitative results in conjunction with other serological tests and clinical findings to assist in diagnosing Autoimmune Thyroiditis and Graves' disease.

Clinical Evidence

Clinical study compared 144 serum specimens using the SeraQuest test and the Pharmacia Varelisa predicate. Excluding equivocal results, the SeraQuest test demonstrated a relative sensitivity of 97% (95% CI: 91.4-100%) and a relative specificity of 100% (95% CI: 99.9-100%). Overall agreement was 99.2% (95% CI: 97.5-100%). Discordant results were further evaluated using a third device (Scimedix).

Technological Characteristics

Solid-phase enzyme immunoassay (EIA) using polystyrene microwells coated with purified human thyroglobulin. Employs goat anti-human IgG conjugated with alkaline phosphatase. Detection via p-Nitrophenyl phosphate substrate conversion to a yellow end-product measured photometrically at 405 nm. Standardized to NIBSC values; results reported in IU/mL. Manual or automated photometric readout.

Indications for Use

Indicated for the quantitative detection of IgG antibodies to thyroglobulin in human serum to aid in the diagnosis of thyroid diseases, specifically Autoimmune Thyroiditis and Graves' disease. For in vitro diagnostic use only.

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

• Pharmacia Varelisa TG Antibodies (K023592)

Reference Devices

• Scimedix Anti-Thyroglobulin Test

Submission Summary (Full Text)

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APPENDIX 3.

| | 510(k) SUMMARY | K023592 |
|------------------------|---------------------------------------------------------------------------------------------|-------------|
| Applicant: | Quest International, Inc.<br>1938 N.E. 148th Terrace<br>North Miami, FL 33181 | FEB 06 2003 |
| Registration No. | 1061839 | |
| Contact Person: | Robert A. Cort, V.P., Quality Assurance | |
| Telephone: | [phone] | |
| Telefax: | [phone] | |
| Manufacturing Site: | Same as above | |
| Device: | SeraQuest® Anti-Thyroglobulin | |
| Device Name: | Anti-Thyroglobulin, Multiple autoantibodies immunological test system<br>(21CFR § 866.5660) | |
| Device Classification: | Class II (Performance Standards) | |

### Description:

The SeraQuest Anti-Thyroglobulin test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IqG antibodies which are directed against thyroglobulin, in human serum.

The Calibrators in the SeraQuest Anti-Thyroglobulin test kit have been assigned values based on the NIBSC standard. Test results are reported as international units per milliliter (IU/mL).

# Principle:

Diluted samples are incubated in wells coated with thyroglobulin antibodies directed against thvroolobulin antiqen (if present) are immobilized in the wells. Residual sample is eliminated by washing and draining, and coniugate (enzyme-labeled antibodies to human IgG) is added and incubated. If laG antibodies to thyroglobulin antigen are present, the conjugate will be immobilized in the wells. Residual conjugate is eliminated by washing and the enzyme substrate is added and incubated. In the presence of the enzyme, the substrate is converted to a vellow endproduct which is read photometrically at 405 nm.

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## itended Use:

Intended Use: The Anti-Thyroglobulin test is intended for the quantative detection of human IgG antibodies to thyroglobulin antigen, in human serum by enzyme immunoassay. The presence of antithyroglobulin antibodies can be used with other serological tests and clinical findings to aid in diagnosing individuals with Autoimmune Thyroditis and Grave's Disease. For In Vitro Diagnostic Use Only.

### Predicate Device:

The SeraQuest Anti-Thyroglobulin test is substantially equivalent in intended use and performance, to the Pharmcia Varelisa TG Antibodies, Freiburg, Germany.

# Summary of Technological Characteristics:

| Characteristic | SeraQuest<br>Anti-Thyroglobulin<br>Test | Pharmacia<br>Varelisa<br>TG Antibodies Test |
|--------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Description: | Enzyme Immunoassay | Enzyme Immunoassay |
| Intended Use: | The detection of IgG<br>antibodies against<br>thyroglobulin<br>in human serum. | The detection of IgG<br>antibodies against<br>thyroglobulin<br>in human serum. |
| Solid Phase: | Polystyrene Microwell | Polystyrene Microwell |
| Antigen : | Purified<br>thyroglobulin<br>(human) | Purified<br>thyroglobulin<br>(human) |
| Number of Incubation Periods: | Three | Three |
| Sample Dilution: | 1:51 | 1:101 |
| Sample Incubation<br>Duration: | 30 minutes | 30 minutes |
| Incubation Temperature: | Room temperature | Room temperature |
| Ezyme-labeled Conjugate: | | |
| Antibody | Goat anti-human IgG | Goat anti-human IgG |
| Enzyme | Alkaline phosphatase | Horse Radish Peroxidase |

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Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181 Page No. 75

| Conjugate Volume: | 100 μl | 100 μl |
|---------------------------------------------|------------------------------|-------------------------|
| Conjugate Incubation Duration: | 30 minutes | 30 minutes |
| Substrate: | p-Nitrophenyl<br>phosphate | TMB |
| Subtrate Volume: | 100 μl | 100 μl |
| Substrate Incubation Duration: | 30 minutes | 10 minutes |
| Stop Reagent: | 0.5 M Trisodium<br>phosphate | 0.34 M<br>Sulfuric acid |
| Stop Reagent Volume: | 100 μl | 50 μl |
| Readout: | Spectrophotometric | Spectrophotometric |
| Wavelength: 405 nm<br>Reference Wavelength: | 450 nm<br>620 nm | 450 nm |
| Normalization: | Standard Curve | Standard Curve |
| Reporting Unit: | IU / mL | IU / mL |

Summary of Clinical Testing:

APPENDIX 3.

# Experimental Procedure

To challenge the cutoff values. 144 serum specimens were tested at Quest International. Inc., concurrently by the SeraQuest Anti-Thyroglobulin test, and the Varelisa TG Antibodies test (Pharmacia & Upichn Diagnostics). The assays were performed and interpreted according to the instructions in the manufacturer's package inserts.

### Results and Conclusion

The qualitative agreement between the SeraQuest and the Pharmacia tests is shown in Table 1.

Of the 144 specimens tested, 33 were positive, 84 were equivocal in both the SeraQuest and Varelisa tests (please see Table C-3). Of the 21 specimens remaining, 1 specimen which was negative by the Varelisa test, was positive by the SeraQuest test; 14 specimens which ··ere negative in the SeraQuest test, were equivocal by the Varelisa test; and of the 6 which were Juivocal in the SeraQuest test, 4 were positive and 2 negative in the Varelisa test.

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Excluding the equivocal results, the sensitivity of the SeraQuest Anti-Thyroglobulin test relative to the Varelisa test was 97%, or 91.4% to 100% (95% C.I.); the specificity was 100%, or 99.9% to 100% (95% C.I.); respectively. The overall agreement was 99.2%, or 97.5% to 100% (95% C.I.).

### TABLE 1.

## RESULTS OF SeraQuest ANTI-THYROGLOBULIN ASSAYS AND PHARMACIA ANTI-THYROGLOBULIN ASSAYS ON 144 SERUM SPECIMENS.

| | SeraQuest | | | | | |
|-----------|-----------|-----|-----|-------------------------------------------|-------------|----------------------|
| PHARMACIA | POS | EQU | NEG | | % | 95% C.I. |
| POS | 33 | 4 | 1 | Relative Sensitivity | 97.0 | 91.4-100 |
| EQU | 0 | 6 | 14 | | | |
| NEG | 0 | 2 | 84 | Relative Specificity<br>Overall Agreement | 100<br>99.2 | 99.9-100<br>97.5-100 |

* Excluding equivocal results.

** 95%Confidence Interval calculated by the normal method.

The specimen which gave discordant result was tested by a second legally marketed device, the Scimedix Anti-Thyroglobulin Test, Scimedix Corp., Denville, New Jersey. The sample gave an equivocal result with the Scimedix test.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 0 6 2003

Mr. Robert A. Cort Vice President, Quality Assurance Quest International, Inc. 1938 N.E. 148th Terrace North Miami, FL 33181

Re: k023592

Trade/Device Name: SeraQuest Anti Thyroglobulin Regulation Number: 21 CFR 866.5870 Regulation Name: Thyroid Autoantibody Immunological Test System Regulatory Class: Class II Product Code: DDC Dated: December 23, 2002 Received: December 24, 2002

Dear Mr. Cort:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 –

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL. 33181 Page No.

#### APPENDIX 6

Page _ -

510(k) Number (if known): K 023592

Device Name: SeraQuest Anti-Thyroglobulin

Indications For Use:

- 1. For the quantitative detection of IqG antibodies to thyroglobulin in human serum by enzyme immunoassay.
- 2. The SeraQuest Anti-thyroglobulin test can be used with other serological tests and clinical findings, to aid in the diagnosis of thyroid diseases such as Autoimmune Thyroiditis and Graves' disease.
- ર્જ For in vitro diagnostic use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

*Pleeves for S. Bautista*
(Division Sign-Off)'
Division of Clinical Laboratory Devices
510(k) Number K023592

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use***_***_

(Optional Format 1-2-96)