ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895

K012208 · Beckman Coulter, Inc. · DDC · Sep 7, 2001 · Immunology

Device Facts

• Record ID: K012208
• Device Name: ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895
• Applicant: Beckman Coulter, Inc.
• Product Code: DDC · Immunology
• Decision Date: Sep 7, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5870
• Device Class: Class 2

Intended Use

The Access Thyroglobulin Antibody (TgAb) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access® Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease, nontoxic goiter, and Graves' disease.

Device Story

The Access Thyroglobulin Antibody assay is an in vitro diagnostic test performed on the Access Immunoassay System. It utilizes a paramagnetic particle, chemiluminescent immunoassay (sandwich format) to measure thyroglobulin autoantibodies in human serum or plasma. The system is intended for use in clinical laboratory settings by trained personnel. The device automates the immunoassay process, utilizing a stored calibration curve to quantify antibody levels. Healthcare providers use the resulting quantitative values to assist in the clinical diagnosis of thyroid disorders. The automated nature of the system provides improved efficiency and standardization compared to manual radioimmunoassay methods.

Clinical Evidence

Bench testing only. Analytical sensitivity was 2.2 IU/mL. Precision studies showed total imprecision of 4.47-6.74% CV. Method comparison with 276 samples against the predicate showed a correlation coefficient of r=0.816. Relative sensitivity and specificity were 79.0% and 87.6% respectively, based on 296 samples (Graves', Hashimoto's, and normal). No significant interference from common contaminants was observed.

Technological Characteristics

Paramagnetic particle, chemiluminescent sandwich immunoassay. Automated system. Standardized against NIBSC Anti-Thyroglobulin Serum (WHO 65/93). Measuring range 2.2-2500 IU/mL. Sample type: serum or plasma. Reagent stability: 56 days. Calibration: stored curve.

Indications for Use

Indicated for the quantitative determination of thyroglobulin antibody levels in human serum and plasma to aid in the diagnosis of thyroid disorders including Hashimoto's disease, nontoxic goiter, and Graves' disease.

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

• Kalibre-RTM Thyroglobulin Antibody (TgAb) RIA Kit (K894203)

Submission Summary (Full Text)

{0}------------------------------------------------

K012208

SEP = 7 2001

Image /page/0/Picture/2 description: The image shows the logo for Beckman Coulter. The logo consists of a circular graphic on the left and the company name "BECKMAN COULTER" on the right. The circular graphic features a stylized design with curved lines and small dots, resembling a globe or planet. The text is in a bold, sans-serif font, with "BECKMAN" stacked above "COULTER".

1.5

#### 510(k) Summary · Prepared July 12, 2001

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K012208

#### Submitter's Name and Address

Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318

Denise Thompson Primary Contact: [phone]

Alternate Contact: Brent Taber [phone]

#### Device Name

Trade Name:

Access® Thyroglobulin Antibody for use on the Access® Immunoassay Systems

Thyroglobulin Antibody Enzyme Immunoassay Common Name: Classification name: Immunochemical, Thyroglobulin Autoantibody

#### Predicate Device

Kalibre-RTM Thyroglobulin Antibody (TgAb) RIA Kit Kronus / Boise Research Center Boise, ID 83713

510(k) Number: K894203

#### Device Description

The Access Thyroglobulin Antibody reagents, Thyroglobulin Antibody calibrators, and the Access Immunoassay Analyzer comprise the Access Immunoassay System for the quantitative determination of thyroglobulin antibody in human serum and plasma.

#### Intended Use

The Access Thyroglobulin Antibody (TgAb) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease, nontoxic goiter, and Graves' disease.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a circular graphic to the left of the company name. The graphic is black with white dots and two white curved lines running through the center. The company name, "BECKMAN COULTER", is written in a bold, sans-serif font to the right of the graphic.

: .... .

# Comparison of Technological Characteristics

. . . . .

| Parameter | Access AccuTnl | Dimension RxL TROP |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Access® Thyroglobulin<br>Antibody (TgAb) assay is a<br>paramagnetic particle,<br>chemiluminescent<br>immunoassay for the<br>quantitative determination of<br>thyroglobulin antibody levels<br>in human serum and plasma<br>using the Access®<br>Immunoassay Systems. The<br>measurement of thyroid<br>autoantibodies may aid in the<br>diagnosis of certain thyroid<br>disorders, such as<br>Hashimoto's disease, nontoxic<br>goiter, and Graves' disease. | The KRONUS<br>Thyroglobulin Antibody kit<br>quantitatively measures<br>human serum<br>autoantibodies to<br>thyroglobulin antigen.<br>Serve as an aid in the<br>diagnosis of certain thyriod<br>disorders, such as<br>Hashimoto's thyroiditis,<br>non-toxic goiter and<br>Graves' Disease. |
| Analyte<br>Measured | Thyroglobulin Antibody | Thyroglobulin Antibody |
| Standarization | NIBSC Anti-Thyroglobulin<br>Serum, Human First<br>International Reference<br>Preparation, WHO Coded<br>65/93 | NIBSC Anti-Thyroglobulin<br>Serum, Human First<br>International Reference<br>Preparation, WHO Coded<br>65/93 |
| Technology | Sandwich immunoassay | Sandwich immunoassay |
| Format | Chemiluminescent<br>Immunoassay | Radioimmunoassay |
| Method | Automated | Manual |
| Calibration | Utilizes a stored calibration<br>curve | Requires calibration with<br>every run |
| Sample type | Serum or plasma | Serum only |
| Measuring range | 2.2-2500 IU/ml | 0.3-30 U/ml (3-300 IU/ml) |

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a circular graphic on the left and the company name "BECKMAN COULTER" on the right. The circular graphic is black with white dots and two white curved lines inside. The text is in a bold, sans-serif font, with "BECKMAN" stacked above "COULTER".

### Summary of Studies

Analytical Specificity: There was no significant interference from potential sample contaminants (total protein, bilirubin, hemoglobin, and triglycerides). Additionally, only one discrepancy between interpretations positive and negative was found between the Access and Kronus thyroglobulin assays for samples form persons with autoimmune disease.

Analytical Sensitivity: The lowest detectable level of thyroglobulin antibody distinguishable from zero (Access Thyroglobulin Calibrator Zero) with 95% confidence was determined to be 1.5 IU/mL. An analytical sensitivity of 2.2 IU/mL will be used in the Access Thyroglobulin Antibody labeling.

Dilution Recovery: Various dilutions of serum samples and serum sample pools were analyzed. The overall mean recovery of the samples was 95% with individual mean sample recoveries varying between 90% and 100%.

Precision: Within run imprecision ranged from 3.99 to 5.04 % CV, between run imprecision ranged from 1.95 to 4.66 % CV, and total imprecision ranged from 4.47 to 6.74 % CV at levels ranging between 34.1 and 1,693 IU/ml.

Hook Effect: The Access Thyroglobulin Antibody assay demonstrated no hook to 350,000 IU/ml.

Relative Sensitivity and Specificity: A total of 296 serum samples (99 with Graves' disease, 97 with Hashimoto's disease, and 100 normals) were used to calculate relative sensitivity and specificity for the Access vs. the Kronus thyroglobulin antibody assays. The study showed good relative sensitivity (79.0%) and relative specificity (87.6%) between the methods.

Method Comparison: A comparison of thyroglobulin antibody values from 276 samples, ranging from approximately <2.2 to 284 IU/ml, were run with both the Access Thyroglobulin Antibody immunoassay and the Kronus Thyroglobulin Antibody immunoradiometric assay. The study demonstrated a correlation coefficient of r = 0.816, a slope of y = 0.957, and an intercept of -5.886.

Stability: The Access Thyroglobulin Antibody reagents are stable for 56 days after opening. The calibration curve is also stable for 56 days.

#### Conclusion

The Access Thyroglobulin Antibody assay, for use on the Access Immunoassay Systems, is substantially equivalent to another test currently in commercial distribution for the measurement of thyroglobulin antibody.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 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 a stylized image of a bird.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# SEP = 7 2001

Ms. Denise Thompson Regulatory Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318-1084

K012208 Re:

Trade/Device Name: The Access® Thyroglobulin Antibody assay for use on the Access® Immunoassay Systems Regulation Number: 21 CFR 866.5870 Regulation Name: Thyroid Autoantibody Immunological Test System Regulatory Class: II Product Code: DDC Dated: July 12, 2001 Received: July 16, 2001

Dear Ms. Thompson:

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 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 Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{4}------------------------------------------------

Page 2 -

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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

## 1.6 INDICATIONS FOR USE STATEMENT

Page _________________________________________________________________________________________________________________________________________________________________________ of 1

## 510(k) Number (if known): K012208

Device Name: The Access® Thyroglobulin Antibody assay for use on the Access® Immunoassay Systems.

#### Indications For Use:

The Access Thyroglobulin Antibody (TgAb) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access® Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease, nontoxic goiter, and Graves' disease.

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

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

Donald J. Horn

(Division Sign-Off) (Division of Cumical Laboratory Devices KG12208 510(k) Number _

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The Counter Use_

(Optional Format 1-2-96)