ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS

K012777 · Bayer Corp. · JZO · Oct 22, 2001 · Immunology

Device Facts

• Record ID: K012777
• Device Name: ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS
• Applicant: Bayer Corp.
• Product Code: JZO · Immunology
• Decision Date: Oct 22, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5870
• Device Class: Class 2

Indications for Use

The ACS:180 and ADVIA Centaur anti-Tg Immunoassays are competitive, chemiluminescence immunoassay for the quantitative determination of autoantibodies against thyroglobulin (TG) in human serum and plasma for use on the automated analyzer marketed by Bayer Corporation. The ACS:180 and ADVIA Centaur anti-Tg immunoassays are indicated in the diagnosis of Hashimoto's and autoimmune diseases affecting the thyroid gland.

Device Story

Competitive chemiluminescence immunoassay; detects autoantibodies against thyroglobulin in human serum/plasma. Input: patient sample; reagent containing labeled native human thyroglobulin. Process: polyclonal human anti-Tg antibodies in sample compete with labeled thyroglobulin for binding sites; incubation; separation of unreacted components; measurement of chemiluminescence in luminometer. Output: quantitative concentration of anti-thyroglobulin antibodies. Used in clinical laboratories on automated analyzers (ACS:180 or ADVIA Centaur). Healthcare providers use results to assist in diagnosing autoimmune thyroid conditions like Hashimoto's disease. Benefits include automated, high-throughput testing replacing manual 125I-based assays.

Clinical Evidence

Clinical comparison study using 561 serum samples. Compared ACS:180 anti-Tg to predicate DYNOTest anti-Tg. Agreement: 97.6% (286/293) for normal donors, 87.9% (87/99) for Graves' disease, and 70.9% (134/189) for Hashimoto's patients. Sensitivity of ACS:180 was higher than predicate (39.9% vs 29.3% for Graves; 70.4% vs 41.2% for Hashimoto). ADVIA Centaur vs. ACS:180 correlation (n=255) showed r=0.989 and 98% agreement.

Technological Characteristics

Competitive chemiluminescence immunoassay. Solid phase: automated analyzer. Signal: chemiluminogenic acridinium ester label. Reagents: polyclonal human anti-Tg antibodies and labeled native human thyroglobulin. Connectivity: automated analyzer system. Sterilization: N/A (in vitro diagnostic reagent).

Indications for Use

Indicated for the quantitative determination of anti-thyroglobulin (TG) autoantibodies in human serum and plasma to aid in the diagnosis of Hashimoto's thyroiditis and other autoimmune thyroid diseases.

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

• DYNOTest anti-Tg (K992790)

Submission Summary (Full Text)

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# K012777

OCT 22 2001

## Bayer Diagnostics

# ASC:180 and ADVIA Centaur anti-Tg Immunoassays Section 2: Summary of Safety and Effectiveness

As required by 21 CFR 807.92, the following 510(k) Summary is provided:

## 1. Submitter Information

| Contact person: | Kenneth T. Edds Ph.D |
|---------------------------------|-------------------------------------------------------------------------------|
| Address: | Bayer Diagnostics Corporation<br>511 Benedict Ave.<br>Tarrytown, NY 10591 |
| | Phone: [phone]<br>FAX: [phone]<br>e-mail: [e-mail] |
| Date Summary Prepared: | July 17, 2001 |
| 2. Device Information | |
| Proprietary Name: | ADVIA Centaur and ACS:180 anti-Tg<br>Immunoassay |
| Common Name: | anti-Tg Immunoassay |
| Classification Name: | Thyroid autoantibody immunological test system |
| Class: | Class II |
| CFR: | 21 CFR 866.5870 |
| Product Code: | JZO |
| 3. Predicate Device Information | |

DYNOTest® anti-Tgn Name: BRAHMS Diagnostica, GmbH Manufacturer: Neuendorfstrasse 25 D-16761 Hennigsdorf Germany

510(k) Number:

K992790

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## 4. Device Description

The ACS:180 and ADVIA Centaur anti-Tg are a competitive chemiluminescence immunoassay The ACS:180 and ADVIA Centaur anti-1 g are a tounist throughbulin in human serum
intended for the quantitative determination of autoantibodies against trying and intended for the quantitiative delemination of backlessing masters with and and plasma. A polyclonal human anti-1 g antibus bounds, and controls for directly
autoimmune anti-thyroglobulin antibodies in patient samples, standards and label autommune anni-inylogiouin antibodies in pation. Following incubation, unreacted labeled
labeled native human thyroglobulin the lite reagent. Following incubation mixtu labeled hative numan thyroglobulin the liter reagent. The reaction mixture. The thyroglobulin and unreacted antibodies from the outliple are neasured in a luminometer. The chemiluminescence of the reacted, labeled thyrogiousline in anti-hyroglobulin antibody in the sample.

### 5. Statement of Intended Use

The ACS:180 and ADVIA Centaur anti-Tg Immunoassays are competitive, chemiluminescence The ACS:180 and ADVIA Centrali ann-19 intribution of autoanist theronobulin (TG) in human
immunoassay for the quantitative determination of autoantibooking The ACS: 180 immunoassay for the quantitative detemmation or advantised by Bayer Corporation. The ACS: 180
serum and plasma for use on the automated analyzer markets of Hechimoto's and serum and plasma for use on the automated analyzed in the diagnosis of Hashimoto's and and ADVIA Oontaar ammmune diseases affecting the thyroid gland.

## 6. Summary of Technological Characteristics

The ACS:180 and ADVIA Centaur anti-Tg Immunoassays are similar to the BRAHMS Diagnostica The ACS.100 and ADVIA Oentain and Tig mind on tor use, format, solid phase, performance DYNOTestle anti-10 Kit (K992790) in the indications for accept official stimati-Ty tests differ from the predicate characteristics, and results. The ROO. For and ADVA ( so compared to a manual coated tube device in their lifeended use on an addiness as company as a company and the many is used to
technique. In the automated methods, a chemiluminogenic molecule (acridinium es replace the 1251 signal used in the DYNOTest anti-Tg manual assay.

### 7. Method Comparison

The data represented in this document is organized into two components:

- e data represented in this document to organized into device DYNOtest anti-Tg, (K992790).
Comparison of the ACS:180 anti-Tg to the predicate device DYNOtest anti-Tg, (K99279 1. Results in sections 3 & 4.
- Results in sections S & 4.
Comparison of the ADVIA Centaur to the ACS:180 used transference. Transference is a method Companson of the ADVIA Centadi to the AOC. For association the Clinical Laboratory.
recommended by NCCLS (C28-A, How to Define Reference Intervals in the Clinical Laboratores recommended by NCCLS (O20-A, How to Boline no provides guidelines for transference of Street pother of Approved Guldelife). This document diseased by a different analytical system, different method or different instrument. Results are in section 5.

Substantial equivalence to the DYNOTest kit, cleared under K992790, is based on clinical comparison Substantial equivalence to the DTNOT of the Productions with Graves' disease using 56 i seruin samples from normal blood donors (1 200) and proup based on a 2 X 2 agreement table was 286/293 = 97.6%.

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#### ACS:180 vs. DYNOtest

#### Normal patients:

#### DYNOtest anti-Tgn

| | Positive | Negative |
|------------------------------|----------|----------|
| ACS:180 anti-Tg<br>Positive | 23 | 7 |
| Negative | 0 | 263 |
| % Agreement = 97.6 (286/293) | | |

Graves patients:

#### DYNOtest anti-Tgn

| -------------- | | |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | | |
| -------------<br>**** | ---------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| | -----------<br>01 A oursement == 07 0 /07/00) | |

% Agreement = 87.9 (87/99)

#### Hashimoto's patients:

#### DYNOtest anti-Tgn

| | | Positive | Negative |
|------------------------------|----------|----------|----------|
| ACS:180 anti-Tg | Positive | 78 | 55 |
| | Negative | 0 | 56 |
| % Agreement = 70.9 (134/189) | | | |

This correlation study demonstrates that the ACS:180 anti-Tg assay is substantially equivalent to the legally marketed predicate device, the BRAHMS Diagnostica DYNOTest anti-Tg assay; 510(k) legally mumotod proditor are the one it thyroid normals. The sensitivity (more diseased patients found positive) of the ACS: 180 anti-Tg assay is greater the BRAHMS Diagnostica DYNOTest anti-Tg assay; 39.9% vs. 29.3% for Graves and 70.4% vs. 41.2% for Hashimoto, respectively.

### ADVIA Centaur vs. ACS:180

For 255 serum samples in the range of 10 to 500 U/mL, the relationship between the ADVIA Centaur anti-Tg assay and the ACS:180 anti-Tg assay is described by the equation:

ADVIA Centaur anti-Tg = 1.03 (ACS:180 anti-Tg) + 2.29 U/mL Correlation Coefficient ( r ) = 0.989

The diagnostic concordance between the two assays is shown in the following table:

| | | ACS:180 anti-Tg | |
|-----------------------|----------|-----------------|----------|
| | | Positive | Negative |
| ADVIA Centaur anti-Tg | Positive | 110 | 4 |
| | Negative | 1 | 140 |

% Agreement = 98% (250/255)

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three overlapping profiles facing to the right, resembling a family or group of people.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 22 2001

Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097

Re: K012777

> Trade/Device Name: Bayer Diagnostics ACS:180 and ADVIA Centaur anti-Tg Assay Regulation Number: 21 CFR § 866.5870 Regulation Name: Thyroid Autoantibody Immunological Test System Regulatory Class: II Product Code: JZO Dated: August 15, 2001 Received: August 20, 2001

Dear Dr. Edds:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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#### 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 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 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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Page ***_ of _***

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Bayer Diagnostics ACS:180 and ADVIA Centaur anti-Tg Assay

#### Indications for Use:

The ACS:180 and ADVIA Centaur anti-Tg Immunoassays are competitive, chemiluminescence The ACS:180 and ADVIA Centaur and TV inimulodies against throglobulin (TG) in human
immunoassay for the quantitative determination of autoantibodies against Corporation, The immunoassay for the quantialive delemination of acreation of Bayer Corogration. The ACS:180
serum and plasma for use on the automated analyzer marketed by Bayer of Hochimoto' serum and plasma for use on the adloniated andy of the diagnosis of Hashimoto's and and ADVIA Centadi and 19 initifatioussalys are are are a faction the thyroid gland.

# (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) | <div> <img alt="Tick" src="tick.png"/> </div> |
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OR

| Over-The-Counter Use (Optional Format 1-2-96) | |
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| | Sousan S. Altaie |
|---------------|-----------------------------------------|
| | (Division Sign-Off) |
| | Division of Clinical Laboratory Devices |
| 510(k) Number | K012777 |