(63 days)
Not Found
No
The device description and performance studies focus on a standard chemiluminescence immunoassay method, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is an immunoassay intended for quantitative determination of autoantibodies for diagnostic purposes, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use in the diagnosis of Hashimoto's and Graves' autoimmune diseases affecting the thyroid gland."
No
The device description clearly outlines a competitive chemiluminescence immunoassay involving physical reagents, incubation steps, washing, and measurement of chemiluminescence using a luminometer. This is a laboratory-based assay with hardware components (analyzer, luminometer) and chemical reagents, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is for the "quantitative determination of autoantibodies against thyroglobulin (TG) in human serum and plasma". This involves testing biological samples (serum and plasma) in vitro (outside the body).
- Purpose: The intended use also states it is "for use in the diagnosis of Hashimoto's and Graves' autoimmune diseases affecting the thyroid gland." This clearly indicates a diagnostic purpose.
- Device Description: The description details a "competitive, chemiluminescence immunoassay" performed on "human serum and plasma". This is a laboratory-based test using reagents to analyze components of a biological sample.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / 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 intended as an aid in the diagnosis of Hashimoto's and other autoimmune diseases affecting the thyroid gland.
Product codes (comma separated list FDA assigned to the subject device)
JZO
Device Description
The ACS:180 and ADVIA Centaur anti-Tg are a competitive chemiluminescence immunoassay intended for the quantitative determination of autoantibodies against thyroglobulin in human serum and plasma. A polyclonal human anti-Tg antibody is bound to a solid phase (paramagnetic particles) or to a solid phase (bead). Calibrators, controls, and patient samples are incubated with labeled native human thyroglobulin (the Lite reagent). Following incubation, unreacted labeled thyroglobulin is removed. The chemiluminescence of the reacted, labeled thyroglobulin is measured in a luminometer. The amount of chemiluminescence is inversely proportional to the concentration of anti-thyroglobulin antibody in the sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Thyroid gland
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison:
Comparison of the ACS:180 anti-Tg to the predicate device DYNOtest anti-Tg, (K992790).
Comparison of the ADVIA Centaur to the ACS:180 used transference.
Substantial equivalence to the DYNOTest kit, cleared under K992790, is based on clinical comparison of the productions with Graves' disease using 56 serum samples from normal blood donors (1200) and proof based on a 2 X 2 agreement table was 286/293 = 97.6%.
ACS:180 vs. DYNOtest:
- Normal patients:
- Sample size: 293 (23 positive, 270 negative by DYNOtest)
- Agreement = 97.6% (286/293)
- Graves patients:
- Agreement = 87.9% (87/99)
- Hashimoto's patients:
- Sample size: 189 (133 positive, 56 negative by DYNOtest)
- Agreement = 70.9% (134/189)
The sensitivity of the ACS:180 anti-Tg assay is greater than 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 is: ADVIA Centaur anti-Tg = 1.03 (ACS:180 anti-Tg) + 2.29 U/mL.
- Correlation Coefficient ( r ) = 0.989.
- Diagnostic concordance between the two assays: using 255 samples, % Agreement = 98% (250/255).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
ACS:180 vs. DYNOtest:
- Normal patients:
- % Agreement = 97.6 (286/293)
- Graves patients:
- % Agreement = 87.9 (87/99)
- Hashimoto's patients:
- % Agreement = 70.9 (134/189)
- Sensitivity of ACS:180 for Graves: 39.9% vs. 29.3% for DYNOTest.
- Sensitivity of ACS:180 for Hashimoto: 70.4% vs. 41.2% for DYNOTest.
ADVIA Centaur vs. ACS:180:
- Correlation Coefficient ( r ) = 0.989
- % Agreement = 98% (250/255)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.5870 Thyroid autoantibody immunological test system.
(a)
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.(b)
Classification. Class II (performance standards).
0
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 |
| 511 Benedict Ave. | |
| Tarrytown, NY 10591 | |
| Phone: (914) 524-2446 | |
| FAX: (914) 524-2500 | |
| e-mail: ken.edds.b.@bayer.com | |
| Date Summary Prepared: | July 17, 2001 |
| 2. Device Information | |
| Proprietary Name: | ADVIA Centaur and ACS:180 anti-Tg |
| 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:
1
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%.
2
ACS:180 vs. DYNOtest
Normal patients:
DYNOtest anti-Tgn
| Positive | Negative | |
|---|---|---|
| ACS:180 anti-Tg | ||
| Positive | 23 | 7 |
| Negative | 0 | 263 |
| % Agreement = 97.6 (286/293) |
Graves patients:
DYNOtest anti-Tgn
| -------------- | ||
|---|---|---|
| ------------- | ||
| **** | --------- | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ||
| ----------- | ||
| 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)
3
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.
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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
5
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) | |
|---|---|
| --------------------------------------- | ----------------------------------------------- |
OR
| Over-The-Counter Use (Optional Format 1-2-96) | |
|---|---|
| ----------------------------------------------- | -- |
| Sousan S. Altaie | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K012777 |