(61 days)
Not Found
No
The summary describes a standard immunoassay using electrochemiluminescence detection and a calibration curve, with no mention of AI or ML terms or concepts.
No.
The device is an immunoassay for in vitro quantitative determination of antibodies, used as an aid in detection, not for treatment.
Yes
The device determines antibodies to thyroglobulin to aid in the detection of autoimmune thyroid diseases, which is a diagnostic purpose.
No
The device is an immunoassay kit, which is a laboratory test involving chemical reagents and hardware (analyzers), not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "Immunoassay for the in vitro quantitative determination of antibodies to thyroglobulin in human serum and plasma." The phrase "in vitro" is a key indicator of an IVD.
- Sample Type: The assay uses human serum and plasma, which are biological samples tested outside of the body.
- Purpose: The determination of anti-Tg antibodies is used as an aid in the detection of autoimmune thyroid diseases, which is a diagnostic purpose.
- Technology: The description mentions an "electrochemiluminescence Immunoassay," which is a common technique used in IVD testing.
- Analyzers: The assay is intended for use on specific laboratory analyzers (Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170), which are typically found in clinical laboratories for IVD testing.
N/A
Intended Use / Indications for Use
Immunoassay for the in vitro quantitative determination of antibodies to thyroglobulin in human serum and plasma. The anti-Tg determination is used as an aid in the detection of autoimmune thyroid diseases. The electrochemiluminescence Immunoassay “ECLIA” is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.
Product codes
JZO
Device Description
The Elecsys Anti-Tg Assay is a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve provided with the reagent bar code.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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FEB 7 2006
510(k) Summary - Elecsys Anti-Tg
According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence Roche Diagnostics Submitter name, address, 9115 Hague Rd contact Indianapolis IN 46250 (317) 521-3532 Contact person: Randy Johnson Date prepared: December 7, 2005 Device name Proprietary name: Roche Diagnostics Elecsys Anti-Tg Common name: Anti-Thyroid Antibodies Classification name: Thyroid Autoantibody Immunological Test System Device The Elecsys Anti-Tg Assay is a two step sandwich immunoassay with description streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve provided with the reagent bar code. ANNE AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND A Continued on next page
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| Intended use | Immunoassay for the in vitro quantitative determination of antibodies to thyroglobulin in human serum and plasma. The anti-Tg determination is used as an aid in the detection of autoimmune thyroid diseases. The electrochemiluminescence Immunoassay “ECLIA” is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers. |
|---|---|
| Predicate device | The Elecsys Anti-Tg is equivalent to other devices legally marketed in the United States. We claim equivalence to the Elecsys Anti-Tg (K020672). |
Continued on next page
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Device comparison The table below compares the Elecsys Anti-Tg (K020672) and the Elecsys Anti-Tg (modified device).
| Topic | Elecsys Anti-Tg
(K020672) | Elecsys Anti-Tg
(Modified Device) |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Intended use | Immunoassay for the in vitro
quantitative determination of
antibodies to thyroglobulin in human
serum and plasma. The anti-Tg
determination is used as an aid in the
detection of autoimmune thyroid
diseases. The
electrochemiluminescence
Immunoassay "ECLIA" is intended
for use on the Roche Elecsys
1010/2010 and MODULAR
ANALYTICS E170 (Elecsys module)
immunoassay analyzers. | Same |
| Sample type | Human serum
Human plasma treated with sodium
heparin, or K2/K3-EDTA | Same |
| Assay Protocol | Competitive assay | Same |
| Detection
Protocol | Electrochemiluminescence
immunoassay | Same |
| Traceability | Calibrated against NIBSC 65/93
Standard | Same |
Continued on next page
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Device comparison, continued
The table below compares the Elecsys Anti-Tg (K020672) and the Elecsys Anti-Tg (modified device).
and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the commen
| Topic | Elecsys Anti-Tg
(K020672)
CALIBRATORS | Elecsys Anti-Tg
(Modified Device) |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Matrix | Human serum matrix
Origin of Anti-Tg antibodies:
Cal1: Human
Cal2: Human (Note: Human was
incorrectly listed in the package insert
upon submission. Cal2 was of sheep
origin at the time of the submission.) | Same
Origin of Anti-Tg antibodies:
Call: Same
Cal2: Sheep (Note: Correction of the
error in the package insert from the
K020672 filing) |
| Storage form | Calibrator: Liquid | Calibrator: Lyophilized |
| Target values | Cal 1: 40 IU/mL
Cal 2: 3,250 IU/mL | Same |
| Stability | Unopened at 2 - 8°C:
Up to the stated expiration date
After opening:
8 weeks at 2 - 8°C
On Elecsys 1010/2010 analyzer:
Up to 5 hours at 20 - 25°C
On E170: Use once only | Lyophilized:
Up to the stated expiration date
Reconstituted:
6 weeks at 2 - 8°C
On Elecsys 1010/2010 at 20 - 25°C:
Up to 5 hours
On MODULAR ANALYTICS E170:
Use only once |
| Filling volume | 1.3 mL | 1.5 mL |
| Topic | Elecsys Anti-Tg (K020672) | Elecsys Anti-Tg (Modified Device) |
| | REAGENTS | |
| Stability | Unopened at 2 - 8°C:
Up to the stated expiration date
After opening:
12 weeks at 2 - 8°C
On E170/Elecsys 2010: 6 weeks
On Elecysys 1010: 6 weeks (stored
alternately in the refrigerator and on
the analyzer - ambient temperature 20
- 25°C; up to 20 hours opened in total) | Unopened at 2 - 8°C:
Up to the stated expiration date
After opening at 2 - 8°C:
6 weeks (Harmonized to calibrator
stability claim)
On MODULAR ANALYTICS E170:
6 weeks
On Elecsys 2010: 6 weeks
On Elecsys 1010: 6 weeks (stored
alternately in the refrigerator and on
the analyzer - ambient temperature 20
- 25°C; up to 20 hours opened in total) |
| Reagent 2 (R2) | Monoclonal anti-Tg antibodies
(human) labeled with ruthenium
complex 0.520 mg/L | Monoclonal anti-Tg antibodies
(human) labeled with ruthenium
complex 0.620 mg/L |
| | CONTROLS | |
| Stability | Unopened at 2 - 8°C:
Up to the stated expiration date
PC A-Tg1, PC A -Tg2, after opening:
8 weeks at 2 - 8°C
On Elecsys 1010/2010 analyzers: up
to 5 hour at 20 - 25°C
On E170: use once only | Unopened at 2 - 8°C:
Up to the stated expiration date
PC A-TG1, PC A-TG2, after opening:
6 weeks at 2 - 8°C (Harmonized to
calibrator stability claim)
On Elecsys 1010/2010 at 20 - 25°C:
Up to 5 hours
On MODULAR ANALYTICS E170:
Use only once |
Continued on next page
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Device comparison, continued
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The table below compares the Elecsys Anti-Tg (K020672) and the Elecsys Anti-Tg (modified device).
のお得ないので、その他のお気になる。
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/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 tail feathers. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 7 2006
Roche Diagnostics Corp. c/o Randy J. Johnson MT (ASCP) Regulatory Affairs Consultant 9115 Hague Rd. Indianapolis, IN 46250
Re: K053426
Trade/Device Name: Roche Diagnostics Elecsys Anti-Tg Regulation Number: 21 CFR 866.5870 Regulation Name: Thyroid autoantibody immunological test system Regulatory Class: Class II Product Code: JZO Dated: December 7, 2005 Received: December 8, 2005
Dear Mr. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 910(t) production is substantially equivalent (for the indications for referenced above and have acterially marketed predicate devices marketed in interstate commerce use stated in the eneround to regard date of the Medical Device Amendments, or to devices that prior to May 26, 1770, inc onceentine ask the provisions of the Federal Food, Drug, and Cosmetic liave been receasined in are approval of a premarket approval application (PMA). You may, ACC (ACC) that ao not require apple for the general controls provisions of the Act. The general therefore, market the detrice, sacfoot, we animents for annual registration, listing of devices, good controls provisions of misters, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be Illay be subject to such additions. 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 r lease be advised that I Dri 3 isounted on a sodenies complies with other requirements of the Act or that FDA has made a dolornination 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); an the Act 3 requirements, morading, practice requirements as set forth in the quality labeling (21 CFR Part 800); 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 Section 510(k) I his letter will anow you to begin mailteing of substantial equivalence of your device to a legally premarket notification: "The PDF mailing of Cation 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), please If you desire specific advice for your don't to may be as note the regulation entitled, comact the Other of Comphance as (210) for Part 807.97). You may obtain other IMISoraniumig of reference to promaibilities under the Act from the Division of Small general information on your responsionner Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Consultive views.fda.gov/cdrh/industry/support/index.html.
Sincercly yours,
Robert H. Becker, Jr.
Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Elecsys Anti-Tg
Indications For Use:
Immunoassay for the in vitro quantitative determination of antibodies to thyroglobulin in human serum and plasma. The anti-Tg determination is used as an aid in the detection of autoimmune thyroid diseases. The electrochemiluminescence Immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.
Prescription Use XXXX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mana Chan
Division Sign-Off
Office ef this in Diagnostic Device Evaluation mot houry
Confidential
510(k)_ 405 3426
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