(23 days)
No
The description details a standard immunoassay based on electrochemiluminescence and a calibration curve, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
This device is an in vitro diagnostic immunoassay used to aid in the diagnosis of autoimmune thyroid diseases by quantitatively determining antibodies, not to treat a condition.
Yes
The device is described as "an aid in the diagnosis of autoimmune thyroid diseases," indicating its use in determining a medical condition.
No
The device description clearly outlines a system based on a competitive immunoassay with streptavidin microparticles and electrochemiluminescence detection, which are physical components and processes, not solely software.
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 Elecsys Anti-TPO immunoassay is "for the in vitro quantitative determination of antibodies to thyroid peroxidase in human serum and plasma." The phrase "in vitro" is a key indicator of an IVD.
- Purpose: The intended use also states that the determination is used "as an aid in the diagnosis of autoimmune thyroid diseases." This indicates the device is used to analyze samples taken from the human body to provide information for diagnostic purposes.
- Sample Type: The device analyzes "human serum and plasma," which are biological samples taken from a patient.
- Technology: The "Device Description" describes an "electrochemiluminescence immunoassay," which is a common technology used in IVD tests to detect and measure substances in biological samples.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Immunoassay for the in vitro quantitative determination of antibodies to thyroid peroxidase in human serum and plasma. The anti-TPO determination is used as an aid in the diagnosis 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.
The Elecsys Anti-TPO immunoassay is for the in vitro quantitative determination of antibodies to thyroid peroxidase in human serum and plasma. The anti-TPO determination is used as an aid in the diagnosis 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 COBAS Elecsys® Anti-TPO Test System is based on a competitive immunoassay with streptavidin microparticles and electrochemiluminescence detection. First and second incubations are nine minutes in duration. The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode, unbound substances are removed. Voltage is applied to the electrode inducing chemiluminescent emission which is measured by a photomultiplier. 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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).
0
AUG 4 - 2005
510(k) Summary - COBAS Elecsys® anti-TPO
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence |
|---|---|
| Submitter name, address, contact | Roche Diagnostics |
| 9115 Hague Rd | |
| Indianapolis IN 46250 | |
| (317) 521-3544 | |
| Contact person: Kay A. Taylor | |
| Date prepared: July 11, 2005 | |
| Device Name | Proprietary name: Roche Diagnostics COBAS Elecsys® Anti-TPO |
| Common name: anti-TPO Assay | |
| Classification name: System, Test, Thyroid Autoantibody | |
| Device description | The COBAS Elecsys® Anti-TPO Test System is based on a competitive immunoassay with streptavidin microparticles and electrochemiluminescence detection. First and second incubations are nine minutes in duration. The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode, unbound substances are removed. Voltage is applied to the electrode inducing chemiluminescent emission which is measured by a photomultiplier. 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. |
1
510(k) Summary - COBAS Elecsys® anti-TPO, continued
| Intended use | Immunoassay for the in vitro quantitative determination of antibodies to
thyroid peroxidase in human serum and plasma. The anti-TPO determination
is used as an aid in the diagnosis 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 COBAS Elecsys® Anti-TPO Test System is equivalent to other devices
legally marketed in the United States. We claim equivalence to the Elecsys
Anti-TPO (K000155). |
| Device
Comparison | The table below illustrates the similarities between the Elecsys Anti-TPO
(K000155) and the COBAS Elecsys Anti-TPO (modified device). |
| Topic | Elecsys® Anti-TPO
(K000155) | COBAS Elecsys® Anti-TPO
(Modified Device) |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Intended use | for the quantitative determination of
antibodies to thyroid peroxidase in
human serum and plasma. | same |
| Indication for
use | as an aid in the diagnosis of
autoimmune thyroid diseases | same |
| Sample type | human serum and plasma | same |
| Dilution
performance | Autoantibodies are heterogenous and
this may lead to non-linear dilution
phenomena for certain individual
samples. | same |
| Traceability /
Standardization | WHO 66/387 | same |
| Test Principle | Competitive chemiluminescence | same |
2
510(k) Summary - COBAS Elecsys® anti-TPO, continued
| Topic | Elecsys® Anti-TPO
(K000155) | COBAS Elecsys® Anti-TPO
(Modified Device) |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Measuring
range | 5 - 600 IU/ml | Same |
| Reagent
Stability | Unopened:
- at 2-8°C up to the expiration date.
Opened: - at 2-8°C up to six weeks.
- on E170 / 2010: two weeks
- on 1010: one weeks store
alternately in refrigerator and on
analyzer - at ambient temperature 20-
25 °C; up to 20 hours in total). | Same |
| Limitations | No interference from;
Bilirubin up to 66 mg/dl | Same |
| Limitations | Hemolysis up to 1.5 g/dl | Same |
| Limitations | Lipemia up to 2100 mg/dl | Same |
| Limitations | Biotin up to 60 ng/ml | Biotin up to 10 ng/ml |
| Limitations | Rheumatoid factors up to 1500 U/ml | Same |
3
Public Health Service
Image /page/3/Picture/2 description: The image shows a logo for the Department of Health & Human Services (USA). The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the caduceus symbol.
Roche Diagnostics Corp. c/o Ms Kay A Taylor Regulatory Affairs Principal Centralized Diagnostics 9115 Hague Rd. Indianapolis, IN 46250
AUG 4 - 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Re: K051890
Trade/Device Name: Roche Diagnostics Cobas Elecsys® anti-TPO Test System Regulation Number: 21 CFR 866.5870 Regulation Name: Thyroid antibody Immunological Test System Regulatory Class: Class II Product Code: JZO Dated: July 11, 2005 Received: July 12, 2005
Dear Ms. Taylor:
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.
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 legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
4
Page 2 -
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 (240) 276-0484. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
bert Beckerh
Robert L. Becker, Jr., MD, PJ Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K051890
Device Name: cobas Elecsys Anti-TPO
Indications For Use:
The Elecsys Anti-TPO immunoassay is for the in vitro quantitative determination of antibodies to thyroid peroxidase in human serum and plasma. The anti-TPO determination is used as an aid in the diagnosis 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 XXXXX (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)
Maria M Clan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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510(k) K051890