(157 days)
Not Found
No
The summary describes a standard immunoassay using electrochemiluminescence detection and a calibration curve, with no mention of AI or ML technologies.
No
The device is an in vitro diagnostic immunoassay that aids in the detection of autoimmune thyroid disease by quantifying antibodies to thyroglobulin; it does not provide therapy.
Yes
The intended use states that the device is for the "determination of antibodies to thyroglobulin in human serum and plasma" and is used as "an aid in the detection of autoimmune thyroid disease," indicating its role in diagnosis.
No
The device description clearly states it is an immunoassay using streptavidin microparticles and electrochemiluminescence detection, which are hardware components and chemical reagents, not software.
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 device analyzes "human serum and plasma," which are biological samples taken from the body but tested outside of it.
- Purpose: The determination of anti-Tg is used as an "aid in the detection of autoimmune thyroid disease," which is a diagnostic purpose.
- Device Description: The description details an "electrochemiluminescence immunoassay," which is a common type of assay used in IVD testing.
- Performance Studies: The document includes performance data like reproducibility and precision, which are standard for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a "Predicate Device" with a K number (K991094) indicates that this device is being compared to a previously cleared IVD device, a common process for regulatory submission of new IVDs.
All of these elements strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Anti-Tg determination is used as an aid in the detection of autoimmune thyroid diseases.
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 disease.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys® 1010 / 2010 and Modular Analytics E170 (Elecsys module) Immunoassay Analyzers.
Product codes (comma separated list FDA assigned to the subject device)
JZO
Device Description
The ELECSYS® Anti-Tg Assay 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)
Reproducibility was determined using Elecsys reagents, pooled human sera and commercial controls according to a modified protocol (EP5-A) of the NCCLS: five or six times daily for 10 days (n = 59 or 60); intra-assay precision on E170, n = 21.
Intra-assay precision (%CV) for Human Serum:
• 4.9% at 62.8 IU/ml
• 5.1% at 115 IU/ml
• 4.6% at 290 IU/ml
• 5.6% at 2894 IU/ml
Intra-assay precision (%CV) for Controls:
• 5.5% at 99.5 IU/ml
• 5.6% at 232 IU/ml
Total precision (%CV) for Human Serum:
• 8.7% at 62.8 IU/ml
• 7.2% at 115 IU/ml
• 5.9% at 290 IU/ml
• 6.3% at 2894 IU/ml
Total precision (%CV) for Controls:
• 7.2% at 99.5 IU/ml
• 6.7% at 232 IU/ml
Analytical sensitivity:
§ 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
*020672
510(k) Summary - ELECSYS® Anti-Tg on ELECSYS® Immunoassay Analyzers
| 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 Corporation |
| 9115 Hague Rd | |
| Indianapolis IN 46250 | |
| (317) 521-3831 | |
| Contact person: Sherri L. Coenen | |
| Date prepared: February 27, 2002 | |
| Device Name | Proprietary name: ELECSYS® Anti-Tg Assay |
| Common name: Antibodies to thyroglobulin (Anti-Tg) | |
| Classification name: Thyroid autoantibody immunological test system | |
| Device description | The ELECSYS® Anti-Tg Assay 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. |
1
| Intended use | Immunoassay for the in vitro quantitative determination of antibodies to thyroglobulin in human serum and plasma. |
|---|---|
| Indication for use | The Anti-Tg determination is used as an aid in the detection of autoimmune thyroid diseases. |
| Substantial equivalence | The ELECSYS Anti-Tg test is equivalent to other devices legally marketed in the United States. We claim equivalence to the DPC Immulite 2000 Anti-TG AB (K991094). |
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The following table compares the ELECSYS® Anti-Tg, with the Predicate Substantial equivalence -Devices. similarities
| Feature | New Device
ELECSYS Anti-Tg | Predicate Device
Immulite 2000 Anti-TG Ab |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Immunoassay for the in vitro
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
immunoassay analyzers. | For in vitro diagnostic use with
the Immulite 2000 analyzer –
for the quantitative
measurement of autoantibodies
to thyroglobulin (TG) in serum
EDTA and heparinized
plasma, as an aid in the clinical
diagnosis of thyroid diseases. |
| Sample type | Human serum
Human plasma treated with
sodium heparin, or K2/K3-
EDTA | human serum, EDTA, and
heparinized plasma |
| Assay
Protocol | competitive assay | immunometric assay |
| Detection
Protocol | electrochemiluminescence
immunoassay | chemiluminescence assay |
| Traceability | Calibrated against NIBSC
65/93 Standard | Calibrated against NIBSC
65/93 Standard |
3
Substantial equivalence differences
The following table compares the ELECSYS® Anti-Tg with the Predicate Device.
| Feature | New Device
ELECSYS Anti-Tg | Predicate Device
Immulite 2000 Anti-TG Ab |
|-----------------|-----------------------------------------------------------------------------|------------------------------------------------|
| Measuring range | 10 – 4000 IU/ml | 0 – 3000 IU/ml |
| Expected values | Up to 115 IU/ml (95th
percentile) | Nondetectable to 40 IU/ml
(95th percentile) |
| Instrument | ELECSYS® 2010, 1010,
and Modular Analytics E170
Immunoassay Analyzers | Immulite 2000 Analyzer |
Substantial equivalence performance characteristics
The performance characteristics of the ELECSYS Anti-Tg and the Predicate Device are compared in the table below.
Reproducibility was determined using Elecsys reagents, pooled human sera and commercial controls according to a modified protocol (EP5-A) of the NCCLS: five or six times daily for 10 days (n = 59 or 60); intra-assay precision on E170, n = 21. The following results were obtained:
| Feature | New Device
ELECSYS Anti-Tg | Predicate Device
Immulite 2000 Anti-TG Ab |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Intra-assay
precision (%CV) | Human Serum
• 4.9% at 62.8 IU/ml
• 5.1% at 115 IU/ml
• 4.6% at 290 IU/ml
• 5.6% at 2894 IU/ml
Controls
• 5.5% at 99.5 IU/ml
• 5.6% at 232 IU/ml | • 4.9% at 43 IU/ml
• 3.2% at 92 IU/ml
• 3.5% at 205 IU/ml
• 4.0% at 324 IU/ml
• 3.7% at 508 IU/ml
• 3.9% at 736 IU/ml |
| Total precision
(%CV) | Human Serum
• 8.7% at 62.8 IU/ml
• 7.2% at 115 IU/ml
• 5.9% at 290 IU/ml
• 6.3% at 2894 IU/ml
Controls
• 7.2% at 99.5 IU/ml
• 6.7% at 232 IU/ml | • 5.7% at 23 IU/ml
• 4.6% at 63 IU/ml
• 5.0% at 201 IU/ml
• 5.8% at 381 IU/ml
• 5.0% at 784 IU/ml
• 5.7% at 1644 IU/ml |
4
Substantial equivalence performance characteristics, continued
The performance characteristics of the ELECSYS anti-Tg and the Predicate Device are compared in the table below.
| Feature | New Device
ELECSYS Anti-Tg | Predicate Device
Immulite 2000 Anti-TG Ab |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Analytical
sensitivity | Trade/Device Name: ELECSYS® Anti-Tg Assay Regulation Number: 21 CFR § 866.5870 Regulation Name: Thyroid Autoantibody Immunological Test System Regulatory Class: II Product Code: JZO Dated: May 9, 2002 Received: May 13, 2002
Dear Ms. Coenen:
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 (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 Butman
: 上
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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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): N/A KO 20 6 7 2
Device Name: ELECSYS® Anti-Tg Test System
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 disease.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys® 1010 / 2010 and Modular Analytics E170 (Elecsys module) Immunoassay Analyzers.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use V V ---------------------------------------------------------------------------------------------------------------------------------------------------------OR Over-The-Counter Use (Per 21 CFR 801.109)
(Optional Format 1-2-
: 本
તેર)
JP Rubio for G. Attain
V
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K020672