(104 days)
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No
The description details a standard enzyme immunoassay (EIA) for detecting antibodies. There is no mention of AI, ML, or any computational analysis beyond standard quantitative measurement and comparison to a predicate device.
No.
The device is an in vitro diagnostic test used to aid in the diagnosis of thyroid diseases by detecting antibodies, not to treat or cure them.
Yes
The "Intended Use / Indications for Use" section states that the device can "aid in the diagnosis of thyroid diseases."
No
The device description clearly states it is a solid-phase enzyme immunoassay (EIA) performed in microwells, indicating it is a physical test kit with reagents and hardware components, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states "For the quantitative detection of IqG antibodies to thyroid peroxidase in human serum by enzyme immunoassay." and the last sentence clearly says "For in vitro diagnostic use only." This directly indicates its purpose is to diagnose conditions using samples taken from the human body.
- Device Description: It describes a "solid-phase enzyme immunoassay (EIA), which is performed in microwells... to detect IgG antibodies... in human serum." This is a typical description of an in vitro diagnostic test.
- Performance Studies: The performance studies involve testing "serum specimens," which are samples taken from the human body.
- Predicate Device(s): The predicate device listed is another "Anti-Thyroid Peroxidase" test, which is also an IVD.
All of these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Anti-Thyroid Peroxidase test is intended for the quantative detection of human IgG antibodies to thyroid peroxidase antigen, in human serum by enzyme immunoassay. The presence of anti-thyroid peroxidase antibodies can be used with other serological tests and clinical findings to aid diagnosing individuals with Autoimmune Thyroditis and Grave's Disease. For In Vitro Diagnostic Use Only.
- For the quantitative detection of IqG antibodies to thyroid peroxidase in human serum by enzyme immunoassay.
- The SeraQuest Anti-thyroid peroxidase test can be used with other serological tests and clinical findings, to aid in the diagnosis of thyroid diseases such as Autoimmune Thyroiditis and Graves' disease.
- For in vitro diagnostic use only.
Product codes
JZO
Device Description
The SeraQuest Anti-Thyroid Peroxidase test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minutes incubations. It has been developed to detect IgG antibodies which are directed against Thyroid Peroxidase, in human serum.
The Calibrators in the SeraQuest Anti-Thyroid Peroxidase test kit have been assigned values based on the NIBSC standard. Test results are reported as international units per milliliter (IU/mL).
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
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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
141 serum specimens were tested at Quest International, Inc., concurrently by the SeraQuest Anti-Thyroid Peroxidase test, and the Varelisa TPO Antibodies test (Pharmacia & Upjohn). The assays were performed and interpreted according to the instructions in the manufacturer's package inserts.
Summary of Performance Studies
The qualitative agreement between the SeraQuest and the Pharmacia tests is shown in Table 1.
Of the 141 specimens tested, 22 were positive, 107 were negative and 1 was equivocal in both the SeraQuest and Varclisa tests (please see Table C-3). Of the 11 specimens remaining, 1 specimen which was negative by the Varelisa test, was positive by the SeraQuest test; 1 specimen which was negative in the Serclivest test, was equivocal by the Varelisa test; 7 which were equivocal in the SeraQuest test, 2 vere positive and 5 negative in the Varelisa test; 2 which were equivocal in the Varelisa test were positive in the SeraQuest test.
Excluding the equiv cal results, the sensitivity of the SeraQuest Anti-Thyroid Peroxidase (TPO) test relative to the Varaint test was 100%, or 99.9% to 100% (95% C.I.); the specificity was 99.1%, or 97.7% to 100% (95% C.I.); respectively. The overall agreement was 99.2%, or 97.3% to 100% (95% C.I.) (please see Talla C-3).
The specimen that gave a discordant result was tested by a second legally marketed device, the Scimedix Anti-Thyroid Peroxidase Test, Scimedix Corp., Denville, New Jersey. The sample gave a positive result with the Scimedix test.
Key Metrics
Relative Sensitivity: 100% (95% C.I. 99.9-100)
Relative Specificity: 99.1% (95% C.I. 97.7-100)
Overall Agreement: 99.2% (95% C.I. 97.3-100)
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
KO23593 510(k) SUMMARY
| Applicant: | Quest International, Inc.
1938 N.E. 148th Terrace
North Miami, FL 33181 | FEB 06 2003 |
|------------------------|---------------------------------------------------------------------------------------------------------|-------------|
| Registration No. | 1061839 | |
| Contact Person: | Robert A. Cort, V.P., Quality Assurance | |
| Telephone: | (305) 948-8788 | |
| Telefax: | (305) 948-4876 | |
| Manufacturing Site: | Same as above | |
| Device: | SeraQuest® Anti-Thyroid Peroxidase | |
| Device Name: | Anti-Thyroid Peroxidase, Multiple autoantibodies immunological tes
system (21CFR § 866.5660)
5870 | |
| Device Classification: | Class II (Performance Standards) | |
Description:
The SeraQuest Anti-Thyroid Peroxidase test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minutes incubations. It has been developed to detect IgG antibodies which are directed against Thyroid Peroxidase, in human serum.
The Calibrators in the SeraQuest Anti-Thyroid Peroxidase test kit have been assigned values based on the NIBSC standard. Test results are reported as international units per milliliter (IU/mL).
Principle:
Diluted samples are incubated in wells coated with thyroid peroxidase antigen. Antibodies directed against this antigen (if present) are immobilized in the wells. Residual sample is eliminated by washing and draining, and conjugate (enzyme-labeled antibodies to human IgG) is added and incubated. If IgG antibodies to thyroglobulin antigen are present, the conjugate will be immobilized in the wells. Residual coniugate is eliminated by washing, and the enzyme substrate is added and incubated. In the presence of the enzyme, the substrate is converted to a yellow end-product which is read photometrically at 405 nm.
Intended Use:
iended Use: The Anti-Thyroid Peroxidase test is intended for the quantative detection of human IgG antibodies to thyroid peroxidase antigen, in human serum by enzyme immunoassay. The presence of anti-thyroid peroxidase antibodies can be used with other serological tests and clinical findings to aid
1
diagnosing individuals with Autoimmune Thyroditis and Grave's Disease. For In Vitro Diagnostic Use Only.
Predicate Device:
The SeraQuest Anti-Thyroid Peroxidase test is substantially equivalent in intended use and performance, to the Pharmcia Varelisa TPO Antibodies, Freiburg, Germany.
Summary of Technological Characteristics:
| Characteristic | SeraQuest
Anti-Thyroid Peroxidase
Test | Pharmacia
Varelisa
TPO Antibodies Test |
|--------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Description: | Enzyme Immunoassay | Enzyme Immunoassay |
| Intended Use: | The detection of IgG
antibodies against
thyroid peroxidase
in human serum. | The detection of IgG
antibodies against
thyroid peroxidase
in human serum. |
| Solid Phase: | Polystyrene Microwell | Polystyrene Microwell |
| Antigen: | Purified
thyroid peroxidase
(human thyroid) | Recombinant
thyroid peroxidase |
| Number of Incubation Periods: | Three | Three |
| Sample Dilution: | 1:51 | 1:101 |
| Sample Incubation
Duration: | 30 minutes | 30 minutes |
| Incubation Temperature: | Room temperature | Room temperature |
| Ezyme-labeled Conjugate: | | |
| Antibody | Goat anti-human IgG | Goat anti-human IgG |
| Enzyme | Alkaline phosphatase | Horse Radish Peroxidase |
| Conjugate Volume: | 100 μl | 100 μl |
| Conjugate Incubation
Duration: | 30 minutes | 30 minutes |
| Substrate: | p-Nitrophenyl
phosphate | TMB |
| Subtrate Volume: | 100 μl | 100 μl |
| Substrate Incubation
Duration: | 30 minutes | 10 minutes |
| Stop Reagent: | 0.5 M Trisodium
phosphate | 0.34 M
Sulfuric acid |
| Stop Reagent Volume: | 100 μl | 50 μl |
| Readout: | Spectrophotometric | Spectrophotometric |
| Wavelength:
Reference Wavelength: | 405 nm
620 nm | 450 nm |
| Normalization: | Standard Curve | Standard Curve |
| Reporting Unit: | IU / mL | IU / mL |
2
APPENDIX 3.
Summary of Clinical Testing:
Experimental Procedure
To challenge the cutoff values, 141 serum specimens were tested at Quest International, Inc., concurrently by the SeraQuest Anti-Thyroid Peroxidase test, and the Varelisa TPO Antibodies test (Pharmacia & Upjohn). The assays were performed and interpreted according to the instructions in the manufacturer's package inserts.
Results and Conclusion
The qualitative agreement between the SeraQuest and the Pharmacia tests is shown in Table 1.
Of the 141 specimens tested, 22 were positive, 107 were negative and 1 was equivocal in both the SeraQuest and Varclisa tests (please see Table C-3). Of the 11 specimens remaining, 1 specimen which was negative by the Varelisa test, was positive by the SeraQuest test; 1 specimen which was negative in the Serclivest test, was equivocal by the Varelisa test; 7 which were equivocal in the SeraQuest test, 2 vere positive and 5 negative in the Varelisa test; 2 which were equivocal in the Varelisa test were positive in the SeraQuest test.
Excluding the equiv cal results, the sensitivity of the SeraQuest Anti-Thyroid Peroxidase (TPO) test relative to the Varaint test was 100%, or 99.9% to 100% (95% C.I.); the specificity was 99.1%, or 97.7% to 100% (95% C.I.); respectively. The overall agreement was 99.2%, or 97.3% to 100% (95% C.I.) (please see Talla C-3).
3
ABLE 1.
RESULTS OF SeraQuest ANTI-THYROGLOBULIN ASSAYS AND PHARMACIA ANTI-THYROGLOBULIN ASSAYS ON 141 SERUM SPECIMENS.
| SeraQuest | ||||||
|---|---|---|---|---|---|---|
| PHARMACIA | POS | EQU | NEG | % | 95% C.I.** | |
| POS | 22 | 2 | 0 | Relative Sensitivity* | 100 | 99.9-100 |
| EQU | 2 | 1 | 1 | |||
| NEG | 1 | 5 | 107 | Relative Specificity* | 99.1 | 97.7-100 |
| Overall Agreement* | 99.2 | 97.3-100 |
- Excluding equivocal results.
** 95%Confidence Interval calculated by the normal method.
The specimen that gave a discordant result was tested by a second legally marketed device, the Scimedix Anti-Thyroid Peroxidase Test, Scimedix Corp., Denville, New Jersey. The sample gave a ാsitive result with the Scimedix test.
4
Image /page/4/Picture/1 description: The image shows a logo for the Department of Human Services USA. The logo consists of a circular border with the text "HUMAN SERVICES USA DEPARTMENT" arranged around it. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked one behind the other, with flowing lines suggesting movement or connection.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 0 6 2003
Mr. Robert A. Cort Vice President, Quality Assurance Quest International, Inc. 1938 N.E. 148th Terrace North Miami, FL 33181
Re: K023593
Trade/Device Name: SeraQuest Anti Thyroid Peroxidase (TPO) Regulation Number: 21 CFR 866.5870 Regulation Name: Thyroid Autoantibody Immunological Test System Regulatory Class: Class II Product Code: JZO Dated: December 23, 2002 Received: December 24, 2002
Dear Mr. Cort:
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. Iisting 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 –
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 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 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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181 Page No. . . - -
APPENDIX 6
Page
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: SeraQuest Anti-Thyroid Peroxidase (TPO)
Indications For Use:
- For the quantitative detection of IqG antibodies to thyroid peroxidase in human ﺎ . serum by enzyme immunoassay.
- The SeraQuest Anti-thyroid peroxidase test can be used with other serological 2. tests and clinical findings, to aid in the diagnosis of thyroid diseases such as Autoimmune Thyroiditis and Graves' disease.
-
- For in vitro diagnostic use only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A. Plewes for S. Bautista
Division of Clinical Labora 510/k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)