(85 days)
DYNOtest anti-TPOn is a competitive radioimmunoassay for the quantitative determination of autoantibodies to thyroid peroxidase (TPO) in human serum using the coated tube technique. The DYNOtest anti-TPO, kit is used as an aid in the diagnosis of Hashimoto's thyroiditis and Graves' disease, autoimmune diseases affecting the thyroid gland.
DYNOtest anti-TPOn is a competitive radioimmunoassay intended for the quantitative determination of autoantibodies against thyroid peroxidase in human sera using a coated tube technique. Monoclonal antibodies against thyroid peroxidase bound to the solid phase compete with autoimmune anti-thyroid peroxidase antibodies in the sample for indirectly 12-1 labeled thyroid peroxidase. Following incubation, unreacted indirectly labeled thyroid peroxidase and unreacted 1251 labeled antibody against TPO is washed from the tube and radioactivity bound to the tube is counted. The measured radioactivity is inversely proportional to the quantity of anti-thyroid peroxidase antibody in the sample.
Here's an analysis of the provided text regarding the DYNOtest® anti-TPOn device, focusing on acceptance criteria and the supporting study:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Overall agreement with predicate device (Orgentec Anti-TPO ELISA) | 81.8% |
Note: The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit quantifiable acceptance criteria for novel performance metrics. The 81.8% agreement is presented as sufficient to demonstrate substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 77 serum samples
- Data Provenance: The document does not explicitly state the country of origin. It indicates the samples were "from patients with Graves' disease, Hashimoto's thyroiditis and non-autoimmune thyroid disease," implying they were clinical samples, likely retrospective given the nature of a 510(k) submission for an already developed product. The study is a "clinical comparison."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The "ground truth" for the test set is established by comparing the DYNOtest anti-TPOn results to those of the predicate device, the Orgentec Anti-TPO ELISA. The performance of the predicate device itself is the reference. There's no mention of independent expert review of the 77 samples to establish a separate ground truth.
4. Adjudication Method for the Test Set
This information is not applicable/provided as there's no mention of individual expert assessment and subsequent adjudication. The comparison is directly between the new device and the predicate device's results. The 2x2 table shows the direct agreement and disagreement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) assay; therefore, human interpretation/reading of the assay results is not the primary focus in the same way it would be for an imaging AI device. The comparison is between two automated assay results.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The "clinical comparison" directly compares the results of the DYNOtest anti-TPOn assay (the algorithm/device) to the results of the predicate Orgentec Anti-TPO ELISA. There is no human intervention or "human-in-the-loop" component in interpreting the quantitative results of either assay within this comparison.
7. The Type of Ground Truth Used
The "ground truth" for the comparison study is the results of the legally marketed predicate device, Orgentec Anti-TPO ELISA. The study evaluated whether the DYNOtest anti-TPOn agreed sufficiently with the established predicate device, which is a common approach for 510(k) submissions seeking substantial equivalence for IVD devices.
8. The Sample Size for the Training Set
This information is not provided and is generally not relevant for 510(k) submissions of traditional IVD assays like radioimmunoassays, as they are not "trained" in the typical machine learning sense. The device is a chemical/biological assay run on samples.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/provided for the reasons mentioned above. There is no "training set" or "ground truth" establishment in the context of machine learning training for this type of device.
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SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness is being submitted in accordance with the requirements of The Safe Medical Devices Act of 1990 (SMDA 1990) and 21 CFR 807.92.
I. GENERAL INFORMATION
| Date of Summary Preparation: | October 15, 1999 | |
|---|---|---|
| Distributor: | BRAHMS Diagnostica, LLC29 South Peachtree StreetNorcross, Georgia 30092 | |
| Manufacturer: | BRAHMS Diagnostica GmbHKomturstrasse 19-2012099 Berlin, Germany | |
| Contact Person: | H. Lee HerronPartnerBRAHMS Diagnostica, LLC29 South Peachtree StreetNorcross, Georgia 30092Tel: 770-449-7738Fax: 770-449-7739 | |
| Device Name: | DYNOtest® anti-TPOn | |
| Common or Usual Name: | Radioimmunoassay kit for the determination ofanti-thyroid peroxidase antibodies | |
| Classification:Name:ClassCFR: | Thyroid autoantibody immunological test systemClass II21 CFR 866.5870 | |
| Substantial Equivalence To: | Orgentec Anti-TPO ELISA |
II. INTENDED USE
. .
DYNOtest anti-TPOn is a competitive radioimmunoassay for the quantitative determination of autoantibodies to thyroid peroxidase (TPO) in human serum using the coated tube technique. The DYNOtest anti-TPO, kit is used as an aid in the diagnosis of Hashimoto's thyroiditis and Graves' disease, autoimmune diseases affecting the thyroid gland.
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III. DEVICE DESCRIPTION
DYNOtest anti-TPOn is a competitive radioimmunoassay intended for the quantitative determination of autoantibodies against thyroid peroxidase in human sera using a coated tube technique. Monoclonal antibodies against thyroid peroxidase bound to the solid phase compete with autoimmune anti-thyroid peroxidase antibodies in the sample for indirectly 12-1 labeled thyroid peroxidase. Following incubation, unreacted indirectly labeled thyroid peroxidase and unreacted 1251 labeled antibody against TPO is washed from the tube and radioactivity bound to the tube is counted. The measured radioactivity is inversely proportional to the quantity of anti-thyroid peroxidase antibody in the sample.
IV.COMPARISON TO PREDICATE DEVICE
The DYNOtest® anti-TPOn immunoassay kit is similar to the Orgentec Anti-TPO ELISA (K952129) in the indications for use, performance characteristics and results. The DYNOtest anti-TPOn test differs from the Orgentec Anti-TPO ELISA in assay format, solid phase and signal. In the DYNOtest anti-TPOn assay, monoclonal antibodies against thyroid peroxidase bound to the coated tube compete for radioactively labeled thyroid peroxidase with anti-thyroid peroxidase antibodies in the patient samples. The Orgentec Anti-TPO assay uses purified human thyroid peroxidase adhered to the microplate solid phase to capture antithyroid peroxidase antibodies in patient samples. Detection of the anti-TPO antibodies in the Orgentec assay is accomplished by incubation with horseradish peroxidase labeled anti-human IgG antibody followed by incubation with enzyme substrate and determination of optical density at 450 nm.
Substantial equivalence to the Orgentec Anti-TPO ELISA kit cleared under K952129 is based on a clinical comparison using 77 serum samples from patients with Graves' disease, Hashimoto's thyroiditis and non-autoimmune thyroid disease. Overall agreement based on a 2 X 2 agreement table was 63/77 = 81.8%.
| Orgentec Anti-TPO ELISA | |||
|---|---|---|---|
| DYNOtestAnti-TPO | Positive | Negative | |
| Positive | 58 | 7 | |
| Negative | 7 | 5 | |
| % Agreement = 81.8% |
% Agreement = 81.8%
This correlation study demonstrates that the DYNOtest anti-TPO, assay is substantially equivalent to the legally marketed predicate device, Orgentec Anti-TPO ELISA assay.
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NOV 1 2 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. H. Lee Herron Partner, BRAHMS, LLC BRAHMS Diagnostica, LLC 29 South Peachtree Street Norcross. Georgia 30092
Re: K992791 Trade Name: DYNOtest® anti-TPO, Regulatory Class: II Product Code: JZO Dated: August 18, 1999 Received: August 19, 1999
Dear Mr. Herron:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 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): K992791 Device Name: DYNOtest anti-TPOn
Indications For Use:
DYNOtest anti-TPO, is a competitive radioimmunoassay for the quantitative determination of autoantibodies to thyroid peroxidase (TPO) in human serum using the coated tube technique. The DYNOtest anti-TPO, kit is used as an aid in the diagnosis of Hashimoto's thyroiditis and Graves' disease, autoimmune diseases affecting the thyroid gland.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number KGG2791
Prescription Use ✓
(Per 21 CFR 801.109)
OR
Over-The-Counter Use __
§ 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).