(85 days)
No
The description details a radioimmunoassay based on competitive binding and radioactivity measurement, with no mention of AI or ML terms or functionalities.
No
This device is a diagnostic test kit used to measure antibodies for identifying certain thyroid diseases, not for treating them.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the kit "is used as an aid in the diagnosis of Hashimoto's thyroiditis and Graves' disease."
No
The device description clearly outlines a competitive radioimmunoassay kit involving physical components like coated tubes, labeled thyroid peroxidase, and a washing step, followed by radioactivity counting. This is a laboratory assay kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of autoantibodies to thyroid peroxidase (TPO) in human serum." This involves testing a sample taken from the human body (serum) in vitro (outside the body).
- Device Description: The description details a "competitive radioimmunoassay" using a "coated tube technique" to measure substances in "human sera." This further confirms the in vitro nature of the testing.
- Aid in Diagnosis: The intended use also states it's used as an "aid in the diagnosis" of specific diseases. This is a common purpose of IVD devices.
The information provided clearly indicates that this device is designed to perform tests on biological samples outside of the body to provide information for diagnostic purposes, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
JZO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thyroid gland
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
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%.
Key Metrics
Overall Agreement = 81.8%
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
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, LLC | |
| 29 South Peachtree Street | ||
| Norcross, Georgia 30092 | ||
| Manufacturer: | BRAHMS Diagnostica GmbH | |
| Komturstrasse 19-20 | ||
| 12099 Berlin, Germany | ||
| Contact Person: | H. Lee Herron | |
| Partner | ||
| BRAHMS Diagnostica, LLC | ||
| 29 South Peachtree Street | ||
| Norcross, Georgia 30092 | ||
| Tel: 770-449-7738 | ||
| Fax: 770-449-7739 | ||
| Device Name: | DYNOtest® anti-TPOn | |
| Common or Usual Name: | Radioimmunoassay kit for the determination of | |
| anti-thyroid peroxidase antibodies | ||
| Classification: | ||
| Name: | ||
| Class | ||
| CFR: | Thyroid autoantibody immunological test system | |
| Class II | ||
| 21 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.
1
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 | |||
|---|---|---|---|
| DYNOtest | |||
| Anti-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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus, featuring three parallel lines that curve and merge into a single form at the bottom.
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.
3
Page 2
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
4
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 __