(299 days)
Not Found
No
The summary describes a bioassay for detecting antibodies and mentions changes to the number of wells used. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
This device is an in vitro diagnostic assay used for qualitative detection of autoantibodies to aid in the diagnosis of Graves' disease, rather than providing direct therapy or treatment.
Yes
The device is described as an "aid in the differential diagnosis of patients with Graves' disease (GD)," which clearly indicates a diagnostic purpose.
No
The device description clearly indicates a "BioAssay," which is a laboratory test involving biological materials and likely requires physical components (reagents, plates, etc.) for the assay itself, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection in serum of thyroid stimulating autoantibodies...". This involves testing a biological sample (serum) outside of the body to gain information about a patient's health status.
- Device Description: While the description focuses on changes to the testing procedure (reducing the number of wells), it describes a laboratory-based assay used to analyze samples.
- Predicate Device: The mention of a predicate device (K083391 Thyretain TM TSI Reporter BioAssay) which is also an IVD further confirms the nature of this device.
The core function of the device is to perform a test on a biological sample in vitro (outside the living organism) to aid in diagnosis. This is the defining characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Thyretain ™ TSI Reporter BioAssay is intended for the qualitative detection in serum of thyroid stimulating autoantibodies to the thyroid stimulating hormone (TSH) receptors (TSHRs) on the thyroid. The detection of these stimulating autoantibodies, in conjunction with other clinical and laboratory findings, may be useful as an aid in the differential diagnosis of patients with Graves' disease (GD).
Product codes
JZO
Device Description
The number of wells tested per Positive, Reference and Negative control has been reduced from three to two for each. The number of wells tested per patient specimen has been reduced from three to two.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thyroid
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
Not Found
Key Metrics
Not Found
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
Special 510(k): Device Modification Thyretain TM TSI Reporter BioAssay
Image /page/0/Picture/2 description: The image is a logo for Diagnostic Hybrids. The logo features the company name in bold, uppercase letters, with the word "DIAGNOSTIC" stacked above "HYBRIDS". Below the company name is the tagline "Integrating Science and Humanity" in a smaller, italicized font. To the right of the text is a stylized graphic that resembles a DNA strand intertwined with a human figure.
DATE OF PREPARATION OF 510(k) SUMMARY
July 15, 2009
APPLICANT
DIAGNOSTIC HYBRIDS, INC. 1055 East State Street Suite 100 Athens, OHIO 45701
MAY 1 8 2010
CONTACT INFORMATION
Ronald H. Lollar Senior Director, Product Realization, Management, and Marketing E-mail: lollar@dhiusa.com Telephone: 740-589-3300 Desk Extension: 740-589-3373 FAX: 740-593-8437
DEVICE NAME
Trade name: Thyretain TM TSI Reporter BioAssay Common name: TSI Reporter Classification name: System, Test, Thyroid Autoantibody Product Code: JZO Regulation: 21 CFR § 866.5870, Thyroid Autoantibody Immunological Test
LEGALLY MARKETED DEVICE
Thyretain TM TSI Reporter BioAssay (TSI Reporter), K083391
DESCRIPTION of DEVICE MODIFICATION
The number of wells tested per Positive, Reference and Negative control has been reduced from three to two for each. The number of wells tested per patient specimen has been reduced from three to two.
1
INTENDED USE
The Thyretain ™ TSI Reporter BioAssay is intended for the qualitative detection in serum of thyroid stimulating autoantibodies to the thyroid stimulating hormone (TSH) receptors (TSHRs) on the thyroid. The detection of these stimulating autoantibodies, in conjunction with other clinical and laboratory findings, may be useful as an aid in the differential diagnosis of patients with Graves' disease (GD).
ASSESSMENT OF NON-CLINICAL PERFORMANCE DATA FOR EQUIVALENCE
Not Applicable .
ASSESSMENT OF NON-CLINICAL PERFORMANCE DATA FOR EQUIVALENCE
The risk analysis method used to assess the impact of the modification was a Failure Modes and Effects Analysis (FMEA). Based on the analysis of the study site data (see Attachment 2) the modification poses little risk.
BIOCOMPATABILITY
Not applicable
STERILIZATION
Not applicable
2
Image /page/2/Picture/0 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 human figure or a caduceus, with three curved lines representing the body and a wavy line at the bottom representing the base.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Diagnostic Hybrids, Inc c/o Mr. Ronald H. Lollar Senior Director, Product Realization, Management and Marketing 1055 East State Street, Suite 100 Athens, Ohio 45701
MAY 1 8 2010
Re: K092229
| Trade/Device Name: | Thyretain ™ TSI Reporter BioAssay |
|---|---|
| Regulation Number: | 21 CFR §866.5870 |
| Regulation Name: | Thyroid autoantibody immunological test system |
| Regulatory Class: | Class II |
| Product Code: | JZO |
| Dated: | May 14, 2010 |
| Received: | May 17, 2010 |
Dear Mr. Lollar:
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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice
3
Page 2 - Mr. Ronald H. Lollar
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
iaj m Chen
Maria M. Chan, Ph.D Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): K092229
Device Name: Thyretain TM TSI Reporter BioAssay
Indication For Use:
The Thyretain ™ TSI Reporter BioAssay is intended for the qualitative detection in serum of thyroid stimulating autoantibodies to the thyroid stimulating hormone (TSH) receptors (TSHRs) on the thyroid. The detection of these stimulating autoantibodies, in conjunction with other clinical and laboratory findings, may be useful as an aid in the . differential diagnosis of patients with Graves' disease (GD).
Prescription Use ั้น (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Reena Philip
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K092229