(299 days)
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).
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.
The provided submission (K092229) is a special 510(k) for a device modification; therefore, it primarily focuses on demonstrating that the device, post-modification, remains substantially equivalent to its predicate device. This type of submission usually doesn't include new, large-scale clinical studies with specific acceptance criteria as would be found in a De Novo or PMAs. Instead, it relies on bridging data to show the modification doesn't negatively impact performance.
Here's an analysis based on the provided text:
Device: Thyretain™ TSI Reporter BioAssay (Modified)
Predicate Device: Thyretain™ TSI Reporter BioAssay (K083391)
Modification: Reduction of the number of wells tested per Positive, Reference, and Negative control from three to two. Reduction of wells tested per patient specimen from three to two.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal acceptance criteria in a quantitative manner (e.g., "sensitivity must be >90%"). Instead, the performance assessment aims to demonstrate that the modified device remains equivalent to the predicate, particularly in its non-clinical performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| No significant negative impact on device performance due to modification. | "Based on the analysis of the study site data (see Attachment 2) the modification poses little risk." |
| Maintain the intended use and diagnostic accuracy. | Intent to maintain the same intended use as the predicate device. The FMEA indicated little risk from the modification. |
Note: "Attachment 2" which would contain the detailed study site data is not provided in the input, so specific quantitative performance metrics like sensitivity, specificity, or agreement with the predicate are not available in this summary. The assessment focuses on risk analysis.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "study site data" in "Attachment 2". However, the details of this data, including sample size, provenance (country of origin), and whether it was retrospective or prospective, are not provided in the given text extract.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the given text extract. Given this is a modification to an in vitro diagnostic (IVD) device, the ground truth would likely refer to established diagnostic methods or clinical outcomes, rather than expert interpretation of images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the given text extract. It is unlikely to be relevant for this type of IVD modification, which assesses analytical performance rather than interpretation by human readers.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. A MRMC comparative effectiveness study was not done. This is an in vitro diagnostic device (a bioassay) for detecting autoantibodies, not an imaging device that requires human interpretation or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable in the context of this device. The Thyretain™ TSI Reporter BioAssay is a laboratory assay for detecting antibodies, not an algorithm. The "performance" refers to the analytical performance of the assay itself. The submission is not about an algorithm, but a modification to the assay's procedure (number of wells).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The submission is for an immunoassay. The ground truth for such an assay would typically be established by:
- Reference methods: Comparison to established, clinically validated assays for the same analyte.
- Clinical diagnosis: Correlation with the clinical diagnosis of Graves' disease (GD), which would involve a combination of clinical symptoms, other laboratory findings, and potentially outcomes data over time.
- Pathology: Less likely to be the primary ground truth for an antibody assay, but could be part of the broader clinical picture for Graves' disease.
The provided text does not explicitly state the type of ground truth used for the "study site data" referenced.
8. The sample size for the training set
This information is not provided in the given text extract. For an IVD assay modification, there isn't typically a "training set" in the machine learning sense. Any data used to validate the modified procedure would be considered a "test set" or verification/validation data.
9. How the ground truth for the training set was established
As there is no "training set" in the context of this IVD device, this question is not applicable. Any ground truth for validation samples would be established by methods similar to those described in point 7.
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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.
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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
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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
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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
§ 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).