(45 days)
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No
The device description and performance studies detail a standard ELISA assay based on chemical reactions and optical density measurements, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is used for the "quantitative determination of thyroglobulin autoantibodies" to "aid in the diagnosis of certain thyroid diseases", making it a diagnostic device rather than a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements of Tg autoantibodies may aid in the diagnosis of certain thyroid diseases such as Hashimoto, Graves, and nontoxic goiter." This direct link to aiding in disease diagnosis classifies it as a diagnostic device.
No
The device description clearly outlines a laboratory-based ELISA assay involving physical reagents, incubation steps, and measurement of enzyme activity, indicating it is a hardware-based diagnostic kit, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "The quantitative determination of thyroglobulin autoantibodies in human serum or plasma by a microplate enzymeimmunoassay." This clearly indicates the device is used to test human specimens (serum or plasma) in vitro (outside the body) to obtain diagnostic information (determining the presence and quantity of autoantibodies).
- Device Description: The description details a laboratory-based assay using ELISA technology to analyze components of a human sample. This is characteristic of an in vitro diagnostic device.
- Performance Studies: The performance studies describe testing biological specimens from human populations (normal and disease states) and comparing the results to a reference method. This is a standard practice for validating the performance of an IVD.
- Predicate Device: The mention of a "Predicate Device" which is another "anti-thyroglobulin ELISA test" further confirms that this device falls within the category of IVDs. Predicate devices are used in regulatory submissions for new IVDs to demonstrate substantial equivalence to existing legally marketed devices.
In summary, the device's purpose, methodology, and the context of its performance evaluation all point to it being an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The quantitative determination of thyroglobulin (Tg) autoantibodies in human serum or plasma by a microplate enzymeimmunoassay. Measurements of Tg autoantibodies may aid in the diagnosis of certain thyroid diseases such as Hashimoto, Graves, and nontoxic goiter.
Product codes
DDC
Device Description
Monobind Inc., registration number 2020726, plans to introduce into commercial distribution an ELISA kit for the determination of thyroglobulin autoantibodies in human serum or plasma.
The proprietary name is Anti-Thyroglobulin (Tg) Microplate ELISA and the usual name is Anti-Ta ELISA. This device classification name is - thyroid autoantibody immunological test system - product code DDC (per 21 CRF section 866.5870).
The Monobind method is based on ELISA technology utilizing the streptavidin-blotin reaction to effect separation. Upon mixing blotinylated thyroglobulin antigen, and a serum containing the autoantibody (anti-Tg), reaction results between the biotinylated thyroglobulin antigen and the antibodies to form an immune complex. Simultaneously, the complex is deposited to the well through the high affinity reaction of streptavidin, coated on the well, and biotinylated thyroglobulin antigen. After incubation is complete, decantation or aspiration separates the unbound components. The enzyme linked species specific antibody (anti-h-igG) is then added to the microwells. The anti-h-lgG enzyme conjugate that binds to the immobilized immune complex in a second incubation are separated from unreacted material by a wash step. The enzyme activity in this fraction Is directly proportional to the antibody concentration in the specimen. By utilizing several different serum references of known antibody activity, a reference curve can be generated from which the antibody activity of an unknown can be ascertained.
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
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Summary of Performance Studies
Substantial equivalency was based on clinical comparison (linear regression), using 82 biological specimens from normal and disease states populations. The disease states Included; Hashimoto's thyroiditis, Graves Disease, thyroid nodules as well as thyroid carcinoma. The mean values for reference method and this method are 419.2 IU/ml and 415.6 IU/ml respectively. The equation to a straight-line [ v= 9.79+0.969 (x) ] and correlation coefficient (0.995) Indicates good method agreement.
In addition, linearity studies showed an average 98.7% recovery when specimens were diluted and compared to the dose response curve.
Key Metrics
Correlation coefficient (0.995)
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).
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Image /page/0/Picture/0 description: The image shows the logo for MONOBIND, INC. The logo consists of a stylized letter "B" formed by two interconnected shapes. Below the logo, the text "MONOBIND, INC." is printed in a bold, sans-serif font. Underneath the company name, the date "May. 14, 97" is printed in a bold, italicized font.
K 921835
JUL - 3 1997
510(k) Summarv
Dear Sir:
Monobind Inc., registration number 2020726, plans to introduce into commercial distribution an ELISA kit for the determination of thyroglobulin autoantibodies in human serum or plasma.
The proprietary name is Anti-Thyroglobulin (Tg) Microplate ELISA and the usual name is Anti-Ta ELISA. This device classification name is - thyroid autoantibody immunological test system - product code DDC (per 21 CRF section 866.5870).
This device is substantially equivalent to the Biomerica anti-thyroglobulin ELISA test, which predicates the new device.
The contact Individual for this submission is Dr. Frederick R. Jerome.
The Monobind method is based on ELISA technology utilizing the streptavidin-blotin reaction to effect separation. Upon mixing blotinylated thyroglobulin antigen, and a serum containing the autoantibody (anti-Tg), reaction results between the biotinylated thyroglobulin antigen and the antibodies to form an immune complex. Simultaneously, the complex is deposited to the well through the high affinity reaction of streptavidin, coated on the well, and biotinylated thyroglobulin antigen. After incubation is complete, decantation or aspiration separates the unbound components. The enzyme linked species specific antibody (anti-h-igG) is then added to the microwells. The anti-h-lgG enzyme conjugate that binds to the immobilized immune complex in a second incubation are separated from unreacted material by a wash step. The enzyme activity in this fraction Is directly proportional to the antibody concentration in the specimen. By utilizing several different serum references of known antibody activity, a reference curve can be generated from which the antibody activity of an unknown can be ascertained.
The intended use of the device: The quantitative determination of thyroglobulin (Tg) autoantibodies in human serum or plasma by a microplate enzymeimmunoassay.
The technological characteristics of the new device compared to the predicate device are very similar. This includes ELISA technology with highly purified thyroglobulin antigen. and diluted human serum prepared calibrators (standardized against the same international reference material 1st IRP 65/93). A difference lles in the use of anti-hlgG -HRP (Monobind method) versus HRP-Protein A (Biomerica method) to expose the antibody activity on the solid phase. However, both reagents' function is to detect anti-h-IgG on the solid phase. The enzyme and substrate systems are the same.
Substantial equivalency was based on clinical comparison (linear regression), using 82 biological specimens from normal and disease states populations. The disease states Included; Hashimoto's thyroiditis, Graves Disease, thyroid nodules as well as thyroid carcinoma. The mean values for reference method and this method are 419.2 IU/ml and 415.6 IU/ml respectively. The equation to a straight-line [ v= 9.79+0.969 (x) ] and correlation coefficient (0.995) Indicates good method agreement.
In addition, linearity studies showed an average 98.7% recovery when specimens were diluted and compared to the dose response curve.
729 West 16" Street , Costa Mesa , CA (USA) 92627 Phone: (714) 642-4830 FAX: (714) 650-8459
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Image /page/1/Picture/0 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a human figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Frederick Jerome 729 West 16th Street, C-4 Costa Mesa, CA 92627
JUL - 3 1997
Re: K971835 Trade Name: Anti-thyroglobulin (Tg) Microplate ELISA Regulatory Class: II Product Code: DDC Dated: May 14, 1997 Received: May 19, 1997
Dear Dr. Jerome:
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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 promarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Preduct Radiation Control provisions, or other Federal Laws or Regulations.
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.
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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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Toutman
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): K971835
Device Name: Anti-thyroglobulin(Tg) Microplate ELISA
The quantitative determination of thyroglobulin autoantibodies in human serum or plasma by a microplate enzymeimmunoassay. Measurements of Tg autoantibodies may aid in the diagnosis of certain thyroid diseases such as Hashimoto, Graves, and nontoxic goiter.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Deborah Moore for
Dr. Peter Maxim
(Division Sign-00
Division of Clinical Laboratory Devices
510(k) Number K971835
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Folmat 1-2-96)