(41 days)
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No
The device description details a standard enzyme immunoassay (ELISA) method based on chemical reactions and optical density measurements to determine TSH concentration. There is no mention of AI or ML algorithms being used for data analysis, interpretation, or any other function of the device. The performance studies rely on traditional statistical methods like linear regression and correlation coefficients.
No.
The device is an in vitro diagnostic (IVD) test that quantitatively determines TSH concentration in human serum. It is used to aid in the diagnosis of thyroid or pituitary disorders by measuring TSH, not to treat them.
Yes
Explanation: The device is used for the "diagnosis of thyroid or pituitary disorders" by quantitatively determining TSH concentration.
No
The device description clearly outlines a physical enzyme immunoassay (ELISA) kit with reagents and a microplate, indicating it is a hardware-based diagnostic test, 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 thyrotropin (TSH) concentration in human serum by a microplate enzymeimmunoassay." This involves testing a biological sample (human serum) outside of the body to obtain diagnostic information.
- Device Description: The description details a "microplate enzymeimmunoassay (IEMA) kit" for determining TSH in human serum. This is a laboratory-based test kit designed for in vitro use.
- Classification Name: The device classification name is "thyroid-stimulating hormone test system," and the product code JLW is associated with in vitro diagnostic devices.
- Performance Studies: The performance studies involve testing human serum specimens and comparing the results to a reference method (ICMA), which is another in vitro diagnostic technique.
All of these points clearly indicate that this device is designed to be used in vitro (outside the living organism) for diagnostic purposes.
N/A
Intended Use / Indications for Use
The quantitative determination of thyrotropin (TSH) concentration in human serum by a microplate enzymeimmunoassay.Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
Product codes
JLW
Device Description
The Monobind ELISA method is based on two-site immunoassay (sandwich) technology utilizing the streptavidin-biotin reaction to effect separation. Upon mixing monoclonal biotinylated anti-TSH antibody, the enzyme-labeled anti-TSH antibody and a serum containing the native antigen (TSH), reaction results between the native antigen (TSH) and the antibodies, without competition or steric hindrance, to form a soluble sandwich complex. Simultaneously, the complex is deposited to the well through the high affinity reaction of streptavidin and biotinylated antibody. After incubation is complete, decantation or aspiration separates the bound fraction. The enzyme activity on the well is directly proportional to the native antigen (TSH) concentration. By utilizing several different serum references of known antigen values, a dose response curve can be generated from which the antigen concentration 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 170 specimens from hypothyroid, euthyroid and hyperthyrold populations. The mean values for reference method (ICMA) and this method (microplate IEMA) are 4.21 ulU/mi and 4.54 µlU/mi respectively. The equation to a straight line (y= 0.47+ 0.968) and correlation coefficient (0.995) indicates good method agreement.
In addition recovery data demonstrated an average recovery of 98.1% when exogenous added thyrotropin was introduced into human serum specimens. Similarly, linearity studies showed an average 99.2% when specimens were diluted and compared to the dose response curve.
Key Metrics
correlation coefficient (0.995)
average recovery of 98.1%
average 99.2% (linearity)
Predicate Device(s)
Ciba Corning ACS 180
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1690 Thyroid stimulating hormone test system.
(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.
0
JUN 24 1997
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The characters appear to be a mix of letters and numbers. The string reads 'K971780'. The characters are written in black ink on a white background. A horizontal line is present below the string of characters.
Image /page/0/Picture/2 description: The image shows the logo for Monobind, Inc. The logo features a stylized, interconnected "MB" design in bold, black lines. Below the symbol, the words "MONOBIND, INC." are printed in a simple, sans-serif font, also in black.
Mav. 10. 97
510(k) Summarv
Dear Sir:
Monobind Inc., registration number 2020726, plans to introduce into commercial distribution an enzymeimmunoassay (IEMA) kit for the determination of thyrotropin (TSH) In human serum.
The proprietary name is Thyrotropin (TSH) ELISA and the usual name is TSH IEMA. This device classification name is - thyroid-stimulating hormone test system - product code JLW (per 21 CRF section 862.1690).
This device is substantially equivalent to the Ciba Corning ACS 180 chemiluminescence (ICMA) test, which predicates the new device.
The contact individual for this submission is Dr. Frederick R. Jerome.
The Monobind ELISA method is based on two-site immunoassay (sandwich) technology utilizing the streptavidin-biotin reaction to effect separation. Upon mixing monoclonal biotinylated anti-TSH antibody, the enzyme-labeled anti-TSH antibody and a serum containing the native antigen (TSH), reaction results between the native antigen (TSH) and the antibodies, without competition or steric hindrance, to form a soluble sandwich complex. Simultaneously, the complex is deposited to the well through the high affinity reaction of streptavidin and biotinylated antibody. After incubation is complete, decantation or aspiration separates the bound fraction. The enzyme activity on the well is directly proportional to the native antigen (TSH) concentration. By utilizing several different serum references of known antigen values, a dose response curve can be generated from which the antigen concentration of an unknown can be ascertained.
The intended use of the device: The quantitative determination of therotropin (TSH) concentration in human serum by a microplate enzymelmmunoassay.
The technological characteristics of the new device compared to the predicate device are very similar. This includes the use of two-site immunoassay (sandwich) technology using monoclonal and polyclonal antibodies, and human serum prepared calibrators (standardized against the same international reference material). The main difference resides in the use of an enzyme tracer compared to chemiluminescence as well as magnetic particles versus streptavidin coated polystvrene wells.
Substantial equivalency was based on clinical comparison (linear regression), using 170 specimens from hypothyroid, euthyroid and hyperthyrold populations. The mean values for reference method (ICMA) and this method (microplate IEMA) are 4.21 ulU/mi and 4.54 µlU/mi respectively. The equation to a straight line (y= 0.47+ 0.968) and correlation coefficient (0.995) indicates good method agreement.
In addition recovery data demonstrated an average recovery of 98.1% when exogenous added thyrotropin was introduced into human serum specimens. Similarly, linearity studies showed an average 99.2% 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
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
JUN 24 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Frederick R. Jerome Monobind, Inc. 729 West 16th Street ~ Costa Mesa, California 92627
Re : K971780 Thyrotropin (TSH) ELISA Regulatory Class: II Product Code: JLW Dated: May 13, 1997 Received: May 14, 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 Requlations, Title 21, Parts 800 to 895. ಗ 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 Please note: this response to your the Federal Register. 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.
Image /page/1/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The image is in black and white.
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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/dsmamain.html".
Sincerely yours,
Steven Gutman
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): K971780
Device Name: Thyrotropin (TSH) Microplate EIA
The quantitative determination of thyrotropin (TSH) concentration in human serum by a microplate enzymeimmunoassay.Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
(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 | K971780 |
| Prescription Use | ✓ | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Folmat 1-2-96) |