(33 days)
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No
The device description details a standard enzyme immunoassay (EIA) kit, which is a biochemical method for measuring substances. There is no mention of AI or ML in the device description, intended use, or performance studies. The performance studies focus on traditional analytical validation metrics like linear regression and recovery, not AI/ML specific metrics.
No.
The device is used for diagnosis and monitoring of thyroid diseases by measuring T3 levels, but it does not directly treat or prevent a disease.
Yes
The device is described as "quantitative determination of total triiodothyronine concentration... The results obtained are used in the diagnosis and treatment of thyroid diseases". This explicitly states its role in diagnosis.
No
The device description clearly outlines a physical kit with reagents, microplates, and a competition reaction process, indicating it is a hardware-based immunoassay 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 total triiodothyronine concentration in human serum or plasma... The results obtained are used in the diagnosis and treatment of thyroid diseases such as hyperthyoidism." This clearly indicates the device is used to examine specimens derived from the human body (serum or plasma) to provide information for diagnostic purposes.
- Device Description: The description details a laboratory test (enzyme immunoassay) performed on human specimens (serum or plasma) to measure a specific analyte (total triiodothyronine).
- Product Code: The product code CPD (per 21 CRF section 862.1710) is associated with "enzyme immunoassay, non-radiolabeled, total trilodothyronine," which falls under the category of clinical chemistry and toxicology devices, a common area for IVDs.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for the diagnosis, treatment, or prevention of disease.
N/A
Intended Use / Indications for Use
The quantitative determination of total triiodothyronine concentration in human serum or plasma by a microplate enzyme immunoassay.
Product codes
CPD
Device Description
Monobind microplate EIA utilizes anti-triiodothyronine antibody immobilized on the surface of plastic wells of a microtiterplate. Specimens, calibrators or controls are then added followed by the enzyme-T3 conjugate. A competition reaction results between the native triiodothyronine in the sample and the added enzyme-T3 conjugate for a limited number of antibody combining sites. After the completion of the incubation period, the enzyme-T3 conjugate is separated from unreacted material by decantation. The activity of the enzyme on the well is quantitated by reaction with suitable substrate to produce color.
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 120 specimens from hypothyroid, euthyroid and hyperthyroid populations. The mean values for reference method (coated tube RIA) and this method (microplate EIA) are 168 and 162 respectively. The equation to a straight line (y= 3.8 + 0.947) and correlation coefficient (0.987) indicates good method agreement.
In addition recovery data demonstrated an average recovery of 102.1% when exogenous added triiodothyronine was introduced into human serum specimens. Similarly, linearity studies showed an average 95.7% when specimens were diluted and compared to the dose response curve.
Key Metrics
Recovery: 102.1%, Linearity: 95.7%, Correlation coefficient: 0.987
Predicate Device(s)
Monobind total triiodothyronine (T3) coated tube radioimmunoassay (RIA)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1710 Total triiodothyronine test system.
(a)
Identification. A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.(b)
Classification. Class II. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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K97179
JUN 1 6 1997
Image /page/0/Picture/2 description: The image shows a 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. 9. 97
510(k) Summary
Dear Sir:
Monobind Inc. , registration number 2020726, plans to introduce into commercial distribution an enzymelmmunoassay (EIA) kit for the determination of total trilodothyronine (T3) in human serum or plasma.
The proprietary name is Total Trilodothyronine (T3) Microplate EIA and the usual name Is T3 EIA. This device classification name is - enzyme immunoassay, non-radiolabeled, total trilodothyronine - product code CPD (per 21 CRF section 862.1710).
This device is substantially equivalent to the Monobind total trilodothyronine (T3) coated tube radioimmunoassay (RIA), which predicates the new device.
The contact individual for this submission is Dr. Frederick R. Jerome.
The Monobind microplate ElA utilizes anti-trilodothyronine antibody immobilized on the surface of plastic wells of a microtiterplate. Specimens, callbrators or controls are then added followed by the enzyme-T3 conjugate. A competition reaction results between the native trilodothyronine in the sample and the added enzyme-T3 conjugate for a limited number of antibody combining sites. After the completion of the Incubation period, the enzyme-T3 conjugate is separated from unreacted material by decantation. The activity of the enzyme on the well is quantitated by reaction with suitable substrate to produce color.
The Intended use of the device: The quantitative determination of total triiodothyronine concentration in human serum or plasma by a microplate enzymelmmunoassay.
The technological characteristics of the new device compared to the predicate device are essentially identical. This includes the use of the same anti-trilodothyronine antibody (coated on a plastic surface), identically prepared callbrators, sample size and the composition of the tracer buffer. The sole difference resides in the use of an enzyme tracer compared to a radioisotope.
Substantial equivalency was based on clinical comparison (linear regression), using 120 specimens from hypothyroid, euthyroid and hyperthyroid populations. The mean values for reference method (coated tube RIA) and this method (microplate EIA) are 168 and 162 respectively. The equation to a straight line (y= 3.8 + 0.947) and correlation coefficient (0.987) Indicates good method agreement.
In addition recovery data demonstrated an average recovery of 102.1% when exogenous added trilodothyronine was introduced into human serum specimens. Similarly, linearity studies showed an average 95.7% when a specimens were diffuted 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
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
. IIIn I 6 1997
Dr. Frederick R. Jerome Monobind, Inc. 729 West 16th Street Costa Mesa, California 92627
K971779 Re: Total Triiodothyronine (T3) Microplate EIA 体 Regulatory Class: II Product Code: CDP Dated: May 9, 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 The general controls provisions of the Act 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (CMP) 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Flease 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.
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Paqe 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 requlation (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): K971779
Device Name: Total Triiodothyronine (T3) EIA
The quantitative determination of total triiodothyronine concentration in human serum or plasma by a microplate i its qualified in the more of the may be are used in the diagnosis and treatment of thyroid. diseases such as hyperthyoidism.
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510(k) Number | K971779 |
| Prescription Use
(Per 21 CFR 801.109) | | OR | Over-The-Counter Use
(Optional Folmat 1-2-96) |
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