(33 days)
The quantitative determination of total triiodothyronine concentration in human serum or plasma by a microplate enzymelmmunoassay. The results obtained are used in the diagnosis and treatment of thyroid diseases such as hyperthyoidism.
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). 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Monobind Total Triiodothyronine (T3) Microplate EIA:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for correlation coefficient, recovery, or linearity. However, the reported results are presented to demonstrate substantial equivalence and satisfactory performance. We can infer performance metrics from the reported data.
| Performance Metric | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Method Agreement (Linear Regression) | High correlation (e.g., >0.95) and strong linear relationship (y ≈ x) compared to predicate device | Correlation Coefficient (r) = 0.987 |
| Equation: y = 3.8 + 0.947x | ||
| Recovery | Recovery close to 100% | Average Recovery = 102.1% |
| Linearity | Linearity close to 100% | Average Linearity = 95.7% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 120 specimens.
- Data Provenance: The specimens were from "hypothyroid, euthyroid and hyperthyroid populations." The country of origin is not specified, but the company is based in Costa Mesa, CA, USA. The study appears to be retrospective, using existing specimens for comparison between the new and predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the submission. The ground truth for method agreement was established by running the samples on a predicate device (Monobind total trilodothyronine (T3) coated tube radioimmunoassay (RIA)), rather than by expert review of patient cases.
4. Adjudication Method for the Test Set
This is not applicable as the "ground truth" for the method agreement study was derived from another device's measurements, not from expert consensus or adjudication of clinical findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) immunoassay, which does not typically involve human readers interpreting results in the same way imaging devices do. The comparison was between two different assay methodologies (EIA vs. RIA).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The entire study describes the performance of the new Monobind Microplate EIA device as a standalone analytical tool, comparing its T3 measurements to those obtained from a predicate RIA device. There is no human intervention in the measurement process of the assay itself once the sample is added.
7. The Type of Ground Truth Used
The ground truth for the method agreement study was established using the measurements from a predicate device: the Monobind total trilodothyronine (T3) coated tube radioimmunoassay (RIA). For recovery and linearity studies, the ground truth was based on the known concentrations of added exogenous triiodothyronine or theoretical concentrations after dilution.
8. The Sample Size for the Training Set
The submission does not specify a separate training set. For in vitro diagnostic assays like this, the "training" (calibration curve generation) is typically part of the assay procedure using defined calibrators, and the clinical performance evaluation is done on a separate set of patient samples. The 120 specimens were used for the clinical comparison/validation study, which serves as the "test set."
9. How the Ground Truth for the Training Set was Established
As no separate training set as typically understood in machine learning was mentioned, the method for establishing ground truth for a training set is not applicable. The device uses "identically prepared calibrators" which would have known T3 concentrations, and these are used to establish the dose-response curve for the assay. The ground truth for these calibrators would be established through a rigorous measurement and validation process by the manufacturer, typically traceable to international reference standards if available.
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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
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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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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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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division Sign-Off) | |
|---|---|
| Vision of Clinical Laboratory Devices | |
| 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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§ 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.