(26 days)
The Measurement of the Total Amount of Binding Sites Available for the Thyroid Hormones in Human Serum or Plasma by a Microplate Enzyme Immunossay. Measurements obtained from this device are used in the diagnosis and treatment of thyroid diseases.
The Monobind microplate EIA utilizes limited amount of anti-thyroxine antibody coated on the surface of plastic wells of a microtiter plate. Specimens, calibrators or controls are then added followed by the enzyme-T4 conjugate and thyroxine. The amount of enzyme only gets to the specimen increases. After the completion of the incubation period, the enzyme-T4 conjugate on the well is quantitated by reaction with suitable substrate. The activity of the enzyme is inversely proportional to the amount of unsaturated thyroid hormone binding sites in the specimen. The employment of several serum references of known unsaturated thyroid hormone binding capacity permits construction of a graph of absorbance and concentration. From comparison to the dose response curve, an unknown specimen's absorbance can be correlated with thyroid hormone binding capacity.
Here's an analysis of the provided text to extract information about the acceptance criteria and study for the Monobind T-Uptake Microplate EIA device:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state formal "acceptance criteria" in a quantitative manner (e.g., "sensitivity must be >X%, specificity >Y%"). Instead, it focuses on demonstrating "substantial equivalency" to a predicate device. The primary performance metric reported to support this equivalency is related to method agreement.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalency to Predicate Device: The new device (T-Uptake Microplate EIA) must demonstrate performance comparable to the predicate device (Monobind T3 Uptake radioassay). This is assessed through clinical comparison to establish method agreement. | Clinical Comparison (Linear Regression): - Sample Size: 120 specimens - Specimen Types: Hypothyroid, pregnant, euthyroid, and hyperthyroid populations. - Mean Values: • Reference method (radioassay): 29.0 • This method (microplate EIA): 29.3 - Linear Regression Equation: y = 1.56 + 0.96x - Correlation Coefficient: 0.972 Conclusion: These results "indicate good method agreement," suggesting substantial equivalency. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 120 specimens.
- Data Provenance: Not explicitly stated (e.g., country of origin). The data is described as "clinical comparison" using specimens from different patient populations, suggesting it is retrospective or prospective clinical data collected for the purpose of this comparison. It is not stated as simulated data.
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 document. The ground truth for the test set is established by the predicate device (Monobind T3 Uptake radioassay), not by human experts adjudicating results.
4. Adjudication Method for the Test Set
This information is not applicable as the ground truth for the test set was established by the predicate device's measurements, not by human expert adjudication.
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
This is not applicable. The device is an immunoassay (laboratory test), not an AI-assisted diagnostic imaging or interpretation tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the study presented is a standalone performance study for the Monobind T-Uptake Microplate EIA. The device itself performs the measurement, and its results are compared directly to those of the predicate device. There is no human-in-the-loop aspect described for the performance evaluation of the device output itself, though human involvement is required for specimen collection, assay performance, and result interpretation in a clinical setting.
7. The Type of Ground Truth Used
The ground truth used for performance evaluation (specifically, establishing substantial equivalence) was the measurements obtained from a legally marketed predicate device (Monobind T3 Uptake radioassay). This serves as the "reference method" against which the new device's performance is compared.
8. The Sample Size for the Training Set
The document does not explicitly mention a separate "training set". For immunoassay development, reference materials, calibrators, and perhaps internal development studies would be used during the R&D phase to optimize the assay. However, the provided text describes the validation/clinical comparison study for regulatory submission, which is analogous to a test set in the context of demonstrating performance for regulatory approval.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" is disclosed in the provided document, the method for establishing its ground truth is not available. However, typically for an immunoassay, the "ground truth" for developing and optimizing calibrators and controls (which might be considered analogous to training data in some contexts) would be based on established analytical methods, certified reference materials, or clinical samples with known characteristics, often determined by reference laboratories or established predicate methods.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the text "FEB 4 1998" in a slightly distorted and rotated manner. The text is printed in a bold, sans-serif font, with "FEB" appearing on the left, followed by "4" and then "1998" on the right. The date is likely a stamp or printed on a document.
KEJ
Image /page/0/Picture/1 description: The image shows a logo for Monobind, Inc. The logo features a stylized, bold letter "B" design. Below the "B" is the text "MONOBIND, INC." in a bold, sans-serif font.
Jan. 7, 98
510(k) Summary
Dear Sir:
Monobind inc., registedion number 2020726, piane to introduce into commercial thyrold hormone binding sites in human serum or plasma.
The proprietery name is T-Uptake (TV). Morquiste EIA and the usual neme le T-Uptake
EIA. This device classification name is - Tifledothyronine (T3) uptake test staten, product code KHQ fper 21 CRF section 862.1716).
This device is substantially equivalent to the Monobind T3 Uptake radioessay (RA), which predicates the new device.
The contact includual for this submission is Dr. Frederick R. Jerome.
The Monobind micropiate EIA utilizes limited amount of anti-inyroxine antibochy ritorial on the surface of plastic wells of a microllers. Speciments, collexiors
or controle are there seded by the enzyme-Te conjugate and thyrozine. The line in the added t ondageness antalig processor of the least be alight of the excyme only gets to epocimen increases. After the completion of the inculbetion portod, the eacyme-T4
onlyne on the well le quantitated by reaction with sultable substrator. The activity of the The employment of several serum references of known unsaturated thyrold hormone binding capacity permits construction of a graph of absorbance and concentration. From comparison to the dose response curve, an unknown specimen's absorbance can be correlated with thyrold hormone binding capacity
The intended use of the device: The Measurement of the Total Amount of Binding Sites Avaliable for the Thyrold Hormones in Human Serum or Plasma by a Micropiate Enzyme Immunossay.
The technological characteristics of the new device compared to the predicate device are seeentially identical. This includes identically propered callbrators, and the saturation of binding proteins with exogencusly added thyrold hormone. Main differences reside in the use of an enzyme tracer compared to a radiciscone. T4 versus T3 as the salurating thyroid hormons and antibody to plck up the unreacted thyrold hormones versus denatured albumin in the radioassay.
Substantial equivalency was based on clinical comparison filmear regression), using 120 specimens from hypothyroid, pregnant, euthyroid and hyperthyrold populations. The mean values for reference method (radicaseey) and this method (microplate EIA) are 20.0 and 29.3 respectively. The equation to a straight line (y= 1.56 + 0.966) and correlation cosficient (0.972) indicates good method sqreement.
726 West 16" Street , Costa Moss , CA (USA) 92627 Phone: (714) 642-4830 FAX: (714) 850-8459
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is in a sans-serif font.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 4 1998
Dr. Frederick R. Jerome · President Monobind, Inc. 729 West 16th Street Costa Mesa, California 92627
K980088 Re : T-Uptake Microplate EIA Regulatory Class: II Product Code: KHQ Dated: January 8,1998 Received: January 9, 1998
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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register.
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.
{2}------------------------------------------------
Page 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 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
{3}------------------------------------------------
Indications for Use Statement
| 510(k) Number (if known): | |
|---|---|
| --------------------------- | -- |
Device Name: T-Uptake Microplate EIA
The Measurement of the Total Amount of Binding Sites Available for the Thyroid Hormones in Human Serum or Plasma by a Microplate Enzyme Immunoassay. Measurements obtained from this device are used in the diagnosis and treatment of thyroid diseases.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Divi | |
|---|---|
| Division | |
| 510(k) Number | K950088 |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use(Optional Folmat 1-2-96) |
|---|---|---|
| ------------------------------------------ | ---- | -------------------------------------------------- |
§ 862.1715 Triiodothyronine uptake test system.
(a)
Identification. A triiodothyronine uptake test system is a device intended to measure the total amount of binding sites available for binding thyroid hormone on the thyroxine-binding proteins, thyroid-binding globulin, thyroxine-binding prealbumin, and albumin of serum and plasma. The device provides an indirect measurement of thyrkoxine levels in serum and plasma. Measurements of triiodothyronine uptake are used in the diagnosis and treatment of thyroid disorders.(b)
Classification. Class II. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.