K Number
K980088
Device Name
T-UPTAKE MICROPLATE EIA
Manufacturer
Date Cleared
1998-02-04

(26 days)

Product Code
Regulation Number
862.1715
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
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.
More Information

Monobind T3 Uptake radioassay (RIA)

Not Found

No
The device description details a standard enzyme immunoassay (EIA) method for measuring thyroid hormone binding sites. There is no mention of AI, ML, or any computational methods beyond basic data analysis for constructing a dose-response curve and performing linear regression for method comparison.

No
The device measures thyroid hormone binding sites to aid in diagnosis, it does not directly treat or prevent a disease.

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states, "Measurements obtained from this device are used in the diagnosis and treatment of thyroid diseases."

No

The device description clearly outlines a microplate enzyme immunoassay (EIA) which involves physical components like plastic wells, antibodies, enzyme conjugates, and substrates, 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 Measurement of the Total Amount of Binding Sites Available for the Thyroid Hormones in Human Serum or Plasma... Measurements obtained from this device are used in the diagnosis and treatment of thyroid diseases." 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-based assay (microplate enzyme immunoassay) performed on human specimens.
  • Performance Studies: The performance studies involve testing human specimens from different patient populations (hypothyroid, pregnant, euthyroid, and hyperthyroid) and comparing the results to a reference method.

These characteristics align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease.

N/A

Intended Use / Indications for Use

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.

Product codes

KHQ

Device Description

The Monobind microplate EIA utilizes limited amount of anti-thyroxine antibody coated on the surface of plastic wells of a microtiter. Specimens, calibrators, or controls are then added. The enzyme-T4 conjugate and thyroxine. The line in tube added antibody processor of the least be slight or the enzyme only gets to specimen increases. After the completion of the incubation period, the enzyme-T4 on the well is quantitated by reaction with suitable substrates. The activity of the 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Substantial equivalency was based on clinical comparison (linear regression), using 120 specimens from hypothyroid, pregnant, euthyroid and hyperthyroid populations. The mean values for reference method (radioassay) and this method (microplate EIA) are 20.0 and 29.3 respectively. The equation to a straight line (y= 1.56 + 0.96x) and correlation coefficient (0.972) indicates good method agreement.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Correlation coefficient (0.972).

Predicate Device(s)

Monobind T3 Uptake radioassay (RIA)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

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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.

K980088

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

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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.

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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

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) NumberK950088

| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Folmat 1-2-96) |

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