TOTAL THROXINE MICROPLATE EIA(225-300) by MONOBIND

The quantitative determination of total thyroxine concentration in human serum or plasma by a microplate enzymeimmunoassay.Measurements obtained from this device are used in the diagnosis and treatment of thyroid diseases.

Device Description

Monobind Inc. , registration number 2020726, plans to introduce into commercial distribution an enzymelmmunoassay (EIA) kit for the determination of total thyroxine (T4) In human serum or plasma. The proprietary name is Total Thyroxine (T4) Microplate EIA and the usual name is T4 EIA. This device classification name is - enzyme immunoassay, non-radiolabeled, total thyroxine - product code 75KLI (per 21 CRF section 862.1700). The Monobind microplate EIA utilizes anti-thyroxine antibody immobilized on the surface of plastic wells of a microtiterplate. Specimens, calibrators or controls are then added followed by the enzyme-T4 conjugate. A competition reaction results between the native thyroxine in the sample and the added enzyme-T4 conjugate for a limited number of antibody combining sites. After the completion of the incubation period, the enzyme-T4 conlugate 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Total Thyroxine (T4) Microplate EIA device, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Correlation Coefficient (r) indicating good method agreement	0.934
Equation to a straight line (linear regression)	y = 0.39 + 0.952x
Average recovery for exogenous added thyroxine	101.1%
Average linearity for diluted specimens	101.2%
Mean value for reference method (coated tube RIA)	8.07
Mean value for new method (microplate EIA)	8.06

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: 131 specimens
- Data Provenance: The specimens were from "hypothyroid, euthyroid and hyperthyroid populations." The country of origin is not specified, nor is whether the data was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. The ground truth was established by a predicate device, not human experts for this specific comparison.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. The comparison was against a predicate device, not through human expert adjudication.
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:
- Not applicable. This is not an AI device, and no MRMC study was conducted. The study was a "clinical comparison (linear regression)" against a predicate device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, in a sense. The device itself (the microplate EIA) was evaluated in comparison to a predicate device (coated tube RIA) to establish substantial equivalence. Human involvement is primarily in performing the lab test, not in interpreting AI output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established by a predicate device: the Monobind total thyroxine (T4) coated tube radioimmunoassay (RIA).
The sample size for the training set:
- Not explicitly mentioned. This is a traditional immunoassay device, not a machine learning or AI algorithm that typically uses a "training set" in the same way. The development of such assays involves optimization and validation steps, but not a distinct "training set" as understood in AI/ML context.
How the ground truth for the training set was established:
- Not applicable, as there isn't a traditional "training set" for AI/ML in this context. The underlying principles and performance of immunoassays are established through biochemical and analytical validation, not through ground truthing of a data set in the AI sense.

Summary

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K971709

JUN 1 6 1997

Image /page/0/Picture/2 description: The image is a logo for MONOBIND, INC. The logo features a stylized, interconnected design resembling the letters 'm' and 'b' stacked on top of each other. The letters are bold and black, creating a strong visual impact. Below the symbol, the company name "MONOBIND, INC." is printed in a simple, sans-serif font.

May. 7, 97

510(k) Summarv

Dear Sir:

Monobind Inc. , registration number 2020726, plans to introduce into commercial distribution an enzymelmmunoassay (EIA) kit for the determination of total thyroxine (T4) In human serum or plasma.

The proprietary name is Total Thyroxine (T4) Microplate EIA and the usual name is T4 EIA. This device classification name is - enzyme immunoassay, non-radiolabeled, total thyroxine - product code 75KLI (per 21 CRF section 862.1700).

This device is substantially equivalent to the Monobind total thyroxine (T4) coated tube radioimmunoassay (RIA), which predicates the new device.

The contact individual for this submission is Dr. Frederick R. Jerome.

The Monobind microplate EIA utilizes anti-thyroxine antibody immobilized on the surface of plastic wells of a microtiterplate. Specimens, calibrators or controls are then added followed by the enzyme-T4 conjugate. A competition reaction results between the native thyroxine in the sample and the added enzyme-T4 conjugate for a limited number of antibody combining sites. After the completion of the incubation period, the enzyme-T4 conlugate 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 thyroxine 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-thyroxine 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 131 specimens from hypothyroid, euthyroid and hyperthyroid populations. The mean values for reference method (coated tube RIA) and this method (microplate EIA) are 8.07 and 8.06 respectively. The equation to a straight line (y= 0.39 + 0.952) and correlation coefficient (0.934) indicates good method agreement.

In addition recovery data demonstrated an average recovery of 101.1% when exogenous added thyroxine was introduced into human serum specimens. Similarly, linearly studies showed an average 101.2% when a specimen was 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

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Public Health Service

JUN 16 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

K971709 Re: Total Throxine Microplate EIA (225-300) 学 Regulatory Class: II Product Code: KLI Dated: May 7, 1997 Received: May 8, 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 requlations 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 (GMP) requlation (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 the Federal Reqister. Please 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 requlations.

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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 acborizoof 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.

:李 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 Autman

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): K971709

Device Name: Total Thyroxine (T4) Microplate EIA

体

(Division Sign-Off
Division of Clinical Laboratory vices
510(k) Number. 974709

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Folmat 1-2-96)

Regulation Number and Section

§ 862.1700 Total thyroxine test system.

(a)
Identification. A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II (special controls). 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.