TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 by BIOCHECK, INC.

The BioCheck Total T3 EIA is intended for the quantitative determination of triiodothyronine (T3) in human serum. This test is useful in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a medical device called the "BioCheck Total T3 Enzyme Immunoassay Test Kit." It concerns the regulatory approval process and does not contain detailed information about acceptance criteria or specific study results that prove the device meets those criteria.

Therefore, I cannot extract the requested information from the provided text. The document confirms that the FDA reviewed the device and found it substantially equivalent to a legally marketed predicate device, allowing it to proceed to market subject to general controls. However, it does not include the technical performance data, study design, or ground truth establishment details that would be required to answer your questions.

To elaborate on why each specific question cannot be answered:

A table of acceptance criteria and the reported device performance: This information is typically found in the submission's performance data section, which is not included in this FDA determination letter.
Sample size used for the test set and the data provenance: Not present in the document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present in the document.
Adjudication method: Not present in the document.
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 device is an "Enzyme Immunoassay Test Kit" for determining T3 levels, not an AI-assisted imaging device. Therefore, an MRMC study with human readers and AI assistance would not be relevant and is not mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a laboratory test kit, not an algorithm. Its performance is inherent to the kit's reagents and methodology. So, this question is not applicable in the context of this device.
The type of ground truth used: Not present in the document. For an immunoassay, the "ground truth" would typically refer to a reference method or validated gold standard for T3 measurement.
The sample size for the training set: Not present in the document. For an immunoassay, there wouldn't typically be a "training set" in the sense of machine learning; rather, there would be validation studies performed during development.
How the ground truth for the training set was established: Not present in the document.

In summary, the provided document is a regulatory approval letter and does not contain the detailed technical and scientific study information required to answer your questions.

Summary

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 1999

Biocheck, Inc. C/O Robin J. Hellen, M. S. Hellen Professional Services 9418 Lasaine Avenue Northridge, CA 91325

Re: K991311

Trade Name: BioCheck Total T3 Enzyme Immunoassay Test Kit Regulatory Class: II Product Code: CDP Dated: May 21, 1999 Received: May 24, 1999

Dear Ms. Hellen:

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 legally marketed predicate 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 of the Act. The general controls provisions 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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 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/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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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PART I - 510(k) Inform

III. Statement for Indications for Use

510(k) Number (if known):	K991311
Device Name:	BioCheck, Inc. Total T3 Enzyme Immunoassay Test Kit
Indications for Use:

	(Division Sign-Off) Division of Clinical Laboratory Devices
510(k) Number	K991311

Concurrence of the CDRH, Office of Device Evaluation (ODE)

Prescription Use:		OR	Over the Counter Use:
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Regulation Number and Section

§ 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.