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K Number
K991311
Device Name
TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005
Manufacturer
BIOCHECK, INC.
Date Cleared
1999-06-02

(47 days)

Product Code
CDP
Regulation Number
862.1710
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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:

  1. 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.
  2. Sample size used for the test set and the data provenance: Not present in the document.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present in the document.
  4. Adjudication method: Not present in the document.
  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 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.

§ 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.