FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The ThyroChek whole blood, rapid TSH assay is a visual, non-instrument, qualitative, solid-phase, lateral now, immunochromatographic assay for identifiying capillary or venous blood sample contains TSH in a concentration ≥ 5 micro IU/ml. The test is intended for use as an in-vitro diagnostic device by medical professionals to screen for primary hypothryoidism. It is not indicated for use as a screening method for neonatal hypothyroidism.

Device Description

This new immunometric assay device is a single-use Class II medical device for professional use that is designed to indicate whether a capillary or venous blood sample contains TSH in a concentration ≥ 5 micro IU/ml. The ThyroChek whole blood, rapid TSH assay is a visual, non-instrument, qualitative, solid-phase, lateral now, immunochromatographic assay.

AI/ML Overview

{
  "1. A table of acceptance criteria and the reported device performance": {
    "Acceptance Criteria": [
      "Analytic sensitivity between 4.06-5.62 micro IU/ml (quantitative recovery data)",
      "Analytic sensitivity between 4.57-5.87 micro IU/ml (serial dilution data)",
      "Functional sensitivity of 5.0 micro IU/ml",
      "% agreement in identifying specimens with TSH>5 micro IU/ml compared to predicate second / third generation TSH assays = 99%",
      "% agreement in identifying specimens with TSH>5 micro IU/ml compared to predicate serum-based one-step rapid TSH assay = 99%",
      "No intraassay variation with 10 aliquots at 5 TSH concentrations (coefficient of variation = 0)",
      "Assay performance not affected by hCG up to 82,500 mIU/ml",
      "Assay performance not affected by LH / FSH > 25 mIU/ml",
      "Assay performance not affected by hematocrit between 14-65%",
      "Assay performance not affected by azotemia with BUN up to 70 mg% and creatinine up to 8.6 mg%",
      "Assay performance not affected by hyperglycemia with blood sugars up to 707 mg%",
      "Assay performance not affected by hyperlipidemia with serum triglycerides up to 844 mg%"
    ],
    "Reported Device Performance": [
      "Quantitative recovery data demonstrates analytic sensitivity between 4.06-5.62 micro IU/ml.",
      "Serial dilution data demonstrates analytic sensitivity between 4.57-5.87 micro IU/ml.",
      "Parallelism demonstrates functional sensitivity of 5.0 micro IU/ml.",
      "Parallelism demonstrates % agreement in identifying specimens with TSH>5 micro IU/ml compared to predicate second / third generation TSH assays = 99%.",
      "Parallelism demonstrates % agreement in identifying specimens with TSH>5 micro IU/ml compared to predicate serum-based one-step rapid TSH assay = 99%.",
      "Replicated testing with 10 aliquots at 5 TSH concentrations showed no intraassay variation (coefficient of variation = 0).",
      "Assay performance is not affected by hCG in concentrations up to 82,500 mIU/ml.",
      "Assay performance is not affected by LH / FSH in concentrations > 25 mIU/ml.",
      "Assay performance is not affected by hematocrit between 14-65%.",
      "Assay performance is not affected by azotemia with BUN up to 70 mg% and creatinine up to 8.6 mg%.",
      "Assay performance is not affected by hyperglycemia with blood sugars up to 707 mg%.",
      "Assay performance is not affected by hyperlipidemia with serum triglycerides up to 844 mg%."
    ]
  },
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The sample size and data provenance (country of origin, retrospective/prospective) for the test set are not specified in the provided text.",
  "3. 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)": "The number and qualifications of experts for establishing ground truth are not specified in the provided text.",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "The adjudication method for the test set is not specified in the provided text.",
  "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": "A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this device is a standalone in-vitro diagnostic assay, not an AI-assisted reading tool for human readers.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Yes, a standalone performance study was done for the 'ThyroChek One-Step Whole Blood Rapid TSH Assay,' as it is a qualitative, solid-phase, lateral-flow immunochromatographic assay designed to be read visually by medical professionals. The reported values directly reflect the device's performance.",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The ground truth appears to be based on comparisons to legally marketed predicate devices, including second and third-generation TSH immunoassays, and a serum-based lateral flow immunochromatographic assay. This indicates that the ground truth is established by reference to established laboratory methods for TSH measurement.",
  "8. The sample size for the training set": "The sample size for the training set is not specified in the provided text, as this is a traditional immunoassay and not an AI/machine learning model that typically undergoes a 'training' phase.",
  "9. How the ground truth for the training set was established": "Not applicable, as this is a traditional immunoassay, not an AI/machine learning model with a distinct training set and ground truth establishment methodology in the AI context."
}

Summary

Regulation Number and Section

§ 862.1690 Thyroid stimulating hormone test system.

(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.