(62 days)
The Access Total T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access® Immunoassay Systems. The Access Total T4 assay provides in vitro quantitative measurement of total thyroxine (T4) levels in human serum or plasma. The Access Total T4 assay is indicated for use with patients where an evaluation of their thyroid status is desired.
The Access® Total T4 assay consists of the reagent pack and calibrators. Consumables required for the assay include substrate and wash buffers.
Here's an analysis of the provided text regarding the Access® Total T4 assay's acceptance criteria and studies:
Based on the provided 510(k) summary, the device Access Total T4 is being cleared based on substantial equivalence to a previously cleared Access Total T4 assay (K926475). The primary change in this new submission is the expansion of sample type to include human plasma samples. Therefore, the acceptance criteria and the study focus primarily on demonstrating that the performance of the assay with plasma samples is comparable to its performance with serum samples.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state specific numerical acceptance criteria (e.g., correlation coefficient thresholds, bias limits, or ranges of agreement) for the method correlation study. It only states a qualitative outcome.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Good correlation between plasma and serum samples in method comparison study (implied for substantial equivalence). | "Study results demonstrate good correlation between the plasma and serum samples." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The exact number of paired plasma and serum samples used in the method correlation study is not specified in the provided document. It only states "paired plasma and serum samples."
- Data Provenance: The country of origin is not specified. The study is a prospective method correlation study where paired samples were collected and tested.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the study described is a method correlation study for an in vitro diagnostic (IVD) assay, not a study requiring expert readers to establish ground truth for image or clinical interpretation. The ground truth for this type of assay is derived from the established analytical performance of the predicate device and the new device.
4. Adjudication Method for the Test Set
This information is not applicable for a method correlation study of an IVD assay. Adjudication methods are typically associated with studies involving human interpretation or subjective assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging or diagnostic aids that involve human interpretation. This submission concerns an in vitro diagnostic assay with a quantitative output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in spirit. The study described is an analytical performance study of the device itself (the Access Total T4 assay) generating quantitative results. There is no human interpretation involved in the final result generation by the device. The study demonstrates the device's performance in analyzing plasma and comparing it to serum.
7. The Type of Ground Truth Used
The ground truth for the method correlation study is implicitly the results obtained from the predicate device (or the same device running on the serum sample). The objective is to show the new sample type (plasma) yields results comparable to the established sample type (serum) using the same assay.
8. The Sample Size for the Training Set
This information is not applicable as the Access Total T4 assay described is an IVD assay (a chemical assay), not an AI/ML algorithm that requires a "training set" in the computational sense. The device is a direct measurement system.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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.