(45 days)
The SYNCHRON Systems Thyroxine (T4) Reagent is intended for the quantitative determination of total thyroxine concentrations in serum on SYNCHRON Clinical Systems.
The SYNCHRON Systems Thyroxine (T4) Reagent kit, which includes the T4 Reagent and the T4 Calibrators, in intended for use on Beckman's SYNCHRON Clinical Systems.
Here's an analysis of the provided text regarding the SYNCHRON Systems Thyroxine (T4) Reagent, focusing on acceptance criteria and supporting studies:
This document is a 510(k) Summary of Safety & Effectiveness for an in vitro diagnostic device, not a medical imaging AI device. Therefore, many of the requested fields (like the number of experts, adjudication methods, MRMC studies, standalone performance for AI, training set details) are not applicable to this type of submission. The 'ground truth' in this context refers to the true concentration of T4 in a sample, which is established by comparison to a legally marketed predicate device.
Acceptance Criteria and Device Performance for SYNCHRON Systems Thyroxine (T4) Reagent
1. Table of Acceptance Criteria and Reported Device Performance
For in vitro diagnostic devices like this, the primary acceptance criteria revolve around demonstrating equivalence to a legally marketed predicate device through method comparison, imprecision, and stability. While explicit numerical acceptance criteria are often present in the full submission, this summary provides the performance results that are implicitly compared against such criteria to demonstrate equivalence.
| Performance Metric | Acceptance Criteria (Implied for Equivalence) | Reported Device Performance |
|---|---|---|
| Method Comparison | Slope: Close to 1.0 | |
| Intercept: Close to 0 | ||
| Correlation Coefficient (r): High (e.g., >0.95 or >0.98) | Slope: 1.018 | |
| Intercept: 0.12 µg/dL | ||
| r: 0.992 | ||
| Imprecision (Within-Run) | %C.V. should be within acceptable limits for diagnostic assays (e.g., typically |
§ 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.