(24 days)
This in vitro method is intended to quantitatively measure Free T3 in human serum on a Technicon Immuno-1 system. Measurements of Free T3 are used in the diagnosis and treatment of thyroid diseases.
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The request asks to describe the acceptance criteria and the study proving the device meets these criteria, based on the provided text.
Based on the provided text, the "Free T3 Method for Bayer Technicon Immuno 1® System" is being compared to a "Clinical Assays 'GammaCoat' Free T3 RIA kit" (predicate device) to demonstrate substantial equivalence. The acceptance criteria are implicitly derived from the performance characteristics of the predicate device, with the Immuno 1 Free T3 method demonstrating comparable or superior performance.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as target values but are inferred from the performance of the predicate device (Clinical Assays Free T3 method). The new device (Immuno 1 Free T3) is shown to have comparable performance.
| Performance Metric | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Immuno 1 Free T3) |
|---|---|---|
| Minimum Detectable Conc. | 0.02 pg/mL | 0.2 pg/mL |
| Precision (Between-Run) | ||
| - at 2.2 pg/mL | 6.9% | 8.2% (at 1.7 pg/mL) |
| - at 8.3 pg/mL | 7.1% | 4.1% (at 5.4 pg/mL) |
| - at 15.8 pg/mL | 8.4% | 2.7% (at 12.8 pg/mL) |
| Correlation | (Reference: Clinical Assays Free T3 method) | y = 0.95x - 0.08 |
| r = 0.94 | ||
| Svx = 0.71 pg/mL | ||
| (where y = Immuno 1, x = Clinical Assays, n = 103) | ||
| Specificity (% Crossreactivity) | (Immuton 1 performance generally comparable to or better than Clinical Assays for reported substances) | |
| Diiodo-L-tyrosine |
§ 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.