(260 days)
FREND™ TSH is designed for in vitro DIAGNOSTIC USE ONLY for the quantitative measurement of Thyroid Stimulating Hormone (thyrotropin or TSH) in human serum and lithium heparin plasma using the FREND™ system.
FREND™ TSH is indicated for use in clinical laboratories upon prescription by the attending physician as an aid to clinicians in the diagnosis of thyroid disease.
The FREND™ System is a bench top fluorescence reader containing a simple computerized touchscreen user interface, easily manipulated to order tests, display results and operate the mechanical functions of the instrument. The specimen is added with a transfer pipette to the sample inlet of a single use cartridge by the operator, allowing the appropriate volume of sample (35 uL) to be delivered into the FREND™ TSH cartridge. The cartridge is then placed into the FREND™ system, which is programmed to begin analysis once the sample has reacted with the reagents. All reactions occur in the self-contained plastic cartridge and the reading is done in the cartridge as well. The FREND™ system has a slot that accepts the FREND™ TSH test cartridge containing the reagents and sample, and is programmed to analyze the test when the sample has fully reacted with the on-board in-cartridge reagents. Cartridges are loaded manually one by the operator. The reaction and analysis time is approximately 5 minutes. TSH quantitation is based on the ratio of fluorescence detected by the FREND™ System at the FREND™ TSH test and reference windows in the plastic cartridge compared to a standard curve stored in the TSH Code Chip that is included with each box of the device. A higher ratio of fluorescence is indicative of a higher TSH concentration. In other words, the magnitude of the fluorescent ratio is directly proportional to the amount of TSH in the sample.
The FREND™ TSH device is an in vitro diagnostic test for the quantitative measurement of TSH in human serum and lithium heparin plasma. The study aimed to demonstrate its substantial equivalence to a legally marketed predicate device, the TOSOH ST AIA-PACK TSH (K972586), to support its 510(k) premarket notification.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied by equivalence to predicate or clinical guidelines) | Reported Device Performance (FREND™ TSH) |
|---|---|---|
| Accuracy (Linearity) | Linearity over the measurement interval with non-linearity less than allowable (20% up to 1 mIU/L, then 10%). | Linear from |
§ 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.