(238 days)
The FT4L method is an in vitro diagnostic test for the quantitative measurement of Free Thyroxine in human serum and plasma on the Dimension® EXL™ integrated chemistry system with LOCI® Module. Measurements of free thyroxine are used in the diagnosis and monitoring of thyroid disease.
The TSHL method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone (TSH, thyrotropin) in human serum and plasma on the Dimension® EXL™ integrated chemistry system with LOCI® Module. Measurements of TSH are used in the diagnosis and monitoring of thyroid disease.
The Dimension® LOCI Free Thyroxine Flex® reagent cartridge, FT4L and Dimension® LOCI Thyroid Stimulating Hormone Flex® reagent cartridge, TSHL are in vitro diagnostic tests for the quantitative measurement of Free Thyroxine and Thyroid Stimulating Hormone, respectively, in human serum and plasma on the Dimension® EXL™ integrated chemistry system with LOCI® Module. The submission is for the inclusion of pediatric reference intervals to the labeling (Package Inserts) of these assays. No changes were made to the reagents, device design, or manufacturing process.
The provided document is a 510(k) summary for the Siemens Healthcare Diagnostics Dimension® LOCI Free Thyroxine Flex® Reagent Cartridge (FT4L) and Dimension® LOCI Thyroid Stimulating Hormone Flex® Reagent Cartridge (TSHL). The focus of this submission is the addition of pediatric reference intervals to the existing devices, not a primary submission for a new device. Therefore, the information provided primarily pertains to the establishment of these pediatric reference intervals.
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1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the pediatric reference intervals are defined by the statistical methods used to establish them and the resulting intervals. The performance reported is the calculated pediatric reference intervals.
| Acceptance Criteria | Reported Device Performance (FT4L) | Reported Device Performance (TSHL) |
|---|---|---|
| Infant (01-23 months): Reference interval established using robust symmetrical method due to sample size |
§ 862.1695 Free thyroxine test system.
(a)
Identification. A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II.