(117 days)
Teco Direct HDL/LDL Calibrator is used for the calibration of Teco Diagnostics' Direct HDL and Direct LDL Cholesterol Reagent Set in serum or plasma and with Teco Direct HDL Cholesterol Reagent for the quantitative determination of high density lipoprotein cholesterol (HDL-C) in human serum or plasma. HDL quantitative determination is used in identifying patients who are at a higher risk for coronary heart diseases. Low HDL cholesterol levels are associated with an increased risk. This reagent set is intended for in vitro diagnostic use only.
Direct HDL Cholesterol Reagent and Direct HDL/LDL Calibrator
This document is a 510(k) premarket notification for a diagnostic reagent and calibrator (Direct HDL Cholesterol Reagent and Direct HDL/LDL Calibrator). As such, it is not a study document that details acceptance criteria and performance of a device in the way a clinical trial or AI/ML device study would.
Therefore, the requested information elements (1-9) which are typically associated with performance studies of medical devices, especially AI/ML-driven ones, cannot be extracted from this regulatory approval letter.
Instead, this document confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its approval. The "Indications for Use" section specifies the intended purpose of the device: "quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum or plasma." It also mentions that "Low HDL cholesterol levels are associated with an increased risk" for coronary heart diseases, and the reagent set is intended for "in vitro diagnostic use only."
To provide the kind of detail requested about acceptance criteria and study performance, one would need to refer to the original 510(k) submission document (K050623), which would contain the performance data and equivalence claims against the predicate device. This approval letter references that submission but does not contain the detailed study information itself.
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.