(74 days)
Pyrilinks-D is a urinary assay that provides a quantitative measure of the excretion of deoxypyridinoline (Dpd) crosslinks as an indicator of bone resorption. Elevated levels of urinary Dpd indicate elevated bone resorption in individuals. Measurement of Dpd is intended for use in monitoring bone resorption changes in postmenopausal women receiving antiresorptive therapies and in individuals diagnosed with osteoporosis.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the Pyrilinks®-D Assay, a urinary assay for deoxypyridinoline (Dpd) crosslinks. This document does not contain information regarding detailed acceptance criteria, specific study designs, or performance metrics in the format requested. It primarily focuses on the regulatory aspects of the device's clearance based on substantial equivalence.
Therefore, I cannot extract the information required to populate the table and answer the study-related questions from this document. The letter states that the device is "substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976," implying that its performance was assessed against predicate devices, but the specifics of that assessment are not detailed here.
§ 862.1400 Hydroxyproline test system.
(a)
Identification. A hydroxyproline test system is a device intended to measure the amino acid hydroxyproline in urine. Hydroxyproline measurements are used in the diagnosis and treatment of various collagen (connective tissue) diseases, bone disease such as Paget's disease, and endocrine disorders such as hyperparathyroidism and hyperthyroidism.(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.