(120 days)
Measurement of Dpd is intended for use as an aid in monitoring bone resorption changes in postmenopausal women receiving hormonal or bisphosphonate antiresorptive therapies and in individuals diagnosed with osteoporosis.
Not Found
The provided document is an FDA 510(k) clearance letter for the Pyrilinks®-D Assay Kit. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.
Therefore, I cannot provide the requested information from this document. The letter is administrative in nature, confirming regulatory clearance, but it does not delve into the technical details of the performance study that would have been submitted to the FDA.
§ 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.