(63 days)
Osteomark NTx Point of Care (POC) is a urinary assay for the quantitative measure of the excretion of cross-linked N-telopeptides of type I collagen (NTx) normalized to urinary creatinine (nM Bone Collagen Equivalents/mM creatinine). The test is used to monitor bone resorption changes following initiation of antiresorptive therapy (e.g., hormone replacement therapy).
Osteomark NTx Point of Care (POC) is a urinary assay for the quantitative measure of the excretion of cross-linked N-telopeptides of type I collagen (NTx) normalized to urinary creatinine (nM Bone Collagen Equivalents/mM creatinine).
This document is a 510(k) clearance letter from the FDA for a device called "OSTEOMARK® NTx Point of Care (POC)". It is not a study report, and therefore, it does not contain the detailed information necessary to answer the questions about acceptance criteria and study design.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or details on training sets.
- Information on ground truth establishment (number of experts, qualifications, adjudication method, type of ground truth).
- Details on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone performance.
The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It refers to the "Indications For Use" which describes what the device does (measures N-telopeptides of type I collagen to monitor bone resorption changes following antiresorptive therapy).
To answer these questions, you would need to refer to the actual 510(k) submission document (K992997) or other study reports related to the OSTEOMARK® NTx Point of Care (POC) device, which are not included in this provided text.
§ 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.