# K961562: Osteomark

- Pathway: 510(k) (Traditional)
- Applicant: Ostex Intl., Inc.
- Decided: Jul 11, 1996 after 80 days
- Product code: JMM (Column Chromatography & Color Development, Hydroxyproline)
- Device class: 1
- Regulation: 21 CFR 862.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
Osteomark® is a urinary assay that provides a quantitative measure of the excretion of cross-linked N-telopeptides of type I collagen (NTX) as an indicator of human bone resorption. Elevated levels of urinary NTx indicate elevated human bone resorption. Measurement of NTx is intended for use in: A. Predicting skeletal response (bone mineral density) to hormonal anti-resorptive therapy in postmenopausal women B. Therapeutic monitoring of: 1. anti-resorptive therapies in postmenopausal women 2. anti-resorptive therapies in individuals diagnosed with osteoporosis 3. anti-resorptive therapies in individuals diagnosed with Paget’s disease of bone 4. estrogen-suppressing therapies

Source page: https://510kreport.com/device/K961562
Methodology: https://510kreport.com/methodology