# K980518: Osteomark

- Pathway: 510(k) (Traditional)
- Applicant: Ostex Intl., Inc.
- Decided: Mar 6, 1998 after 49 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K983674: Vitros Immunodiagnostic Products: NTX Calibrators, NTX Reagent Pack, NTX Controls (1999), 0 descendants of its own

## 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. antiresorptive therapies in postmenopausal women 2. antiresorptive therapies in individuals diagnosed with osteoporosis 3. antiresorptive therapies in individuals diagnosed with Paget’s disease of bone 4. estrogen-suppressing therapies C. Identifying the probability for a decrease in bone mineral density after one year in postmenopausal women receiving calcium supplement relative to those treated with hormonal antiresorptive therapy. The measurement range of Osteomark is 20 to 3000 nM Bone Collagen Equivalents (BCE).

Source page: https://510kreport.com/device/K980518
Methodology: https://510kreport.com/methodology